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Patient Selector
Which of your 3L+ patients could benefit from a different approach to treatment?
Richard
42 years old
Patient with aggressive disease
View profile
Patrick
71 years old
Patient with bulky/ advanced disease
Anna
61 years old
Patient who cycles through treatment
Sam
58 years old
Patient considered eligible for transplant
Marie
64 years old
Patient who doesn’t want ongoing treatment
ELARA: A pivotal, global open-label, multicenter, single-arm phase II trial in adult patients with R/R FL
3L+, third line and beyond. Note: These are hypothetical patients.
Patient Selector Richard's Story Patrick's Story Anna's Story Sam's Story Marie's Story Summary
CAR, chimeric antigen receptor; CD, cluster of differentiation; CRR, complete response rate; DOR, duration of response; FL, follicular lymphoma; HSCT, hematopoietic stem cell transplant; IRC, Independent Review Committee; IV, intravenous; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; r/r, relapsed/refractory. Disease was reassessed prior to infusion for all patients requiring bridging therapy. Infusion was administrated in an inpatient or outpatient setting at investigator discretion. Refractory to ≥2nd line of systemic therapy (including an anti-CD20 antibody and alkylating agent) or relapsed within 6 months after ≥2nd line of therapy or after an autologous HSCT. References: 1. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608. 2. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp.
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1 b
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• ≥18 years of age • FL grade 1, 2, or 3A • Relapsed/refractory disease • No evidence of histological transformation/FL grade 3B • No prior anti-CD19 therapy or allogeneic HSCT
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Primary: CRR by IRC at 3 months (Lugano 2014 classification) Secondary: ORR, DOR, PFS, OS, safety, cellular kinetics
• Lymphodepleting chemotherapy options were: - Fludarabine (25 mg/m IV daily for 3 days) + cyclophosphamide (250 mg/m IV daily for 3 days) - Bendamustine 90 mg/m IV daily for 2 days • KYMRIAH dose range (single IV infusion) was 0.6-6×108 CAR-positive viable T cells • Median infused dose of KYMRIAH was 2.06×108 CAR+ viable T cells
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Key eligibility criteria
Study Treatment
End points
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Patient Story
Richard is a carpenter and leads an active life. He was diagnosed with FL 2 years ago and had grade 2 lymphoma. Richard has been finding treatment challenging because it interferes with his ability to work, and he doesn’t have the energy to play sports. He is worried about the aggressiveness of his disease and is starting to lose hope that any treatment will work.
Richard - 42 years old
Aggressive Disease (POD24)
Patient selector
Richard’s profile
Rethink treatment
Why KYMRIAH?
Treatment History
1L treatment with R-CHOP 2L treatment with R-Benda Treatment considerations
1L, first-line; 2L, second-line; FL, follicular lymphoma; POD24, progression of disease within 24 months; R-Benda, rituximab and bendamustine; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
- Responded well but relapsed after 18 months (POD24)
- Refractory
- Transplant eligible - No comorbidities
Responded well but relapsed after 18 months (POD24)
Refractory
Transplant eligible No comorbidities
Patients with POD24 are often difficult to treat and may benefit from agents other than traditional chemotherapies
POD 24 is commonly identified as the biggest unmet need in FL
Globally, 1 in 5 patients with POD24, like Richard
POD 24 is highly predictive of poor treatment outcomes and prognosis
Patients were excluded due to: loss to follow up (n=46) and death without POD within 2 years of diagnosis (n=12). References: 1. Casulo C et al. J Clin Oncol. 2015;33(23):2516-2522. 2. Lansigan F et al. Cancer Med. 2019;8(1):165-173.
Progression within 2 years of diagnosis in patients treated with R-CHOP was associated with a greater risk of death
5-year overall survival following first-line R-CHOP therapy in patients with newly diagnosed FL (N=588)
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CR, complete response; CRR, complete response rate; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; mAb, monoclonal antibody; NEs, neurological events; PFS, progression-free survival. For CRS, refers to first CRS episode only. References: 1. Fowler NH et al. Nat Med. 2022;28(2):325-332. 2. Casulo C et al. J Clin Oncol. 2015;33(23):2516-2522. 3. Thieblemont C et al. Presented at: 63rd American Society of Hematology Annual Meeting; December 11-14, 2021; Atlanta, GA. Abstract 131. 4. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608. 5. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp. 6. Fowler NH et al. Presented at: 63rd American Society of Hematology Annual Meeting; December 11-14, 2021; Atlanta, GA. Abstract 3533.
