Bristol Myers Squibb’s cell therapy gets USFDA nod for relapsed or refractory follicular lymphoma

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has granted accelerated approval for 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 follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.*

In relapsed or refractory FL, Breyanzi is delivered as a one-time infusion** with a single dose containing 90 to 110 x 106 CAR-positive viable T cells. 

The Phase 2 TRANSCEND FL study included the largest primary analysis set of patients with relapsed or refractory FL of a clinical trial evaluating a CAR T cell therapy in this patient population. Based on the US Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting and included in the primary efficacy analysis set (n=94), the overall response rate (ORR) was 95.7 per cent (95 per cent CI: 89.5-98.8). ORR was defined as the percentage of patients achieving a partial or complete response per Lugano criteria as assessed by an Independent Review Committee (IRC). The complete response (CR) rate was 73.4 per cent (95 per cent CI: 63.3-82.0) and required a negative bone marrow biopsy for confirmation. Responses were rapid and durable with a median time to response of one month (range: 0.6-3.3) and median duration of response (DOR) not reached (95 per cent CI: 18.04-NR), with 80.9 per cent of responders remaining in response at 12 months, and 77.1 per cent of responders remaining in response at 18 months. Results from the primary analysis of TRANSCEND FL presented at the 2023 International Conference on Malignant Lymphoma showed an ORR of 97 per cent (95 per cent CI: 91.6-99.4; one-sided p<0.0001) in efficacy evaluable patients (n=101), with 94 per cent of patients achieving a CR (95 per cent CI: 87.5-97.8; one-sided p<0.0001).

Breyanzi has exhibited a consistent safety profile and across clinical trials, any grade cytokine release syndrome (CRS) occurred in 53 per cent of patients, including Grade >3 CRS in 4 per cent of patients. The median time to onset was 5 days (range: 1 to 63 days). Any grade neurologic events (NEs) occurred in 31 per cent of patients, with Grade >3 NEs occurring in 10 per cent of patients. The median time to onset of NEs was 8 days (range: 1 to 63 days). The safety profile of Breyanzi allows for the option of outpatient treatment and management of patients. Patients in the TRANSCEND FL study were treated in the inpatient and outpatient setting.

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

**Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring.