Phase 2 Trial for BMS’s Liso-Cel Meets Primary End Point in R/R Marginal Zone Lymphoma Cohort

Bristol Myers Squibb (BMS)’s phase 2 TRANSCEND FL clinical trial (NCT04245839) evaluating lisocabtagene maraleucel (liso-cel, marketed as Breyanzi), an autologous CD19-directed CAR T-cell therapy, has met its primary end point in its cohort for adult patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL).1

Liso-cel showed a statistically significant and clinically meaningful overall response rate in this cohort, which constituted the criteria for the primary end point. In addition, the cohort also met a key secondary end point for complete response rate. With regard to safety, BMS noted that no new safety signals were observed in the cohort. According to BMS, r/r MZL is the fifth indication for which liso-cel has shown clinically meaningful benefit, making it the CD19-directed CAR-T product that has shown efficacy and manageable safety in the highest number of B-cell malignancies.

“MZL is a slow-growing cancer that, for many, has a favorable prognosis,” Rosanna Ricafort, the vice president and head of Late Development Program Leadership, Hematology and Cell Therapy, at BMS, said in a statement.1 “But for those patients who relapse or become refractory, the disease can be quite aggressive, and there is a need for new effective and tolerable treatment options to address this unmet critical need. We are pleased that the TRANSCEND FL study supports the potential of Breyanzi in marginal zone lymphoma and look forward to presenting detailed results from the study at an upcoming medical meeting.”

The news is the latest in a series of recent positive updates from BMS regarding liso-cel. In January 2025, the company announced that its Type II variation application for liso-cel had received a recommendation for approval in r/r follicular lymphoma (FL) from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).2 Specifically, the recommendation, which was based on data from patients with FL treated in TRANSCEND FL, pertains to a potential indication for adults with r/r FL who have received 2 or more prior lines of systemic therapy.

“As a company at the forefront of advancing therapies that transform outcomes for some of the most difficult-to-treat cancers, CAR T-cell therapies are a significant focus of our research, and Breyanzi remains a cornerstone of our cell therapy portfolio and pipeline,” Anne Kerber, senior vice president, head of Late Clinical Development, Hematology, Oncology and Cell Therapy, at BMS, said in a January 2025 statement.2 “This is another important step in our commitment to delivering Breyanzi to more patients across indications, as well as expanding into new regions, especially for diseases with continued unmet need such as r/r FL, which is considered incurable.”

Late last year, at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, BMS presented 5-year survival data from patients with r/r large B-cell lymphoma (LBCL) who were treated with liso-cel in the TRANSCEND-NHL-001 clinical trial (NCT02631044).3 Shortly after the conference, CGTLive® spoke with Manali Kamdar, MD, the associate professor of medicine–hematology and clinical director of lymphoma services at the University of Colorado, about the key findings from the update.

“The net is that in this study, the median overall survival at the 5 year mark was 27.5 months, the estimated overall survival rate at 5 years was 38%, and the median disease-specific survival was 68 months with an estimated disease-specific survival rate at 5 years of 52%,” Kamdar told CGTLive. “These results underscore the curative potential of liso-cel in patients with r/r LBCL in the third line setting.”

Source:
https://www.cgtlive.com/view/phase-2-trial-bms-liso-cel-meets-primary-end-point-marginal-zone-lymphoma-cohort

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