Unmet Need in Advanced Ovarian Cancer Therapy
PAOLA-1 Data Story
HRD Testing in Ovarian Cancer
Testing and Treatment Guidelines
FAQ Summary
Resource Library
*Testing does not guarantee particular clinical outcomes. Results may vary and LYNPARZA may not work for everyone.
HRD testing can help identify patients with HRD-positive advanced ovarian cancer who are eligible for certain targeted therapies.1
TEST TO TREAT
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Ovarian cancer is the most common cause of death among gynecologic cancers.2 Women with advanced (stage III or IV) ovarian cancer are at high (≥70%) risk of disease recurrence.3 About half of high-grade serous ovarian cancers exhibit homologous recombination deficiency (HRD); HRD status can guide treatment decisions.1,4,5
TEST TO INFORM TREATMENT DECISIONS
LYNPARZA® (olaparib) plus bevacizumab is a maintenance treatment option for select patients with homologous recombination deficiency (HRD)-positive† advanced ovarian cancer.1 LYNPARZA in combination with bevacizumab is the only maintenance combination therapy to demonstrate a clinically meaningful improvement in progression-free survival (PFS), and overall survival (OS) outcomes in patients with HRD-positive† disease after response to first-line chemotherapy, based on the PAOLA-1 clinical trial.1,6-9‡
TEST TO GUIDE PERSONALIZED THERAPY
Advanced ovarian cancer is a biomarker-driven disease. HRD testing at diagnosis is recommended by guidelines and is critical to inform an optimal treatment plan.10,11 Testing for HRD is required to identify patients eligible for LYNPARZA plus bevacizumab.1 Myriad MyChoice® CDx is the FDA-approved CDx used to identify patients with HRD-positive† disease eligible for LYNPARZA plus bevacizumab.12
†Including breast cancer gene (BRCA) mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.6,10 ‡Prespecified exploratory analysis of PFS and secondary endpoint OS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only.6
HRD Testing in Advanced Ovarian Cancer
Dr Lewin and Dr Chase discuss issues surrounding HRD testing and poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy in patients with advanced ovarian cancer.
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HCP Polling Station
Which of the following is most likely to influence you to test for HRD in patients with ovarian cancer?
Clinical practice guidelines
Treatment decision-making and broadening access to therapies
Risk of relapse
Disease progression
Other
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What are the most significant barriers for HRD testing in your practice?
Lack of understanding of the distinction between HRD and BRCA testing
Concerns about testing coverage and reimbursement
Insufficient amount of tumor tissue
Turnaround time
Lack of access to genetic counselors
HCP Website
Precision Medicine Ovarian Cancer Site
US Prescribing Information
Request Medical Information
AstraZeneca Privacy Notice
©2026 AstraZeneca. All rights reserved. US-109107 Last Updated 4/26 LYNPARZA is a registered trademark of the AstraZeneca group of companies.
References
LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. American Cancer Society (ACS). Cancer Facts & Figures 2025. Atlanta, GA; 2025. Accessed August 27, 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf Ovarian Cancer Research Alliance. Recurrence. Accessed August 27, 2025. https://ocrahope.org/patients/about-ovarian-cancer/recurrence/ Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov. 2015;5(11):1137-1154. Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2014;20(3):764-775. Ray-Coquard I, Leary A, Pignata S, et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2023;34(8):681-692. Hardesty MM, Krivak TC, Wright GS, et al. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol. 2022;166(2):219-229. Monk BJ, Oaknin A, O’Malley DM, et al. LBA30 ATHENA-COMBO, a phase III, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC). Ann Oncol. 2024;35:S1223-S1224. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014;32(12):1277-1280. González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO Guideline update. J Clin Oncol. 2025;43(7):868-891. Myriad Genetic Laboratories, Inc. Myriad MyChoice® CDx Technical Information. Accessed June 30, 2025. https://s3.amazonaws.com/myriad-web/myChoiceCDx/downloads/myChoiceCDxTech.pdf.
Abbreviations:
CDx, companion diagnostic; FDA, US Food and Drug Administration; OS, overall survival; PFS, progression-free survival.
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Poor Prognosis and Recurrence
Prolonging Remission
Testing Rates
LYNPARZA Plus Bevacizumab
Why Use Combination Maintenance Therapy?
Patients with advanced ovarian cancer have a poor prognosis, and most will experience disease recurrence.1-3 Biomarker testing is critical to optimize treatment plans.4,5
Ovarian cancer is the most common cause of death among gynecologic cancers in the US.6
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75% of patients are diagnosed with disease that has spread beyond the ovaries.2
70%–95% of patients with advanced ovarian cancer will experience disease recurrence.1
Women with advanced ovarian cancer are at risk of relapse.9
Patients with relapsed ovarian cancer tend to experience multiple relapses and undergo multiple rounds of therapy.10
Relapsed ovarian cancer is considered incurable.3,9
In which of the following patients with advanced ovarian cancer are you likely to use active surveillance (no active treatment) rather than maintenance therapy?
Patients with homologous recombination deficiency (HRD)-negative disease
Patients with low-risk* disease (eg, stage III with optimal debulking)
None, I try to use maintenance therapy in all patients
*There is no clinical consensus or standard clinical definition of "high-risk" or "low-risk" advanced ovarian cancer.
The treatment goal in some patients with ovarian cancer (particularly those with stage II and III disease) is long-term remission.16
Unmet Need
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Physician Perspectives on Unmet Needs in Advanced Ovarian Cancer
Dr David O’Malley explains why there is no ‘low-risk’ advanced ovarian cancer.
“…if you have 85% chance of recurring, how can you be low risk?”
Dr John Chan emphasizes that all women are at risk of recurrence and the goal of maintenance therapy is to increase the treatment-free interval.
“All women with stage III or IV ovarian cancer are at high risk of recurrence”
HRD testing is critical to inform eligibility of patients with advanced ovarian cancer for the PAOLA-1 treatment regimen.19
About half of the women with high-grade serous ovarian cancers exhibit HRD.20,21
1 in 2 patients with HRD do not have BRCA mutations but have genomic instability.20,21
BRCA/HRD status of patients with high-grade serous ovarian cancer20,21
HRD is associated with increased sensitivity to PARP inhibitor maintenance therapy.22
The FDA-approved indication of LYNPARZA plus bevacizumab requires a positive HRD test with an FDA-approved companion diagnostic.19,23
Treatment guidelines recommend genetic biomarker testing in all patients.4,24
Learn more about HRD testing guidelines
Many patients with ovarian cancer are not tested for BRCA mutations or HRD, so their eligibility for certain targeted therapies is not known.19,25
In a retrospective study of biomarker testing in 1002 patients with epithelial ovarian cancer drawn from community health systems in the US (2018–2020), 74.7% (748/1002) underwent testing, with 1 patient having an invalid test result.25
Of the 747 patients with a valid test result25: 65.5% (489/747) were tested for BRCA mutations only Only 32.8% (245/747) were tested for BRCA mutations and measures of genomic instability beyond BRCA (eg, LOH, GIS)
Learn more about HRD testing
Testing for HRD is required to identify patients eligible for LYNPARZA plus bevacizumab for first-line maintenance of HRD-positive advanced ovarian cancer after response to 1L platinum-based chemotherapy.19
The combination of LYNPARZA plus bevacizumab as first-line maintenance therapy in advanced ovarian cancer was examined in the PAOLA-1 clinical trial which showed clinically meaningful PFS and OS in HRD-positive aOC after response to 1L platinum-based chemotherapy.15
PAOLA-1 resulted in an approval for use in selected patients with HRD-positive* advanced ovarian cancer, based on an FDA-approved test.19
Treatment guidelines recommend the combination of olaparib (LYNPARZA) plus bevacizumab as first-line maintenance therapy option in selected patients with advanced ovarian cancer in complete or partial response to first-line platinum-based therapy, depending on biomarker status.4,5,18
*Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.23,27
Learn more about treatment guidelines
Dr David O’Malley discusses educating patients about maintenance therapy.
