Bristol Myers Squibb announced the U.S. 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. 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. Historically, FL has been considered an incurable disease, and patients frequently relapse following front-line therapy, with prognosis worsening after each subsequent relapse.

Despite advances in treatment, there remains an unmet need for additional options that offer treatment-free intervals with durable, complete responses. 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 U.S. Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting andincluded in the primary efficacy analysis set (n=94), the overall response rate (ORR) was 95.7% (95% 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% (95% 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% CI: 18.04-NR), with 80.9% of responders remaining in response at 12 months, and 77.1% 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% (95% CI: 91.6-99.4; one-sided p<0.0001) in efficacy evaluable patients (n=101), with 94% of patients achieving a CR (95% 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% of patients, including Grade >3 CRS in 4% of patients. The median time to onset was 5 days (range: 1 to 63 days).

Any grade neurologic events (NEs) occurred in 31% of patients, with Grade >3 NEs occurring in 10% 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. Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provides support that allows for access to therapies, including Breyanzi. Bristol Myers Squibb also supports the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information, manufacturing updates, and patient and caregiver support.