Bristol Myers Squibb Breyanzi approved by USFDA for adults with Marginal Zone Lymphoma
Princeton: Bristol Myers Squibb has received approval for Breyanzi (lisocabtagene maraleucel; liso-cel) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.
Breyanzi is administered as a one-time infusion.
“The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. “Breyanzi is the first and only CAR T cell therapy approved for this patient population, demonstrating Bristol Myers Squibb’s deep commitment to expanding access and reaching as many patients as possible with this innovative, practice-changing treatment.”
This approval of Breyanzi is based on results from the MZL cohort in TRANSCEND FL, an open-label, multicenter, multi-cohort, single-arm study. Based on the U.S. Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting and included in the primary efficacy analysis set (n=66), the overall response rate (ORR) was 95.5% (95% CI: 87.3-99.1). ORR was defined as the percentage of patients achieving a partial or complete response per the Lugano criteria assessed by an Independent Review Committee (IRC) per CT. The complete response (CR) rate was 62.1% (95% CI: 49.3-73.8). The median duration of response (mDOR) was not reached (95% CI: 25.59-NR), with 90.1% of responders remaining in response at 24 months.
“Patients living with marginal zone lymphoma, a subtype of indolent non-Hodgkin lymphoma, generally see success with initial therapy, but a subset of patients ultimately experience multiple relapses over the course of many years, creating a pressing need for new treatment options with durable outcomes,” said M. Lia Palomba, M.D., TRANSCEND FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “The FDA approval of liso-cel in relapsed or refractory marginal zone lymphoma is a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.”
The safety profile of Breyanzi in R/R MZL was consistent with prior reports from trials in other indications. Patients in the MZL cohort of the TRANSCEND FL study were treated in the inpatient and outpatient setting since the safety profile of Breyanzi allows for the option of outpatient treatment and adverse event management for appropriate patients.
Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy, relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy.
Breyanzi is also approved in Japan, the European Union (EU), Switzerland, Israel, the United Kingdom (UK), and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; in the EU, Switzerland, Israel, and the UK for the treatment of relapsed or refractory FL after two or more lines of systemic therapy; and in the EU and Israel for the treatment of relapsed or refractory MCL after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
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