FDA approves polatuzumab vedotin combo for DLBCL


  • David Reilly
  • Oncology drug update
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Takeaway

  • On June 10, the FDA granted accelerated approval for polatuzumab vedotin-piiq, in combination with bendamustine and a rituximab product (BR), for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma not otherwise specified (R/R DLBCL NOS) after ≥2 prior therapies.

Why this matters

  • This is the first chemoimmunotherapy regimen approved in this setting.

Study design

  • Approval was based on study GO29365 (NCT02257567) of polatuzumab vedotin+BR (n=40) vs BR alone (n=40) in 80 patients with R/R DLBCL.
  • Patients were autologous hematopoietic stem cell transplantation-ineligible at study entry.
  • Funding: Genentech.

Key results

  • Completion of 6 treatment cycles: 49% with polatuzumab vedotin+BR vs 23% with BR.
  • Response at treatment end with polatuzumab vedotin+BR vs BR, respectively:
    • Objective response: 45% (95% CI, 29%-62%) vs 18% (95% CI, 7%-33%).
    • Complete response: 40% (95% CI, 25%-57%) vs 18% (95% CI, 7%-33%).
  • Duration of response with polatuzumab vedotin+BR at ≥6 and ≥12 months, respectively: 64% and 48%.
  • Most common grade ≥3 adverse events with polatuzumab vedotin+BR included neutropenia (42%), thrombocytopenia (40%), and anemia (24%).

Limitations

  • Accelerated approval; further trials required to verify clinical benefit.

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