“It is no longer ‘should we be giving maintenance therapy’… it is ‘which maintenance therapy should we be giving’.”
Why use combination maintenance therapy in patients with advanced ovarian cancer?
The PARP inhibitor LYNPARZA® (olaparib) is used as monotherapy and in combination with the angiogenesis inhibitor bevacizumab as maintenance therapy in advanced ovarian cancer.19,28
Cancer cells may rely on distinct and complementary mechanisms for survival.29 Combination therapy with LYNPARZA plus bevacizumab was designed to target 2 mechanisms commonly seen in ovarian tumors.20,29,30
To learn about the mechanism of action* of these drugs, the rationale for using them as combination therapy, and a population-adjusted indirect treatment comparison (ITC) of the BRCA-mutated populations of the SOLO-1 (LYNPARZA) and PAOLA-1 (LYNPARZA plus bevacizumab) trials review the following slide deck and infographic.
*The exact mechanism of disease in the context of combination treatment strategies is yet to be elucidated, and the exact mechanism of action of LYNPARZA is unknown.
Rationale for Combination Maintenance Therapy
Combination Maintenance Therapy in Advanced Ovarian Cancer Infographic
Learn more about PAOLA-1
Dr Ramez Iskander explains the ITC analysis of the SOLO-1 and PAOLA-1 results.
“This analysis… was completed because currently there are no randomized controlled trials that investigate maintenance PARP inhibitor monotherapy, bevacizumab monotherapy, PARP inhibitor plus bevacizumab combination therapy, and watch-and-wait placebo.”
The design, efficacy, and safety results of the SOLO-1 and PAOLA-1 trials are described in detail on lynparzahcp.com.
See PAOLA-1 | See SOLO-1
Ovarian Cancer Research Alliance. Recurrence. Accessed August 27, 2025. https://ocrahope.org/patients/about-ovarian-cancer/recurrence/ National Cancer Institute (NCI). SEER Cancer Stat Facts: Ovarian Cancer. Bethesda, MD:2025. Accessed August 27, 2025. https://seer.cancer.gov/statfacts/html/ovary.html Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379(26):2495-2505. González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO guideline update. J Clin Oncol. 2025;43(7):868-891. American Cancer Society (ACS). Cancer Facts & Figures 2025. Atlanta, GA;2025. Accessed August 28, 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf Torre LA, Trabert B, DeSantis CE, et al. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018;68(4):284-296. Caruso G, Tomao F, Parma G, et al. Poly (ADP-ribose) polymerase inhibitors (PARPi) in ovarian cancer: Lessons learned and future directions. Int J Gynecol Cancer. 2023;33(4):431-443. Lorusso D, Mouret-Reynier M-A, Harter P, et al. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial. Int J Gynecol Cancer. 2024;34(4):550-558. Bolívar PS, Gonzalez-Benitez C, Carbonell López M, et al. Prognostic factors after the first recurrence of ovarian cancer. J Clin Med. 2025;14(2):470. Eng KH, Hanlon BM, Bradley WH, Szender JB. Prognostic factors modifying the treatment-free interval in recurrent ovarian cancer. Gynecol Oncol. 2015;139(2):228-235. Gupta S, Nag S, Aggarwal S, Rauthan A, Warrier N. Maintenance therapy for recurrent epithelial ovarian cancer: Current therapies and future perspectives – a review. J Ovarian Res. 2019;12(1):103. Dunton CJ. Management of treatment-related toxicity in advanced ovarian cancer. Oncologist. 2002;7(Suppl 5):11-19. Lutgendorf SK, Shinn E, Carter J, et al. Quality of life among long-term survivors of advanced stage ovarian cancer: A cross-sectional approach. Gynecol Oncol. 2017;146(1): 101-108. Ray-Coquard I, Leary A, Pignata S, et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2023;34(8):681-692. Coleman RL, Segunmaru Z, Simmons D, et al. Oncologists’ perspectives on discussing ‘cure’ with patients with ovarian cancer. Poster presented at: SGO 2024 Annual Meeting on Women’s Cancer; March 16-18, 2024; San Diego, CA. Chan JK, Liu J, Song J, et al. Real-world outcomes associated with poly (ADP-ribose) polymerase inhibitor monotherapy maintenance in patients with primary advanced ovarian cancer. Am J Clin Oncol. 2023;46(7):314-322. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer, Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V.3.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 27, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov. 2015;5(11):1137-1154. Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2014;20(3):764-775. Ngoi NYL, Tan DSP. The role of homologous recombination deficiency testing in ovarian cancer and its clinical implications: do we need it? ESMO Open. 2021;6(3):100144. Myriad Genetic Laboratories, Inc. Myriad MyChoice® CDx Technical Information. Accessed June 30, 2025. https://s3.amazonaws.com/myriad-web/myChoiceCDx/downloads/myChoiceCDxTech.pdf. Konstantinopoulos PA, Norquist B, Lacchetti C, et al. Germline and somatic tumor testing in epithelial ovarian cancer: ASCO guideline. J Clin Oncol. 2020;38(11):1222-1245. Matsuno RK, Williams AFO, Sweetnam C, et al. Patterns of homologous repair deficiency and BRCA1/2 testing of ovarian and breast cancers: A real-world study of patients in community health settings in the United States. JCO Oncol Adv. 2025;2(1):e2400079. Elyashiv O, Wong YN, Ledermann JA. Frontline maintenance treatment for ovarian cancer. Curr Oncol Rep. 2021;23(8):97. Ray-Coquard I, Pautier P, Pignata S, et al; PAOLA-1 Investigators . Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428. Avastin® (bevacizumab) [prescribing information]. South San Francisco, CA: Genentech, Inc; 2022. Hanahan D, Weinberg RA. Hallmarks of cancer: The next generation. Cell. 2011;144(5):646-674. Moghaddam SM, Amini A, Morris DL, Pourgholami MH. Significance of vascular endothelial growth factor in growth and peritoneal dissemination of ovarian cancer. Cancer Metastasis Rev. 2012;31(1-2):143-162.
BRCAwt, BRCA wild-type; CDx, companion diagnostic; CESD, Center for Epidemiological Studies Depression; FACT-O, Functional Assessment of Cancer Therapy – Ovarian; FDA, US Food and Drug Administration; gBRCAm, germline BRCA mutation; GIS, genomic instability score; HRD, homologous recombination deficiency; HRD+, homologous recombination deficiency-positive; HRD–, homologous recombination deficiency–negative; IPAQ-SF, International Physical Activity Questionnaire-Short Form; ITC, indirect treatment comparison; PARP, poly (ADP-ribose) polymerase; QoL, quality of life; sBRCAm, somatic BRCA mutation; SPS, Social Provisions Scale.
In the US, there were an estimated 20,890 new cases and 12,730 deaths from ovarian cancer in 2025.6 It is the sixth most common cause of cancer deaths among women, representing 4% of all deaths.6
Percent of ovarian cancer cases by stage 2*
*Data from SEER 22 (Excluding IL/MA) 2014-2020, All Races, Females by SEER Summary Stage.
