Phase II Data: Liso-Cel Overall, Complete Response Rates Favorable in Both MZL, Follicular Lymphoma

Lisocabtagene maraleucel (liso-cel) is a one-time, CD19-directed chimeric antigen receptor (CAR) T-cell injection therapy. It is currently being evaluated in the international, open-label, phase II TRANSCEND FL trial for use in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma. The trial includes evaluation of this therapy in marginal zone lymphoma (MZL) and follicular lymphoma (FL), and its recent data have been favorable in both conditions.

Bristol Myers Squibb, the biopharmaceutical company that markets liso-cel as Breyanzi, announced in a press release that in TRANSCEND FL’s MZL cohort, the CAR T-cell therapy met the trial’s primary endpoint, having produced a statistically significant and clinically meaningful overall response rate (ORR). It also met the trial’s key secondary endpoint for complete response (CR) rate, with a manageable safety profile and no new safety signals observed.¹

“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,” commented Rosanna Ricafort, MD, vice president, head of Late Development Program Leadership, Hematology and Cell Therapy at Bristol Myers Squibb.

In terms of its efficacy and safety in FL, liso-cel demonstrated impressive results in TRANSCEND FL according to data presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, California. These data were specifically related to its use as second-line and third-line or later management of high-risk disease after two years of follow-up.²

Among patients who received the treatment as second-line FL management, with a median on-study follow-up of 29.5 months, the ORR and CR rate were both 95.7%. Patients who received the treatment as third-line or later care, with a median on-study follow-up of 30.0 months, had an ORR of 97.1% and CR rate of 94.2%. The safety profile was manageable and revealed no new safety signals.

“These data support liso-cel as a highly efficacious and safe treatment option for pts [patients] with R/R [relapsed or refractory] FL,” wrote Loretta Nastoupil, MD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues who presented at the ASH Annual Meeting.

Liso-cel currently has FDA-approved indications in FL grade 3B, high-grade B-cell lymphoma, large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and mantle cell lymphoma in adult patients. It has also received accelerated approvals, continuation of which are subject to confirmatory trials, in relapsed or refractory chronic lymphocytic leukemia, FL, and small lymphocytic lymphoma in adults.¹

References

1. Bristol Myers Squibb announces positive topline results for Breyanzi (lisocabtagene maraleucel) in adult patients with relapsed or refractory marginal zone lymphoma. News release. Bristol Myers Squibb. February 10, 2025. Accessed February 10, 2025.
2. Nastoupil L, Dahiya S, Palomba ML, et al. Lisocabtagene maraleucel (liso-cel) in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): Transcend FL 2-year follow-up. Abstract #4387. Presented at the 66th American Society of Hematology Annual Meeting and Exposition; December 7-10, 2024; San Diego, California.