Liso-Cel/Breyanzi Gets Accelerated Approval for Relapsed/Refractory Follicular Lymphoma
The CAR T-cell therapy was also recently approved for treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
Liso-Cel/Breyanzi Gets Accelerated Approval for Relapsed/Refractory Follicular Lymphoma
The FDA has granted accelerated approval to Bristol Myers Squibb’s lisocabtagene maraleucel chimeric antigen receptor (CAR) T-cell therapy for treating adults with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.1
“In the treatment of relapsed or refractory follicular lymphoma, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” study investigator M. Lia Palomba, MD, lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center, said in a statement.2 “The FDA approval of liso-cel for patients with relapsed or refractory FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”
The approval is based off of data from the TRANSCEND FL trial (NCT04245839) that Palomba served as an investigator on. The most recent data from TRANSCEND FL were presented at the 2023 American Society of Hematology (ASH) in December by Franck Morschhauser, MD, PhD, professor, hematology, University of Lille and Hospital Claude Huriez, and chair, Lymphoma Study Association (LYSA).3
The 23 evaluable participants in TRANSCEND FL had a median follow-up of 18.1 months (range, 1.0-26.8) and an overall response rate and complete response rate of 95.7% % (95% CI [78.1–99.9]; 1-sided P < .0001). Median duration of response (DOR) and progression-free survival (PFS) were not reached; 12-month rates were 89.8% and 91.3%, respectively. These participants had a median age of 53 years (range, 34–69), 74% had stage III/IV disease, and 35% had high-risk per FL International Prognostic Index (FLIPI) disease.3
The 101 efficacy evaluable patients with relapsed or refractory FL treated in the third-line plus setting (n=101) had an overall response rate of 97% (95% CI, 91.6-99.4; one-sided P <.0001) and a complete response rate of 94% (95% CI, 87.5-97.8; one-sided P <.0001). The median duration of response was not reached at a median follow-up of 16.6 months and 81.9% of responders had an ongoing response at 12 months. Median progression-free survival (PFS) was also not reached at a median follow-up of 17.5 months and 80.7% of patients had no progression at 12 months.
The 130 participants in the safety set had a median on-study follow-up of 18.9 months. There were no new safety signals observed. Any grade cytokine release syndrome (CRS) occurred in 58% of patients, with Grade 3 CRS occurring in 1% of patients. Any grade neurologic events (NEs) were reported in 15% of patients, with Grade 3 NEs occurring in 2% of patients.
WATCH NOW: Franck Morschhauser, MD, PhD, on Next Steps for Follicular Lymphoma and Liso-Cel
“So far most of the responses are durable and we have a very good overall survival with only 1 patient dying. We need more follow up because the data are not mature bond one year and we should have that next year. But it’s really encouraging,” Morschhauser told CGTLive® at ASH.
Breyanzi was also recently approved for treating chronic lymphocytic leukemia or small lymphocytic lymphoma in March 2024.4 The therapy is also approved for the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL) in the US, Japan, and Europe, and for relapsed and refractory LBCL after 2 or more lines of systemic therapy in Japan, Europe, Switzerland, and Canada.4
REFERENCES
1. FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. News release. FDA. May 15, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma
2. Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma. News release. Bristol Myers Squibb. News release. May 15, 2024. https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibbs-CAR-T-Cell-Therapy-Breyanzi-Approved-by-the-U.S.-Food-and-Drug-Administration-for-Relapsed-or-Refractory-Follicular-Lymphoma/default.aspx
3. Morschhauser F, Dahiya S, Palomba ML, et al. TRANSCEND FL: Phase 2 study primary analysis of lisocabtagene maraleucel as second-line therapy in patients with high-risk relapsed or refractory follicular lymphoma. Presented at: 2023 ASH Annual Meeting & Exposition, December 9-12; San Diego, California. Abstract 602.
4. U.S. FDA Approves Bristol Myers Squibb’s Breyanzi ® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). News release. Bristol Myers Squibb. March 14, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Breyanzi--as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx
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