Most patients are diagnosed with advanced disease.2 Patients who are diagnosed with advanced disease have a poor prognosis.3,7
5-year cause-specific survival in epithelial ovarian cancer, by stage 7*
*Data from SEER 18 Registries, United States, All Races, 2007–2013.
Prior to the introduction of poly (ADP-ribose) polymerase (PARP) inhibitors, 5-year cause-specific survival was 41% for Stage III disease and 20% for Stage IV disease7
Most patients respond to first-line surgery and platinum-based chemotherapy.4,8 However, in the absence of maintenance therapy, 70% of patients relapse within 3 years.1,8
The stage of cancer at diagnosis influences the risk of recurrence. 70%–95% of patients with advanced (stage III or IV) ovarian cancer will experience recurrence.1
Percentage of patients experiencing recurrence, by stage1*
*Study description, sample size, and patient population were not reported on the Ovarian Cancer Research Alliance website.
All patients are at risk of recurrence.9
Women with Stage III disease have a ≥70% chance of recurrence.1
Patients tend to experience multiple relapses and undergo multiple rounds of therapy.10 Following the first relapse, each subsequent line of therapy is characterized by11: Shorter treatment-free intervals11 Increased resistance to platinum-based chemotherapy11,12 Cumulative toxicity from chemotherapy, such as myelosuppression and residual neuropathy13 Decreasing QoL*14
*Methods—Participants (n=56) recruited from 5 academic medical centers and the Ovarian Cancer Research Fund Alliance completed surveys regarding QoL (FACT-O), mood (CESD), social support (SPS), physical activity (IPAQ-SF), diet, and clinical characteristics.14
Disease-free intervals in patients with advanced ovarian cancer after first relapse11
Relapsed ovarian cancer is considered incurable and most patients will die from the disease.3,9
Therefore, the first line is likely to be the best setting for treatments to help prevent recurrence.9,15
Inform Treatment Eligibility with HRD Testing
First-Line Maintenance BRCAm Advanced Ovarian Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
;2(1):e2400079.
Eligibility for LYNPARZA Therapy
Treatment Selection – Patient Cases
PAOLA-1 Design
PAOLA-1 Efficacy
PAOLA-1 Safety
BRCA and homologous recombination deficiency (HRD) testing are required to determine eligibility for LYNPARZA monotherapy and LYNPARZA plus bevacizumab combination therapy.1
Which of the following do you consider to be the most compelling argument for the use of LYNPARZA plus bevacizumab (the PAOLA-1 regimen) in eligible patients?
LYNPARZA® (olaparib) plus bevacizumab is a treatment option for selected patients with HRD-positive advanced ovarian cancer.1
LYNPARZA is approved both as monotherapy and in combination with bevacizumab as first-line maintenance therapy in selected patients with advanced ovarian cancer and both indications require a diagnostic test. The results of the SOLO-1 clinical trial of LYNPARZA supported monotherapy as a treatment for selected patients with BRCA-mutated advanced ovarian cancer1 The results of the PAOLA-1 clinical trial of LYNPARZA plus bevacizumab supported the combination as a treatment for selected patients with HRD-positive advanced ovarian cancer1
According to drug indications and treatment guidelines: Select patients with BRCA mutations are eligible for LYNPARZA monotherapy1-3 Select patients with HRD-positive disease are eligible for LYNPARZA plus bevacizumab1-3 HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score of ≥42 by Myriad MyChoice® CDx.4,5
The patient cases presented below provide examples of biomarker testing and treatment selection in hypothetical patients, identifying those eligible for LYNPARZA plus bevacizumab.
Patient Case 1: Stage IV HRD + BRCAm
Patient Case 2: Stage III HRD+ BRCAwt
Patient Case 3: Stage III HRD+ BRCAwt w/hypertension
Patient Case 4: Stage III gBRCAm
Presentation
Diagnosis
Treatment
Maintenance therapy
Full profile
Patient Profiles E-Learning Module
PAOLA-1 Trial Design
PAOLA-1 Trial Design1,5
FDA approval for LYNPARZA plus bevacizumab was based on a prespecified exploratory subgroup of patients with HRD-positive tumors (n=387)
PAOLA-1 studied LYNPARZA plus bevacizumab vs an active comparator (bevacizumab plus placebo) as maintenance therapy in HRD-positive advanced ovarian cancer after response to first-line platinum-based chemotherapy.5 PAOLA-1 was the first phase 3 trial to investigate a PARP inhibitor combination regimen against an established maintenance therapy—bevacizumab.5
PAOLA-1 Design and Efficacy
Dr Thomas J Herzog discusses the design of the PAOLA-1 trial and population.
“The treatment effect of the combination regimen was compared to an active bevacizumab control arm, not watch-and-wait placebo.”
Dr Ramez Eskander explains the lack of an olaparib monotherapy arm in the PAOLA-1 trial.
“At the time PAOLA-1 was designed, we didn’t know the SOLO-1 outcome”
PAOLA-1 Efficacy Results
Prespecified Exploratory Endpoint: PFS in the HRD-Positive Subgroup
FDA approval was based on a prespecified exploratory HRD-positive* subgroup.1,5 A prespecified exploratory subgroup analysis showed clinically meaningful PFS benefit in HRD-positive (including tumor BRCA-mutated) patients after response to first-line platinum-based chemotherapy.1,5,7† Median PFS was 3.1 years (37.2 months) with LYNPARZA plus bevacizumab vs ~1.5 years (17.7 months) with bevacizumab plus placebo5 67% risk reduction of disease progression or death; HR=0.33 (95% CI: 0.25–0.45)5 Data was based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1.8 In a prespecified exploratory analysis of HRD-negative and HRD-unknown patients, there was insufficient evidence to suggest differential efficacy between the combination of LYNPARZA plus bevacizumab and bevacizumab plus placebo.5
PFS in the HRD-positive subgroup1,5
*Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.4,5 †Prespecified exploratory analysis of PFS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 2 years.8 ‡Bevacizumab was administered for a total of up to 15 months, including the period given with chemotherapy and given as maintenance.5 §LYNPARZA was continued for up to 2 years or until progression of the underlying disease or unacceptable toxicity. Patients, who in the opinion of the treating physician could derive further benefit from continuous treatment, could be treated beyond 2 years.1 ||Patients with a complete response should stop treatment at 2 years. Patients with evidence of disease at 2 years can remain on therapy at physician discretion.1 In PAOLA-1, it was unknown how many HRD-positive patients remained on therapy longer than 2 years; therefore, results should be interpreted with caution.
Dr Ramez Eskander outlines the key efficacy results from the PAOLA-1 trial.
“This is the first and only phase three clinical trial to investigate a PARP inhibitor as a combination regimen… against an active comparator, an established maintenance therapy of bevacizumab.”
PAOLA-1 Safety Results
PAOLA-1 Safety and QoL
Common adverse reactions (ARs) with LYNPARZA were generally consistent with the known safety profile of LYNPARZA monotherapy.1 ARs and laboratory abnormalities from the primary analysis in PAOLA-1 were mostly Grades 1 and 2.1 8 out of 10 patients remained on LYNPARZA as prescribed, in combination with bevacizumab, without discontinuing due to ARs.1 Primary analysis: Fatal adverse reactions occurred in 1 patient due to concurrent pneumonia and aplastic anemia. Serious adverse reactions occurred in 31% of patients who received LYNPARZA plus bevacizumab. Serious adverse reactions in >5% of patients included hypertension (19%) and anemia (17%).1 In addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA plus bevacizumab (5%) than in those receiving placebo plus bevacizumab (1.9%)1
Primary analysis: ARs occurring in ≥10% of patients treated with LYNPARZA plus bevacizumab and ≥5% frequency compared with placebo plus bevacizumab1
*Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. †Includes asthenia and fatigue. ‡Includes anemia, anemia macrocytic, erythropenia, hematocrit decreased, hemoglobin decreased, normochromic anemia, normochromic normocytic anemia, normocytic anemia, and red blood cell count decreased. §Includes B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia, and T-lymphocyte count decreased. ||Includes leukopenia and white blood cell count decreased.
