FDA approves Bristol Myers Squibb’s Breyanzi for relapsed or refractory marginal zone lymphoma
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
The U.S. Food and Drug Administration has granted approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, 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 the first and only CAR T cell therapy approved for this patient population and is administered as a one-time infusion.
This approval of Breyanzi is based on results from the MZL cohort in TRANSCEND FL, an open-label, multicenter, multi-cohort, single-arm study. 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), and 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.
ORR was defined as the percentage of patients achieving a partial or complete response per the Lugano criteria assessed by an Independent Review Committee per CT. TRANSCEND FL is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate, and secondary outcome measures include complete response rate, duration of response, and progression-free survival.
The safety profile of Breyanzi in R/R MZL was consistent with prior reports from trials in other indications. In the MZL cohort of the TRANSCEND FL study, any grade cytokine release syndrome (CRS) occurred in 76% of patients, including Grade ≥3 CRS in 4.5% of patients. Any grade nervous system disorders included headache (21%), tremor (21%), encephalopathy (21%), dizziness (16%), and aphasia (10%), including Grade ≥3 headache (1.5%) and Grade ≥3 encephalopathy (1.5%).
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. The treatment process includes blood collection, CAR T cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.
Marginal zone lymphoma is a subtype of non-Hodgkin lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases.