Liso-Cel in MZL, Follicular Lymphoma Produces Favorable Overall, Complete Response Rates

Lisocabtagene maraleucel (liso-cel) is a CD19-directed chimeric antigen receptor (CAR) T-cell injection therapy. The international, open-label, phase II TRANSCEND FL trial is evaluating this treatment for use in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphomas, including marginal zone lymphoma (MZL) and follicular lymphoma (FL). For both conditions the therapy has recently shown favorable results in the trial.

In a press release Bristol Myers Squibb, which markets liso-cel as Breyanzi, announced that in the MZL cohort of TRANSCEND FL liso-cel met the primary trial endpoint, having produced an overall response rate (ORR) that was statistically and clinically significant. It also met the trial’s secondary endpoint regarding complete response (CR) rate, with manageable safety 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,” remarked Rosanna Ricafort, MD, vice president, head of Late Development Program Leadership, Hematology and Cell Therapy at Bristol Myers Squibb.

Liso-cel also demonstrated impressive performance as FL treatment in TRANSCEND FL data presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, California. The findings specifically were in use of the therapy as second-line and third-line or later care for high-risk disease after two years of follow-up.²

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

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

The FDA has approved indications for adult patient liso-cel use in FL grade 3B, high-grade B-cell lymphoma, large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and mantle cell lymphoma. Liso-cel has also received accelerated approvals from the FDA for use in adults with relapsed or refractory chronic lymphocytic leukemia, FL, and small lymphocytic lymphoma. Continuation of these accelerated approvals is subject to results from additional trials.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.