At 5-year follow-up analysis: No new safety signals were identified8 The incidence of MDS/AML/AA was 1.7% (9/535) in the LYNPARZA plus bevacizumab group and 2.2% (6/267) in the bevacizumab plus placebo group8 In the HRD-positive subgroup, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA plus bevacizumab and 2.3% (3/131) in patients who received bevacizumab plus placebo1 22 (4.1%) new primary malignancy events occurred in the LYNPARZA plus bevacizumab group and 8 (3.0%) events occurred in the bevacizumab plus placebo group8 7 (1.3%) pneumonitis events occurred in the LYNPARZA plus bevacizumab group and 2 (0.7%) events occurred in the bevacizumab plus placebo group8
Dr Herzog summarizes the safety results of PAOLA-1.
“The AE profile of LYNPARZA in PAOLA-1 was consistent with previous trials of LYNPARZA”
Dr Ramez Eskander describes safety data from the PAOLA-1 trial, including key adverse reactions (ARs) in patients receiving olaparib.
“This slide shows the adverse events that occurred in greater or equal to 10% of patients that were receiving both olaparib plus bevacizumab in the PAOLA-1 clinical trial.”
Kay Harger, RN, describes the management of nausea and fatigue in patients receiving olaparib.
“How do you help us manage these adverse events?”
Dr John Chan explains his considerations when choosing LYNPARZA monotherapy vs LYNPARZA plus bevacizumab.
“In patients who started on chemotherapy plus bevacizumab, who have a BRCA mutation… Do you stop bevacizumab, or continue bevacizumab and give them olaparib plus bevacizumab?”
In which of the following patients with advanced ovarian cancer are you LEAST likely to consider LYNPARZA plus bevacizumab as maintenance therapy?
The design, efficacy, and safety results of the PAOLA-1 trial are described in detail on lynparzahcp.com
See PAOLA-1 Design | See PAOLA-1 Efficacy | See PAOLA-1 Safety
LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO guideline update. J Clin Oncol. 2025;43(7):868-891. Myriad Genetic Laboratories, Inc. Myriad MyChoice® CDx Technical Information. Accessed June 30, 2025. https://s3.amazonaws.com/myriad-web/myChoiceCDx/downloads/myChoiceCDxTech.pdf. Ray-Coquard I, Pautier P, Pignata S, et al; PAOLA-1 Investigators. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379(26):2495-2505. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology Perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014;32(12):1277-1280. Ray-Coquard I, Leary A, Pignata S, et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2023;34(8):681-692. Hardesty MM, Krivak TC, Wright GS, et al. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol. 2022;166(2):219-229. Monk BJ, Oaknin A, O’Malley D et al. ATHENA-COMBO, a phase III, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC). Ann Oncol. 2024;35:1223-1224. Ray-Coquard I, Pautier P, Pignata S, et al. Phase III PAOLA-1/ENGOT-ov25: maintenance olaparib with bevacizumab in patients with newly diagnosed, advanced ovarian cancer treated with platinum-based chemotherapy and bevacizumab as standard of care. Presentation LBA2_PR presented at ESMO Annual Conference 2019, 27 September–1 October, Barcelona, Spain. Ray-Coquard I, Pautier P, Pignata S, et al. Supplementary Information. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428.
AE, adverse event; aOC, advanced ovarian cancer; AR, adverse reaction; Bev, bevacizumab; BRCAm, BRCA mutation; BRCAwt, BRCA wildtype; BID, twice daily; CDx, companion diagnostic; CI, confidence interval; eCRF, electronic case report form; gBRCAm, germline BRCA mutation; HR, hazard ratio; HRD, homologous recombination deficiency; ITC, indirect treatment comparison; ITT, intent-to-treat; IV, intravenous; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; OS, overall survival; PARP, poly (ADP-ribose) polymerase; PFS, progression-free survival; PO, orally; RECIST, Response Evaluation Criteria In Solid Tumors; Q3W, every 3 weeks; QoL, quality of life; UTI, urinary tract infection.
Design of SOLO-1 trial1,6
In SOLO-16: All patients had a germline or somatic BRCA1 or BRCA2 mutation Patients with stage III disease underwent surgery, either before (upfront) or during (interval) chemotherapy; patients with stage IV disease may not have undergone surgery Intravenous (IV) platinum-based chemotherapy No prior bevacizumab use LYNPARZA, after chemotherapy, for up to 24 months total6
Click on the buttons below to see details of the two trials.
In PAOLA-15: Patients were eligible regardless of BRCA mutation or HRD status5 Some patients underwent surgery, either before (upfront) or during (interval) chemotherapy5 Intravenous (IV) platinum plus taxane chemotherapy5 IV bevacizumab, during and after chemotherapy, for 15 months total5 Olaparib, after chemotherapy, for 24 months total5
Design of PAOLA-1 trial1,5
Prespecified Exploratory Endpoint: OS in the HRD-Positive Subgroup
Prespecified exploratory analysis of the secondary endpoint overall survival (OS) in the HRD-positive*† subgroup showed a clinically meaningful survival benefit after response to first-line platinum-based chemotherapy.7,8‡ Median OS was ~6.3 years (75.2 months) with LYNPARZA plus bevacizumab vs ~4.8 years (57.3 months) with bevacizumab plus placebo8 38% reduction in the risk of death; HR=0.62 (95% CI: 0.45–0.85) Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 5 years.8 LYNPARZA in combination with bevacizumab is the only maintenance combination therapy to demonstrate a clinically meaningful improvement in OS outcomes in patients with HRD-positive disease after response to first-line platinum-based chemotherapy.†
*Select patients for this indication based on an FDA-approved companion diagnostic for LYNPARZA. †Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.4,5 ‡Secondary endpoint: Prespecified exploratory analysis of OS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 5 years.8 §Bevacizumab was administered for a total of up to 15 months, including the period given with chemotherapy and given as maintenance.5 ||LYNPARZA was continued for up to 2 years or until progression of the underlying disease or unacceptable toxicity. Patients, who in the opinion of the treating physician could derive further benefit from continuous treatment, could be treated beyond 2 years.1 ¶Patients with a complete response should stop treatment at 2 years. Patients with evidence of disease at 2 years can remain on therapy at physician discretion.1 In PAOLA-1, it was unknown how many HRD-positive patients remained on therapy longer than 2 years; therefore, results should be interpreted with caution.
OS in the HRD-positive subgroup1,8
PAOLA-1 efficacy results
PAOLA-1 safety
Guideline recommendations
Patients with germline BRCA-mutated disease
Patients with low-risk disease (eg, stage III with optimal debulking)
Patients with controlled hypertension
I would consider LYNPARZA plus bevacizumab in all these patients
I am unlikely to consider LYNPARZA plus bevacizumab in any of these patients
Why Test for HRD?
