Lisocabtagene Maraleucel Showed Statistically Significant Response in Certain R/R Lymphomas

Lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) demonstrated a statistically significant and clinically meaningful response in patients with relapsed or refractory (R/R) follicular lymphoma (FL) and R/R mantle cell lymphoma (MCL), according to topline results from the TRANSCEND FL (NCT04245839) and TRANSCEND NHL 001 (NCT02631044) studies.

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Lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, improves the expansion and persistence of CAR T cells and is the only 1 of its kind to demonstrate clinically meaningful benefit across the broadest array of B-cell malignancies.

“For people living with [R/R] FL or MCL, there are limited treatment options that provide deep and durable responses, especially for patients with high-risk disease,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb, in a press release. “These continued unmet needs coupled with our deep understanding of lymphoma biology drive us to deliver transformative treatments for patients.”

FL makes up 30% of all B-cell non-Hodgkin lymphoma (NHL) cases. It is a slow-growing disease that affects white blood cells in the lymph nodes or organs. Characterized by periods of remission and relapse, it is more difficult to treat after relapse/disease progression. Additionally, MCL is an aggressive and rare type of NHL that occurs more often in male adults in their mid-60s in age. Relapse and disease progression are common after initial treatment.

TRANSCEND NHL 001 is an open-label, multicenter, phase 1, single-arm study evaluating safety, pharmacokinetics, and antitumor activity for patients with R/R B-cell NHL. It had co-primary outcomes of treatment-related adverse events (AEs) and dose-limiting toxicities. TRANSCEND FL is an open-label, global, multicenter, phase 2, single-arm study evaluating efficacy and safety for patients with R/R indolent B-cell NHL, including FL and MCL. It met the key secondary outcome of complete response rate (CRR) in patients with R/RFL and MCL; investigators are evaluating secondary outcomes of duration of response and progression-free survival as well.

Investigators did not report any new safety signals. The most common and serious AEs that occurred in 46% of patients include cytokine release syndrome (CRS), encephalopathy, sepsis, febrile neutropenia, pneumonia, and delirium. Fatal AEs occurred in 4% of patients.

Further, it was recently announced that lisocabtagene maraleucel showed CRR in patients with relapsed or refractory chronic lymphocytic leukemia in the TRANSCEND CLL 004 trial. Results from TRANSCEND FL and TRANSCEND NHL 001 will be presented at an upcoming meeting.

“We believe these data further confirm [lisocabtagene maraleucel’s] best-in-class and best-in-disease profile and underscore the significant progress we are making in bringing the promise of our differentiated CAR T cell therapy, [lisocabtagene maraleucel], to more patients.”

Reference

Bristol Myers Squibb’s TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi(lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma Meet Primary Endpoint of Overall Response Rate. News Release. May 1, 2023. Accessed on May 2, 2023. https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibbs-TRANSCEND-FL-and-TRANSCEND-NHL-001-Studies-of-Breyanzi-lisocabtagene-maraleucelin-Relapsed-or-Refractory-Follicular-Lymphoma-and-Mantle-Cell-Lymphoma-Meet-Primary-Endpoint-of-Overall-Response-Rate/default.aspx