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A SINGLE INFUSION OF KYMRIAH MAY BREAK THE CYCLE OF REPEATED TREATMENTS
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Choose KYMRIAH for patients like Richard
The ELARA study enrolled patients with aggressive disease—a difficult-to-treat, high-risk population
Why might KYMRIAH be the right choice for patients like Richard?
63% of patients in the ELARA trial experienced POD24 from the first anti-CD20 mAb-containing therapy
Best response of CR for POD24 subgroup for the ELARA study
of patients with POD24 achieved CR
12-month PFS for POD24 patients (vs 67% for all patients)
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59%
61%
KYMRIAH contains a 4-1BB costimulatory domain responsible for expansion and persistence of KYMRIAH cells KYMRIAH can be administered in the outpatient setting In the ELARA study, 65% (n=11/17) of patients infused in the outpatient setting had POD24
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In the ELARA study, KYMRIAH demonstrated well-characterized safety, with low rates of grade ≥3 CRS and NEs in the first 8 weeks :
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The reported rates of CRS and NEs vary between the 29-month analysis and the USPI due to differences in the criteria and clinical manifestations by which they are defined The 29-month analysis (ASH 2022) reported serious neurological adverse events, which included ICANS, encephalopathy, dyskinesia, muscular weakness, and tremor, but excluded headaches. The most common NE observed with KYMRIAH was headache (25%)
FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; LDH, lactate dehydrogenase; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-Mono, rituximab monotherapy.
1L treatment with R-CHOP 2L treatment with R-Mono Treatment considerations
Patrick is a retired teacher. He has a large family and enjoys spending time with his grandchildren. He was diagnosed with FL 5 years ago and has grade 3 lymphoma with bulky disease (>7 cm). More than 5 nodal sites, elevated LDH = High risk (FLIPI 4) Symptomatic splenomegaly
Patrick - 71 years old
Bulky/Advanced Disease
Patrick’s profile
Responded well but FL relapsed after 3 years
Responded well but FL relapsed after 9 months
Transplant ineligible
EFS, event-free survival. References: 1. Ghielmini M et al. Ann Oncology. 2013;24(3):561-576. 2. Pavanello F et al. Mediterr J Hematol Infect Dis. 2016;8(1):e2016062. 3. Gogia A et al. Asian Pac J Cancer Prev. 2017;18(3):681-685. 4. Batlevi CL et al. Blood Cancer J. 2020;10(7):74.
Patients with bulky disease are at greater risk of rapid disease progression and have a poorer prognosis than those without bulky disease - Bulky disease is associated with lower EFS and OS High FLIPI score is associated with progression to advanced-stage disease
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Up to 1 in 5 patients have bulky disease, like Patrick
Patients with bulky disease need treatment that offers a rapid and durable response
High FLIPI score is associated with progression to advanced-stage disease
- Bulky disease is associated with lower EFS and OS
Patients with bulky disease are at greater risk of rapid disease progression and have a poorer prognosis than those without bulky disease
For CRS, refers to first CRS episode only. ICANS, immune effector cell-associated neurotoxicity syndrome. References: 1. Fowler NH et al. Nat Med. 2022;28(2):325-332. 2. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp. 3. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608.
KYMRIAH is a single infusion with a well-characterized safety profile and low rates of grade ≥3 CRS and NEs in the ELARA study The most common adverse reactions (incidence >20%) were CRS, infections-- pathogens unspecified, fatigue, musculoskeletal pain, headache, and diarrhea
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Choose KYMRIAH for patients like Patrick
In the ELARA study:
Bulky disease was defined as 1 nodal or extranodal tumor mass >7 cm in diameter or involvement of 3 or more nodal sites, each of diameter >3 cm
Best response of CR for bulky disease subgroup
of patients with bulky disease achieved CR
67%
Why might KYMRIAH be the right choice for patients like Patrick?
of patients had advanced disease (stage III/IV)
86%
of patients had FLIPI score ≥3
60%
ASCT, autologous stem cell transplant.