HRD in Ovarian Cancer
HRD/BRCA Tests Available
Why test for homologous recombination deficiency (HRD) in advanced ovarian cancer?
Ovarian cancer is the most common cause of death among gynecologic cancers.1 Newly diagnosed advanced ovarian cancer is treated with curative intent using cytoreductive surgery and systemic therapy. The first line is likely to be the best setting for treatments to help prevent recurrence.2,3 HRD testing is critical to inform treatment eligibility in patients with advanced ovarian cancer.4 Many patients with ovarian cancer are not tested for BRCA mutations or HRD5 In a retrospective study of biomarker testing in 1002 patients with epithelial ovarian cancer drawn from community health systems in the US (2018–2020), 74.7% (748/1002) underwent testing.5 Upfront testing for HRD, prior to initiation of primary therapy, can identify patients who are eligible for LYNPARZA plus bevacizumab maintenance therapy.4
What is HRD?
The homologous recombination repair (HRR) pathway repairs double-strand breaks in DNA.6 Defects in the HRR pathway lead to HRD, the inability to accurately repair double-strand DNA breaks.6 About half of high-grade serous ovarian cancers exhibit HRD.7
BRCA/HRD status of patients with high-grade serous ovarian cancer.7,8
HRD+/BRCAwt
sBRCAm
gBRCAm
Learn more about patients eligible for LYNPARZA plus bevacizumab
Germline testing is conducted on blood samples, whereas somatic and HRD testings are conducted on samples of tumor tissue, and ideally at diagnosis.9,10,12
Sample types for biomarker testing
Test type
Tumor
Germline
Sample
Fresh/frozen sample or archived FFPE specimen10
Blood10
Clinical relevance
Determines total mutation status (somatic + germline)10 May be used to assess genomic instability11 May inform magnitude of benefit of PARP inhibitor therapy13 Tumor testing for BRCA mutations and HRD including genomic instability tests identifies more patients than testing for germline BRCA mutations alone.7,8
May have familial implications14 Informs maintenance therapy13
Limitations
Samples can contain both malignant and normal cells; low cancer cell content can affect results10,11 Does not distinguish between somatic and germline mutations10
Does not identify somatic mutations10
FFPE, formalin-fixed, paraffin-embedded; PARP, poly (ADP ribose) polymerase.
HRD/BRCA Tests Available in Ovarian Cancer
HRD and BRCA companion diagnostic (CDx) tests available for advanced ovarian cancer are shown in the Table.
HRD and BRCA CDx tests in ovarian cancer15-19
Test (company)*
Sample type
gBRCA test†
Tumor BRCA test‡
HRD test
Approved as CDx in advanced ovarian cancer for?
BRACAnalysis CDx® (Myriad Genetics)
Whole blood
<14 days
LYNPARZA® (olaparib) gBRCA Zejula® (niraparib) gBRCA
MyChoice® CDx (Myriad Genetics)
FFPE tumor specimen
≤14 days
LYNPARZA® (olaparib) tumor BRCA and HRD
FoundationOne® CDx (Foundation Medicine)
≤12 days
LYNPARZA® (olaparib) tumor BRCA
BRCAm, BRCA mutation; CDx, companion diagnostic; FFPE, formalin-fixed, paraffin-embedded; gBRCA, germline BRCA; HRD, homologous recombination deficiency. *CDx tests only; not an exhaustive list of available tests. †Detects germline BRCA mutations only; does not detect somatic mutations or HRD. ‡Tumor BRCA tests do not distinguish between germline and somatic BRCAm.
Maximize identification of patients eligible for LYNPARZA plus bevacizumab by using Myriad MyChoice, an FDA-approved HRD test that measures both BRCA mutations and genomic instability.4,17
HRD Testing
HRD Testing in Ovarian Cancer Infographic
HRD Testing E-Learning Module
Dr Ramez Eskander explains the importance of germline and tumor testing.
“I test everybody. I do it concurrently.”
Dr John Chan describes the take home message about genetic testing in women with ovarian cancer.
“All women should be tested.”
American Cancer Society (ACS). Cancer Facts & Figures 2025. Atlanta, GA; 2025. Accessed August 28, 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf Ray-Coquard I, Leary A, Pignata S, et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2023;34(8):681-692. Lorusso D, Mouret-Reynier M-A, Harter P, et al. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-OV25 trial. Int J Gynecol Cancer. 2024;34(4):550-558. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. Matsuno RK, Williams AFO, Sweetnam C, et al. Patterns of homologous repair deficiency and BRCA1/2 testing of ovarian and breast cancers: A real-world study of patients in community health settings in the United States. JCO Oncol Adv. 2025;2(1):e2400079. O’Connor MJ. Targeting the DNA damage response in cancer. Mol Cell. 2015;60(4):547-560. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov. 2015;5(11):1137-1154. Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2014;20(3):764-775. González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848. Capoluongo E, Ellison G, López-Guerrero JA, et al. Guidance statement on BRCA1/2 tumor testing in ovarian cancer patients. Semin Oncol. 2017;44(3):187-197. Miller RE, Leary A, Scott CL, et al. ESMO recommendations on predictive biomarker testing for homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020;31(12):1606-1622. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO guideline update. J Clin Oncol. 2025;43(7):868-891. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 27, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Konstantinopoulos PA, Norquist B, Lacchetti C, et al. Germline and somatic tumor testing in epithelial ovarian cancer: ASCO guideline. J Clin Oncol. 2020;38(11):1222-1245. Myriad Genetic Laboratories, Inc. Myriad BRACAnalysis CDx® Technical Information. Accessed July 2, 2025. https://myriad-library.s3.amazonaws.com/technical-specifications/BRACAnalysis_CDx_Tech_Specs.pdf Myriad Genetic Laboratories, Inc. BRACAnalysis CDx® Germline Companion Diagnostic Test. Accessed August 27, 2025. myriad.com/genetic-tests/bracanalysiscdx-germline-test/ Myriad Genetic Laboratories, Inc. Myriad MyChoice® CDx Technical Information. Accessed June 30, 2025. https://s3.amazonaws.com/myriad-web/myChoiceCDx/downloads/myChoiceCDxTech.pdf. Tan H, Hosein PJ. Detection and therapeutic implications of homologous recombination repair deficiency in pancreatic cancer: A narrative review. J Gastrointest Oncol. 2023;14(05):2249-2259. Foundation Medicine. FoundationOne® CDx Technical Information. RAL-0003_v31. Cambridge, MA:2025.
BRCAm, BRCA mutation; CDx, companion diagnostic; FFPE, formalin-fixed, paraffin-embedded; gBRCAm, germline BRCA mutation; HRD, homologous recombination deficiency; HRD+, homologous recombination deficiency-positive; HRD–, homologous recombination deficiency-negative; HRR, homologous recombination repair; LOH, loss of heterozygosity; LST, large-scale transitions; NCCN, National Comprehensive Cancer Network® (NCCN®); PARP, poly (ADP-ribose) polymerase; sBRCAm, somatic BRCA mutation; TAI, telomeric allelic imbalance.
