Bristol Myers Squibb has received approval from the European Commission for Breyanzi (lisocabtagene maraleucel; liso-cel), a chimeric antigen receptor (CAR) T cell therapy directed towards CD19, for the treatment of adult patients suffering from diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B). The treatment is intended for patients who have relapsed within 12 months of completion of, or have shown refractory response to, first-line chemoimmunotherapy.
Approval of Breyanzi was granted after the positive results obtained from the Phase 3 TRANSFORM trial, where the therapy exhibited significant and clinically relevant advancements in the primary endpoint of event-free survival (EFS), and in key secondary endpoints such as complete responses (CR) and progression-free survival (PFS) when compared to standard treatment (which involves salvage immunochemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant [HSCT]). The treatment demonstrated a manageable and well-established safety profile.
In the TRANSFORM study, Breyanzi more than quadrupled median EFS compared to standard therapy (10.1 months vs. 2.3 months) at the time of prespecified interim analysis with a median follow-up of 6.2 months. Results of the primary analysis, with a median follow-up of 17.5 months were consistent with the interim analysis, with median EFS not reached for Breyanzi (95% CI: 9.5-NR) vs. 2.4 months for standard therapy (95% CI: 2.2-4.9).
With Breyanzi, the majority (73.9%) of patients achieved a CR compared to less than half (43.5%) of those who were treated with standard therapy. Median PFS was not reached (95% CI: 12.6-NR) with Breyanzi vs. 6.2 months (95% CI: 4.3-8.6) with standard therapy
The safety profile of Breyanzi is well-established, and in the TRANSFORM study, occurrences of cytokine release syndrome (CRS) and neurologic events were generally low-grade, and mostly resolved quickly with standard protocols and without the use of prophylactic steroids.