Refractory to prior therapy Relapsed following ASCT
Anna is a sales manager at a publishing company. She was diagnosed with FL 4 years ago. She leads an active life and enjoys walking her dogs every day. Anna feels frustrated that she has cycled through several unsuccessful treatments, and she fears she will never achieve remission. She has struggled with toxicities, and her lymphoma has been refractory to traditional chemo/immunotherapies.
Anna - 61 years old
Cycling through treatment
Anna’s profile
1L treatment with R-CHOP 2L treatment with R-Benda 3L treatment with ibritumomab tiuxetan
Elevated LDH levels
Treatment considerations
The chance of treatment success diminishes with every line of therapy
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With traditional therapy, median PFS decreases with each line of therapy
Although FL is typically indolent, patients may cycle through therapies as outcomes continue to decline
Patients can cycle through multiple lines of treatment Survival outcomes decline with every line of therapy Chemo/immunotherapy treatment schedules are intensive and involve multiple IV infusions and daily medication for multiple cycles
4L, fourth line; 5L, fifth line; 6L, sixth line; IV, intravenous. A single-center retrospective cohort study of patients with FL. The most common patterns of treatment were rituximab plus anthracycline (38.5%), rituximab single agent (31.3%), rituximab single agent (22.4%), rituximab plus alkylator (18.2%), rituximab plus alkylator (15.6%), and investigational (22.2%) for 1L to 6L, respectively. References: 1. Batlevi CL et al. Blood Cancer J. 2020;10(7):74. 2. Aliqopa. Prescribing information. Bayer HealthCare Pharmaceuticals Inc. 3. Copiktra. Prescribing information. Secura Bio Inc. 4. Zydelig. Prescribing information. Gilead Sciences Inc. 5. Revlimid. Prescribing information. Celgene Corp. 6. Rituxan. Prescribing information. Genentech Inc.
CRR, complete response rate; ORR, overall response rate; PFS, progression-free survival. References: 1. Fowler NH et al. Nat Med. 2022;28(2):325-332. 2. Thieblemont C et al. Presented at: 63rd American Society of Hematology Annual Meeting; December 11-14, 2021; Atlanta, GA. Abstract 131. 3. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp. 4. Aliqopa. Prescribing information. Bayer HealthCare Pharmaceuticals Inc. 5. Copiktra. Prescribing information. Secura Bio Inc. 6. Zydelig. Prescribing information. Gilead Sciences Inc. 7. Revlimid. Prescribing information. Celgene Corp. 8. Rituxan. Prescribing information. Genentech Inc. 9. Data on file. CCTL019E2202. Novartis Pharmaceuticals Corp; July 2021. 10. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608. 11. Fowler NH et al. Presented at: 63rd American Society of Hematology Annual Meeting; December 11-14, 2021; Atlanta, GA. Abstract 3533.
KYMRIAH can be administered in the outpatient setting In ELARA, 18% (n=17/97) of patients received outpatient infusion of KYMRIAH
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Choose KYMRIAH for patients like Anna
Median nUMBER of prior therapies
73% CRR and 69% 12-month PFS seen in patients who had received ≥3 prior lines of therapy
Why might KYMRIAH be the right choice for patients like Anna?
In the ELARA study, KYMRIAH demonstrated strong response rates, even in heavily pretreated patients
(range, 2-13)
KYMRIAH is a single infusion that may allow patients like Anna to break free from the cycle of repeated treatments 75% of patients in ELARA remained treatment free at 18 months
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The most common adverse reactions (incidence >20%) were CRS, infections-- pathogens unspecified, fatigue, musculoskeletal pain, headache, and diarrhea
R-CVP, rituximab, cyclophosphamide, vincristine, and prednisone.
1L treatment with R-CHOP 2L treatment with R-CVP Treatment considerations
Sam is an architect who lives with his wife and 3 teenaged children. Sam was diagnosed with FL 3 years ago. Sam’s wife made the decision to give up her job to help care for him and take him to his appointments.
Sam - 58 years old
Transplant eligible
Sam’s profile
Responded well but FL relapsed after 36 months
CAR, chimeric antigen receptor. References: 1. Kase AM et al. Clin Case Rep. 2022;10(4):e05572. 2. Cooke L et al. Semin Oncol Nurs. 2009;25(2):139-150. 3. Salles G. Hematology Am Soc Hematol Educ Program. 2020;2020(1):287-294. 4. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp. 5. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608.