Germline and tumor testing should be initiated as early as possible, prior to treatment initiation.9
About 18% of women have a germline BRCA mutation, that can be identified by a germline test of a blood sample.8,10
All patients with BRCA mutations have HRD, but not all patients with HRD have BRCA mutations.11
About 25% of women have tumor BRCA mutation (either germline or somatic), that can be identified by a test of tumor tissue.8,10
HRD tests, conducted on tumor tissue, include tests for11: BRCA mutations Genomic instability biomarkers, such as: Loss of heterozygosity (LOH) Large-scale transitions (LST) Telomeric allelic imbalance (TAI) About 50% of patients will test positive for HRD.7 Testing for HRD including genomic instability tests identifies more patients than testing for BRCA mutations alone.7,8 Testing for BRCA mutations alone will miss half of all patients with HRD.7,8
HRD Testing and Treatment Guidelines in Advanced Ovarian Cancer
Treatment Guidelines
Key treatment guidelines recommend HRD and BRCA mutation testing in patients with advanced ovarian cancer. Testing should be performed at diagnosis.1-5
Select buttons to learn more about HRD and BRCA mutation testing guidelines.
National Comprehensive Cancer Network® (NCCN®)
ASCO
SGO
Whom to Test? All patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer should have genetic risk evaluation and germline and somatic testing (if not previously done).1
What to Test? Germline testing: BRCA1 and BRCA2 status should be tested.1 Tumor testing: In the up-front setting, choice of somatic testing should, at a minimum, optimize identification of molecular alterations that can inform use of interventions that have demonstrated benefit in this setting, including BRCA1 and BRCA2, loss of heterozygosity, or HRD status in the absence of a germline BRCA mutation.1 In the absence of BRCA1/2 status, HRD status may provide information on the magnitude of benefit of PARP inhibitor therapy.1
When to Test? Upon pathologic confirmation of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, patients should be referred for a genetic risk evaluation and germline and somatic testing (if not previously done).1
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
NCCN ovarian cancer biomarker testing recommendations1
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer, including Fallopian Tube Cancer and Primary Peritoneal Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed July 28, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. BRCA1/2m, BRCA1 or BRCA2 mutation; HRD, homologous recombination deficiency; PARPi, poly (ADP-ribose) polymerase inhibitor.
Summary of testing guidelines1-5
Guideline
Whom to test
What to test
When to test
NCCN
All patients with OC, FTC, or PPC (germline/somatic) Patients with absence of BRCA1/2 mutation (HRD)
Germline and somatic BRCA1 and BRCA2 in all patients HRD in absence of BRCA1/2 mutation
Upon pathologic confirmation of OC, FTC, or PPC
All patients with epithelial OC (germline) Patients without germline BRCA variant (somatic/HRD)
Germline BRCA1, BRCA2 and other OC susceptibility genes in all patients Somatic BRCA1, BRCA2 including HRD in patients without germline BRCA variant
At diagnosis or as soon as is feasibly possible
All patients with epithelial OC (germline) Patients with negative germline BRCA (somatic/HRD)
Germline testing in all patients Somatic BRCA1/2, LOH and HRD in patients with negative germline BRCA
At diagnosis
ASCO, American Society of Clinical Oncology; FTC, fallopian tube cancer; HRD, homologous recombination deficiency; LOH, loss of heterozygosity; NCCN, National Comprehensive Cancer Network; OC, ovarian cancer; PPC, primary peritoneal cancer; SGO, Society of Gynecologic Oncology. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Treatment guidelines recommend olaparib in combination with bevacizumab1,2,4,6
Treatment guidelines recommend the combination of olaparib plus bevacizumab as first-line maintenance therapy as a treatment option in selected patients with advanced ovarian cancer in complete or partial response to first-line therapy, depending on biomarker status.1,2,4,6
Treatment Guideline Recommendations for olaparib plus Bevacizumab
BRCAm
Notes
NCCN1
NCCN Category 1* recommendation, only in patients that received bevacizumab as part of primary therapy.
ASCO4,6
Olaparib in combination with bevacizumab is the ONLY PARP inhibitor with an NCCN Category 1* recommendation as a treatment option for first-line maintenance treatment in HRD-positive advanced ovarian cancer in patients who received bevacizumab as part of primary therapy.1
NCCN Guidelines recommendations for olaparib plus bevacizumab as post-primary maintenance therapy
BRCA1/2m, BRCA1/2 mutation; BRCA1/2wt, BRCA1/2 wild-type; CR, complete response; g/s, germline or somatic; HR, homologous recombination; HRP, homologous recombination proficient; PARP, poly (ADP-ribose) polymerase; PR, partial response. aNo definitive evidence of disease. bIn the absence of a BRCA1/2 mutation, HRD status may provide information on the magnitude of benefit of PARP inhibitor therapy. cSee Principles of Systemic Therapy (OV-C) and Management of Drug Reactions (OV-D), NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer (including Fallopian Tube Cancer and Primary Peritoneal Cancer) V.3.2025. *NCCN Category 1: Based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate. Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer V.3.2025. © 2025 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 27, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848. Konstantinopoulos PA, Norquist B, Lacchetti C, et al. Germline and somatic tumor testing in epithelial ovarian cancer: ASCO guideline. J Clin Oncol. 2020;38(11):1222-1245. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO guideline update. J Clin Oncol. 2025;43(7):868-891. Gressel GM, Frey MK, Norquist B, Senter L, Blank SV, Urban RR. Germline and somatic testing for ovarian cancer: An SGO clinical practice statement. Gynecol Oncol. 2024;181:170-178. Tew WP, Lacchetti C, Kohn EC. PARP inhibitors in the management of ovarian cancer: ASCO guideline rapid recommendation update. J Clin Oncol. 2022;40(33):3878-3881.
ASCO, American Society of Clinical Oncology; BRCAm, BRCA mutation; BRCAwt, BRCA wildtype; ESMO, European Society for Medical Oncology; HRD, homologous recombination deficiency; HRD+, homologous recombination deficiency-positive; HRD–, homologous recombination deficiency-negative; NCCN, National Comprehensive Cancer Network® (NCCN®); PARP, poly(ADP ribose) polymerase; PARPi, poly(ADP ribose) polymerase inhibitor; SGO, Society of Gynecologic Oncology.
Whom to Test? All women diagnosed with epithelial ovarian cancer should be offered germline genetic testing irrespective of their clinical features or family cancer history. Somatic tumor testing should be performed in women, who do not carry a germline pathogenic or likely pathogenic BRCA1/2 variant3
What to Test? Germline: BRCA1, BRCA2, and other ovarian cancer susceptibility genes3 Somatic: Somatic tumor testing for BRCA1 and BRCA2 pathogenic or likely pathogenic variants3 HRD: Somatic tumor testing should involve measure(s) of homologous recombination4
When to Test? Testing should occur at the time of diagnosis or as soon as feasibly possible4
Whom to Test? The SGO recommends universal germline genetic assessment for all those diagnosed with epithelial ovarian cancer.5
What to Test? For patients undergoing upfront treatment for ovarian cancer with negative germline genetic testing, somatic tumor testing should, at a minimum, include BRCA1/2 somatic variants, LOH, and HRD status as these findings can guide the use of PARP inhibitor maintenance therapy.5
When to Test? Test all patients at the time of disease diagnosis; with 2 possible approaches5 Approach 1: Order somatic tumor testing for HRD with germline BRCA testing Approach 2: Order somatic tumor testing for HRD for patients with negative germline BRCA testing
SGO ovarian cancer biomarker testing recommendations5
Why is advanced ovarian cancer considered a serious disease?
What are the real-world HRD testing rates in advanced ovarian cancer?
Why is HRD testing critical to optimizing outcomes in patients with advanced ovarian cancer?
Why is it important that testing for HRD in advanced ovarian cancer occur at diagnosis or as soon as possible afterwards?
Do treatment guidelines support the use of LYNPARZA in combination with bevacizumab therapy in advanced ovarian cancer?
