European Commission Approves Breyanzi for Treatment of Relapsed or Refractory Lymphoma

Bristol Myers Squibb has announced that the European Commission has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with 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) who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. This approval covers all European Union (EU) member states. The approval is based on results from the pivotal Phase 3 TRANSFORM trial.

Key Takeaways:

Breyanzi demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), complete responses (CR), and progression-free survival (PFS) compared to standard therapy in the TRANSFORM study.
Breyanzi more than quadrupled median EFS compared to standard therapy (10.1 months vs 2.3 months) at interim analysis.
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 vs 2.4 months for standard therapy.
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.
The safety profile of Breyanzi is well-established, with low-grade cytokine release syndrome (CRS) and neurologic events, which were mostly resolved quickly with standard protocols.
CRS was reported in less than half of patients (48.9%), with Grade 3 CRS reported in 1% of patients.
Neurologic events were reported in 10.9% of patients, with Grade 3 neurologic events reported in 4.3% of patients.

Statistics:

10.1 months: median EFS for Breyanzi at interim analysis.
2.3 months: median EFS for standard therapy at interim analysis.
17.5 months: median follow-up for primary analysis of Breyanzi.
2.4 months: median EFS for standard therapy at primary analysis.
73.9%: proportion of patients who achieved a CR with Breyanzi.
43.5%: proportion of patients who achieved a CR with standard therapy.
48.9%: proportion of patients who experienced any-grade CRS.
1%: proportion of patients who experienced Grade 3 CRS.
5 days: median time to onset of CRS.
4 days: median duration of CRS.
11 days: median time to onset of neurologic events.
4.5 days: median duration of neurologic toxicities.

Sources:

Bristol Myers Squibb, website: http://www.bms.com/