Lisocabtagene Maraleucel Induces Significant Response in FL and MCL Populations

Article

The TRANSCEND FL and TRANSCEND NHL 001 studies of lisocabtagene maraleucel met its primary end point of overall response rate and secondary end point of complete response rate in patients with follicular lymphoma and B-cell non-Hodgkin lymphoma.

Image Credit © LASZLO - stock.adobe.com

Image Credit © LASZLO [stock.adobe.com]

Treatment with lisocabtagene maraleucel (liso-cel; Breyanzi) led to statistically significant and clinically meaningful responses in the phase 2 TRANSCEND FL study (NCT04245839) of the agent in patients with relapsed/refractory follicular lymphoma (FL), and in the phase 1 TRANSCEND NHL 001 study (NCT02631044) of patients with relapsed/refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma (MCL).1

According to positive topline data from both studies, treatment with lisocabtagene maraleucel met the primary end point of overall response rate (ORR) among both patient populations. The key secondary end point of complete response rate was also met in both studies, demonstrating high rates of complete responses in patients with relapsed or refractory FL and MCL.

Regarding safety, there were no new safety signals reported for liso-celfrom patients with FL or MCL treated in either study. A full evaluation of the TRANSCEND FL and TRANSCEND NHL 001 data, as well as a presentation of detailed results from the 2 studies, are expected to be discussed at an upcoming medical meeting, as well as with health authorities.

“For people living with relapsed or refractory follicular lymphoma or mantle cell lymphoma, 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 the press release. “These continued unmet needs coupled with our deep understanding of lymphoma biology drive us to deliver transformative treatments for patients. We believe these data further confirm [liso-cel] 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.”

TRANSCEND FL is an open-label, global, multicenter, single-arm, phase 2 study where investigators are assessing the efficacy and safety of liso-cel in patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma, including FL and marginal zone lymphoma.

This study is divided into 3 periods, including a pretreatment period which consists of screening assessments, leukapheresis and the pretreatment evaluation, the treatment period which begins with the administration of lymphodepleting (LD) chemotherapy and continues through administration of the agent at day 1 with follow-up through day 29, and a posttreatment period which includes follow-up assessments for disease status and safety for 5 years.2

Those enrolled in the study will be treated with fludarabine via intravenous infusion (IV) at a dose of 30 mg/m2/day for 3 days, along with cyclophosphamide IV at 300 mg/m2/day for 3 days, before receiving prior to lisocabtagene maraleucel. Liso-celwill be given to patients on day 1 at a target dose of 100 × 106 chimeric antigen receptor (CAR)-positive viable T cells, 2 to 7 days after completion of LD chemotherapy.

Enrollment in the trial is open to patients aged 18 years and older with relapsed/refractory FL that is grade 1, 2 or 3a, or marginal zone lymphoma that is histologically confirmed within 6 months of screening, as assessed by local pathology. Patients should have received at least 1 previous therapy, including an anti-CD20 and alkylating agent, have an ECOG performance status of 0 or 1, adequate organ function, and adequate vascular access for leukapheresis procedure.

The primary end point of the study is ORR with secondary end points of complete response rate, duration of response (DOR), and progression-free survival (PFS).1

Then, the open-label, multicenter, pivotal, phase 1 TRANSCEND NHL 001 study aims to determine the safety, pharmacokinetics, and antitumor activity of lisocabtagene maraleucel for the treatment of patients with relapsed/refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, FL grade 3B, and MCL.

Investigators are assessing the primary end points of ORR, dose-limiting toxicities, and treatment-related adverse events, as well as the secondary end points of complete response rate, DOR, and PFS.

Those enrolled in the study will receive each cycle of liso-cel administered as 1 IV injection or 2 IV injections.3

Patients must be 18 years and older with relapsed/refractory B-cell NHL with PET-positive disease by Lugano classification, an ECOG performance status of 0-1, adequate bone marrow, renal, hepatic, pulmonary, and cardiac function, and adequate vascular access for leukapheresis procedure to be included in the study. If a patient has received previous CD19-targeted therapy, they must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy.

In addition to these 2 TRANSCEND trials, the TRANSCEND CLL 004 trial of liso-cel relapsed or refractory chronic lymphocytic leukemia also met its primary end point of complete response rate.1

REFERENCES:
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 2, 2023. https://bit.ly/44okwjp
A study to evaluate the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory indolent B-cell non-hodgkin lymphoma (NHL) (TRANSCEND FL). ClinicalTrials.gov. Updated April 19, 2023. Accessed May 2, 2023. https://clinicaltrials.gov/ct2/show/NCT04245839
Study evaluating the safety and pharmacokinetics of JCAR017 in B-cell non-hodgkin lymphoma (TRANSCEND-NHL-001). ClinicalTrials.gov. Updated March 3, 2023. Accessed May 2, 2023. https://www.clinicaltrials.gov/ct2/show/NCT02631044

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