What evidence supports the use of first-line combination maintenance therapy in patients with advanced ovarian cancer?
What type of patient should receive this combination?
What were the PFS results of the PAOLA-1 trial?
Why are the overall survival (OS) data of the PAOLA-1 trial crucial to our understanding of advanced ovarian cancer treatment?
What do the safety results from the PAOLA-1 trial tell us about the tolerability of this maintenance regimen?
What do HRD tests measure?
Q:
A:
Because women with advanced ovarian cancer are at risk of relapse.1,2 Ovarian cancer is the most common cause of death among gynecologic cancers in the US3 Most patients respond to first-line surgery and platinum-based chemotherapy; however, in the absence of maintenance therapy, 70% of patients relapse within 3 years1,2 Relapsed ovarian cancer is considered incurable and most patients will die from the disease;4,5 Therefore, the first line is likely to be the best setting for treatments to help prevent recurrence4,6
WHY THIS MATTERS:
An understanding of the high recurrence rate in advanced ovarian cancer is critical to optimizing care and should drive every clinical decision after diagnosis to help delay recurrence and potentially extend survival. A biomarker-driven treatment approach is an option recommended by guidelines to personalize therapy and improve long-term outcomes.1,7,8
In a retrospective study of biomarker testing in 1002 patients with epithelial ovarian cancer drawn from community health systems in the US (2018–2020), 74.7% (748/1002) underwent testing, and only 32.8% (245/747) of those tested were tested for BRCA mutations and a genomic instability biomarker (eg, LOH, GIS).9
Biomarker testing can help identify patients who may benefit from PARP inhibitor maintenance therapy regimens.10,11 With suboptimal testing rates, many patients may be missing the opportunity for targeted therapy.9
Early identification of HRD status can allow for the personalization of first-line therapy, helping identify patients who may benefit from PARP inhibitor maintenance therapy regimens.10,11 Patients with HRD-positive disease who receive PARP inhibitor-based maintenance therapy regimens can experience delayed time to recurrence12 Following the first relapse, each subsequent line of therapy is characterized by shorter treatment-free intervals, and cumulative toxicity13-15
Recurrence rates in advanced ovarian cancer have been demonstrated to be over 70% with most relapses occurring within the first 3 years of diagnosis.2,16
Biomarker testing should occur as soon as possible after diagnosis so that biomarker status can inform treatment decisions and allow for determination of a biomarker-driven treatment plan.1,8,17 According to drug indications: Select patients with BRCA mutations are eligible for LYNPARZA monotherapy1,8,12 Select patients with HRD-positive disease, who are eligible for LYNPARZA plus bevacizumab1,8,12
Upfront biomarker testing can help identify patients who may benefit from first-line PARP inhibitor maintenance therapy regimens.10,11
Do treatment guidelines support the use of olaparib in combination with bevacizumab therapy in advanced ovarian cancer?
Treatment guidelines (including National Comprehensive Cancer Network® (NCCN®) and ASCO) recommend the combination of olaparib plus bevacizumab as first-line maintenance therapy option in selected patients with HRD-positive advanced ovarian cancer in complete or partial response to first-line platinum-based therapy.1,7,8 Olaparib in combination with bevacizumab is the ONLY PARP inhibitor option with an NCCN Category 1* recommendation for first-line maintenance treatment in HRD-positive advanced ovarian cancer, in patients who received bevacizumab as part of primary therapy.7 *NCCN Category 1: Based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.7 NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Within the ovarian cancer setting, guidelines support a precision medicine approach: Clinical practice guidelines support germline and tumor testing in all patients with ovarian cancer at diagnosis.1,7,8,17 Clinical practice guidelines recommend maintenance therapy as an option for select patients with advanced ovarian cancer after response to first-line treatment. Treatment determination can be based on biomarker status and prior bevacizumab use.1,7,8 Clinical practice guidelines recommended olaparib in combination with bevacizumab as an option in select patients with HRD-positive disease based on the results of the PAOLA-1 trial.1,7,8,12
The results of the PAOLA-1 clinical trial of LYNPARZA plus bevacizumab support the combination as a treatment for patients with HRD-positive* advanced ovarian cancer after response to first-line platinum-based chemotherapy12 *Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.11,18
The results of PAOLA-1 demonstrate that a personalized biomarker-driven approach should be leveraged to help delay recurrence in patients with HRD-positive disease.
The ideal patient profile includes the following key characteristics: Newly diagnosed, advanced ovarian cancer (stage III–IV)18 HRD-positive tumor (including BRCA-mutated and non-BRCA, HRD-positive)12 In partial or complete response after completion of first-line chemotherapy plus bevacizumab18 A more thorough breakdown includes: 1. Newly diagnosed, advanced disease Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer18 Histology: High-grade serous, high-grade endometrioid, or other epithelial non-mucinous ovarian cancer in patients with a deleterious germline BRCA mutation18 International Federation of Gynecology and Obstetrics (FIGO) stage III or IV18 Completed first-line therapy, including platinum-based chemotherapy plus bevacizumab18 2. In response to first-line platinum-based chemotherapy Partial or complete response or no evidence of disease18 No evidence of disease progression (physical examination, imaging, or CA-125) throughout and after first-line treatment18 3. HRD-positive status HRD-positive tumors are defined as11,12: Deleterious or suspected deleterious BRCA1/2 mutations (germline or somatic), or Non-BRCA HRD-positive, identified by positive genomic instability score; in PAOLA-1, positive was defined as Myriad MyChoice® CDx genomic instability score ≥42 after response to 1L platinum-based chemotherapy18 4. Bevacizumab eligibility Able to tolerate bevacizumab No conditions such as uncontrolled hypertension, recent major surgery or bleeding risk, grade 3–4 hemorrhage, history of gastrointestinal perforation, or fistula19 5. Patients not suitable for maintenance therapy with LYNPARZA and bevacizumab include patients with: Platinum-refractory disease (progression during first-line chemotherapy)18 HRD-negative disease12 Comorbidities and conditions that render a patient unsuitable for bevacizumab therapy, such as uncontrolled hypertension, gastrointestinal perforation, and fistulae19
Identifying the appropriate patient for maintenance therapy is critical to optimizing long-term outcomes as it supports identification of patients who are likely to derive the most benefit. However, the main key to patient identification is biomarker testing, which can predict likelihood of sensitivity to PARP inhibitor therapy.
