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European Union

European Commission Approves Breyanzi for Treatment of Relapsed or Refractory Lymphoma

Strategic Insights

— 1 min read

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/
  • Copyright Bristol-Myers Squibb 2023.

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