Liso-cel Yields Significant Responses in R/R Mantle Cell Lymphoma

Treatment with lisocabtagene maraleucel (liso-cel; Breyanzi) produced clinically meaningful and statistically significant responses in patients with relapsed or refractory mantle cell lymphoma (MCL) in the phase 1 TRANSCEND NHL 001 trial (NCT02631044) and in those with follicular lymphoma in the phase 2 TRANSCEND FL trial (NCT04245839), according to a press release from Bristol Myers Squibb.

Investigators of the open-label, multi-center, single-arm phase 1 TRANSCEND NHL 001 trial assessed the safety, efficacy, and pharmacokinetics of liso-cel in those with relapsed or refractory B-cell non-Hodgkin lymphoma, including MCL.

In addition to meeting the studies’ primary end points of overall response rate, investigators also reported that both studies met the secondary end point of complete response (CR) rate, as liso-cel elicited high rates of CRs in both MCL and follicular lymphoma. Additionally, liso-cel did not produce any new safety signals in either study.

Investigators plan to complete a full evaluation of the TRANSCEND NHL 001 and TRANSCEND FL trials, present detailed findings from the studies at an upcoming medical meeting, and discuss these data with regulatory health authorities.

“For people living with relapsed or refractory follicular lymphoma or [MCL], there are limited treatment options that provide deep and durable responses, especially for patients with high-risk disease,” Anne Kerber, senior vice president and head of Cell Therapy Development at Bristol Myers Squibb, said in the press release. “We believe these data further confirm [liso-cel’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, [liso-cel], to more patients.”

Investigators of the open-label, multi-center, single-arm phase 1 TRANSCEND NHL 001 trial assessed the safety, efficacy, and pharmacokinetics of liso-cel in those with relapsed or refractory B-cell non-Hodgkin lymphoma, including MCL. Patients received 1 or 2 intravenous injections of liso-cel per cycle.

The primary end points of the TRANSCEND NHL trial included ORR, dose-limiting toxicities, and treatment-related adverse effects (TRAEs). Secondary end points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS), and health-related quality of life.

Patients 18 years and older with relapsed or refractory B-cell non-Hodgkin lymphoma were eligible for enrollment on the TRANSCEND NHL 001 trial. Additional inclusion criteria included having PET-positive disease, archived tumor tissue available from the last relapse, and an ECOG performance status of 0 or 1. Patients also needed to have adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.

Investigators of the global, multi-center, open-label phase 2 TRANSCEND FL trial evaluated the safety and efficacy of liso-cel in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including those with follicular lymphoma. Patients received 30 mg/m² of intravenous fludarabine daily for 3 days plus 300 mg/m² of intravenous cyclophosphamide daily for 3 days prior to infusion with liso-cel. Treatment with liso-cel consisted of a targeted dose of 100 x 10⁶ CAR T cells at 2 to 7 days following completion of chemotherapy.

The primary end point of the TRANSCEND FL trial was ORR. Secondary end points included DOR, PFS, OS, and AEs.

Patients 18 years and older with histologically confirmed grade 1, 2, or 3a relapsed or refractory follicular lymphoma or marginal zone lymphoma were eligible to enroll on the trial. Additional inclusion criteria included having an ECOG performance status of 0 or 1, adequate organ function, and adequate vascular access for leukapheresis.

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. Bristol Myers Squibb. May 1, 2023. Accessed May 1, 2023. bit.ly/3NoRrhF