The PAOLA-1 trial confirmed that LYNPARZA in combination with bevacizumab maintenance therapy improves PFS over placebo plus bevacizumab, establishing this regimen as a maintenance therapy option for patients with HRD-positive* advanced ovarian cancer after response to 1L platinum-based chemotherapy. PAOLA-1 studied LYNPARZA plus bevacizumab vs an active comparator (bevacizumab plus placebo) as maintenance therapy in advanced ovarian cancer18 A prespecified exploratory subgroup analysis showed clinically meaningful PFS benefit in HRD-positive* (including tumor BRCA-mutated) patients after response to first-line chemotherapy.† FDA approval was based on this prespecified exploratory HRD-positive subgroup12,18,20 Median PFS was 3.1 years (37.2 months) with LYNPARZA plus bevacizumab vs ~1.5 years (17.7 months) with bevacizumab plus placebo18 67% risk reduction of disease progression or death; HR=0.33 (95% CI 0.25–0.45)18 Data were based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-118 In a prespecified exploratory analysis of HRD-negative and HRD-unknown patients, there was insufficient evidence to suggest differential efficacy between the combination of LYNPARZA plus bevacizumab and bevacizumab plus placebo1 *Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.11,18 †Secondary endpoint: Prespecified exploratory analysis of PFS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 5 years.6
These results support HRD testing to identify which patients are most likely to benefit and reinforce why HRD testing is critical for treatment decisions.12
The OS data provide evidence of survival in a cancer with a high recurrence rate. Prespecified exploratory analysis of the secondary endpoint overall survival (OS) in the HRD-positive* subgroup showed a clinically meaningful survival benefit after response to first-line chemotherapy†6,20 Median OS was 6.3 years (75.2 months) with LYNPARZA plus bevacizumab vs ~4.8 years (57.3 months) with bevacizumab plus placebo6 38% reduction in the risk of death; HR=0.62 (95% CI 0.45–0.85) Data was based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-16 In a prespecified exploratory analysis of HRD-negative and HRD-unknown patients, there was insufficient evidence to suggest differential efficacy between the combination of LYNPARZA plus bevacizumab and bevacizumab plus placebo18 *Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.11,18 †Secondary endpoint: Prespecified exploratory analysis of OS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 5 years.6
LYNPARZA in combination with bevacizumab is the only maintenance combination therapy to demonstrate a clinically meaningful improvement in OS outcomes in patients with HRD-positive disease.6,20-22 The data demonstrate that maintenance therapy may extend survival.12
The safety results from the PAOLA-1 trial demonstrated that the toxicity profile was consistent with the known adverse effects of each drug and that no new safety signals or unexpected toxicity arose. Common adverse reactions (ARs) with LYNPARZA were generally consistent with the known safety profile of LYNPARZA monotherapy12 ARs and laboratory abnormalities from the primary analysis in PAOLA-1 were mostly Grades 1 and 212 Primary analysis: Fatal adverse reactions occurred in 1 patient due to concurrent pneumonia and aplastic anemia. Serious adverse reactions occurred in 31% of patients who received LYNPARZA plus bevacizumab. Serious adverse reactions in >5% of patients included hypertension (19%) and anemia (17%)12 In addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA plus bevacizumab (5%) than in those receiving placebo plus bevacizumab (1.9%)12 At 5-year follow-up analysis: No new safety signals were identified6 The incidence of MDS/AML/AA was 1.7% (9/535) in the LYNPARZA plus bevacizumab group and 2.2% (6/267) in the bevacizumab plus placebo group6 In the HRD-positive subgroup, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA plus bevacizumab and 2.3% (3/131) in patients who received bevacizumab plus placebo12 22 (4.1%) new primary malignancy events occurred in the LYNPARZA plus bevacizumab group and 8 (3.0%) events occurred in the bevacizumab plus placebo group6 7 (1.3%) pneumonitis events occurred in the LYNPARZA plus bevacizumab group and 2 (0.7%) events occurred in the bevacizumab plus placebo group6
HRD tests combine BRCA mutation analysis and assessments of genomic instability. About half of high-grade serous ovarian cancers exhibit HRD23,24 All patients with BRCA mutations have HRD, but not all patients with HRD have BRCA mutations25 HRD tests, conducted on tumor tissue, include tests for:25 BRCA mutations Genomic instability biomarkers
Testing for BRCA mutations alone will miss half of all patients who are HRD-positive.23,24 Guidelines recommend HRD testing in the absence of BRCA mutations at diagnosis as an option to guide treatment decisions in advanced ovarian cancer.1,7,8,17
González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848. Caruso G, Tomao F, Parma G, et al. Poly (ADP-ribose) polymerase inhibitors (PARPi) in ovarian cancer: Lessons learned and future directions. Int J Gynecol Cancer. 2023;33(4):431-443. American Cancer Society (ACS). Cancer Facts & Figures 2025. Atlanta, GA;2025. Accessed August 28, 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf Lorusso D, Mouret-Reynier M-A, Harter P, et al. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-OV25 trial. Int J Gynecol Cancer. 2024;34(4):550-558. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379(26):2495-2505. Ray-Coquard I, Leary A, Pignata S, et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2023;34(8):681-692. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 27, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO guideline update. J Clin Oncol. 2025;43(7):868-891. Matsuno RK, Williams AFO, Sweetnam C, et al. Patterns of homologous repair deficiency and BRCA1/2 testing of ovarian and breast cancers: A real-world study of patients in community health settings in the United States. JCO Oncol Adv. 2025;2(1):e2400079. Myriad Genetic Laboratories, Inc. Myriad BRACAnalysis CDx® Technical Information. Accessed July 2, 2025. https://myriad-library.s3.amazonaws.com/technical-specifications/BRACAnalysis_CDx_Tech_Specs.pdf Myriad Genetic Laboratories, Inc. Myriad MyChoice® CDx Technical Information. Accessed June 30, 2025. https://s3.amazonaws.com/myriad-web/myChoiceCDx/downloads/myChoiceCDxTech.pdf LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. Eng KH, Hanlon BM, Bradley WH, Szender JB. Prognostic factors modifying the treatment-free interval in recurrent ovarian cancer. Gynecol Oncol. 2015;139(2):228-235. Lutgendorf SK, Shinn E, Carter J, et al. Quality of life among long-term survivors of advanced stage ovarian cancer: A cross-sectional approach. Gynecol Oncol. 2017;146(1): 101-108. Dunton CJ. Management of treatment-related toxicity in advanced ovarian cancer. Oncologist. 2002;7(S5):11-19. Ovarian Cancer Research Alliance. Recurrence. Accessed August 27, 2025. https://ocrahope.org/patients/about-ovarian-cancer/recurrence/ Gressel GM, Frey MK, Norquist B, Senter L, Blank SV, Urban RR. Germline and somatic testing for ovarian cancer: An SGO clinical practice statement. Gynecol Oncol. 2024;181: 170-178. Ray-Coquard I, Pautier P, Pignata S, et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428. Avastin® (bevacizumab) [prescribing information]. South San Francisco, CA: Genentech, Inc; 2022. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology Perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014;32(12):1277-1280. Hardesty MM, Krivak TC, Wright GS, et al. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol. 2022;166(2):219-229. Monk BJ, Oaknin A, O’Malley D et al. ATHENA-COMBO, a phase III, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC). Ann Oncol. 2024;35:1223-1224. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov. 2015;5(11):1137-1154. Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2014;20(3):764-775. Miller RE, Leary A, Scott CL, et al. ESMO recommendations on predictive biomarker testing for homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020;31(12):1606-1622.
AR, adverse reaction; ASCO, American Society of Clinical Oncology; CA-125, cancer antigen 125; CDx, companion diagnostic; ESMO, European Society for Medical Oncology; FAQs, frequently asked questions; FDA, US Food and Drug Administration; FIGO, International Federation of Gynecology and Obstetrics; GIS, genomic instability score; HRD, homologous recombination deficiency; ITT, intent-to-treat; LOH, loss of heterozygosity; LST, large-scale transitions; NCCN, National Comprehensive Cancer Network® (NCCN®); OS, overall survival; PARP, poly (ADP-ribose) polymerase; PFS, progression-free survival; QoL, quality of life; TAI, telomeric allelic imbalance.
Video Resource Library
Video
The Role of Biomarker Testing and Delivering Personalized Care
Grand Rounds: Case Based Approaches
Optimizing Physician and Patient Conversations by Understanding Perspectives
PAOLA-1: A Review of PFS
Redefining Care for Advanced Ovarian Cancer Patients: Clinical Perspectives on the Impact of SOLO-1 and PAOLA-1