Patients with r/r FL who are eligible for autologous stem cell transplantation are also likely to be candidates for CAR-T cell therapy based on patient and disease characteristics When choosing treatment, it is important to consider: - Patient treatment experiences and impact on family - Optimal sequencing of therapies
With KYMRIAH, patients may have:
When choosing a treatment, patient experience matters
A single infusion A treatment with a well-characterized safety profile and established safety guidelines Option for outpatient infusion
USPI, United States Prescribing Information. For CRS, refers to first CRS episode only. References: 1. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp. 2. Fowler NH et al. Presented at: 63rd American Society of Hematology Annual Meeting; December 11-14, 2021; Atlanta, GA. Abstract 3533. 3. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608.
KYMRIAH can be administered in the outpatient setting In ELARA, 18% (n=17/97) of patients received outpatient infusion of KYMRIAH KYMRIAH is a single infusion with a well-characterized safety profile
1,3
Choose KYMRIAH for patients like Sam
KYMRIAH demonstrated low rates of grade ≥3 CRS and NEs in the first 8 weeks of the ELARA study
R , rituximab and lenalidomide.
1L treatment with R-CHOP 2L treatment with R Treatment considerations
Marie is a secretary but has had to take time off work due to her disease. She was diagnosed with FL 4 years ago. Marie struggles with the treatment schedule and associated toxicities and feels like she needs a break from it all. She has experienced fatigue, weakness and breathlessness.
Marie - 64 years old
Treatment reluctant
Marie’s profile
Experienced treatment delays and discontinued after 3 cycles due to adverse events
Discontinued due to adverse events
Transplant eligible, but doesn’t want to undergo ASCT because of the high-dose chemotherapy required
FACT-Lym, Functional Assessment of Cancer Therapy, Lymphoma; HRQOL, health-related quality of life; PR, partial response; QOL, quality of life; SF-36, 36-Item Short Form Health Survey. For CRS, refers to first CRS episode only. References: 1. Fowler NH et al. Presented at: International Conference on Malignant Lymphoma; June 18-22, 2021; Virtual. Abstract 266. 2. Kymriah. Prescribing information. Novartis Pharmaceuticals Corp. 3. Aliqopa. Prescribing information. Bayer HealthCare Pharmaceuticals Inc. 4. Copiktra. Prescribing information. Secura Bio Inc. 5. Zydelig. Prescribing information. Gilead Sciences Inc. 6. Revlimid. Prescribing information. Celgene Corp. 7. Rituxan. Prescribing information. Genentech Inc. 8. Data on file. CCTL019E2202. Novartis Pharmaceuticals Corp; July 2021. 9. Dreyling M et al. Presented at: 64th American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. Abstract 608.
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KYMRIAH is a single infusion that may allow patients to break free from the cycle of indefinite treatment with traditional therapies In ELARA, 75% of patients remained treatment free at 18 months KYMRIAH has a well-characterized safety profile with established guidelines
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Choose KYMRIAH for patients like Marie
Patients reported improvements in mental and physical health following treatment with KYMRIAH At 6 months, patients with a CR or PR reported clinically meaningful improvements in SF-36 components for : - General health - Physical functioning - Role limitation due to physical functioning
Improved quality of life is possible
Why might KYMRIAH be the right choice for patients like Marie?
The statistical significance of this patient-reported QOL study was not evaluated and therefore should be interpreted with caution.
At 9 months, patients reported improvements in HRQOL from baseline :
FACT-Lym is a questionnaire used to assess the QOL of patients with lymphoma. It includes the 27-item FACT-General (FACT-G) and the 15-item lymphoma subscale (Lym S). FACT-G assesses QOL across 4 domains: physical, social/family, emotional, and functional well-being. Lym S assesses response to treatment, lymphoma-associated symptoms, and additional patient concerns. The SF-36 subscales are composed of physical functioning, role limitations because of emotional and physical health problems, physical pain, general health perception, vitality, social functioning, and mental health.
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Summary
CHOOSE KYMRIAH FOR YOUR 3L+ PATIENTS WITH R/R FOLLICULARLYMPHOMA
CONTACT A CERTIFIED KYMRIAH CAR-T TREATMENT CENTER TO DISCUSS YOUR PATIENT’S TREATMENT PLAN
CHOOSE KYMRIAH FOR YOUR 3L+ PATIENTS WITH R/R FOLLICULAR LYMPHOMA
