- 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.
- 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.
- 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%).
- Accelerated approval; further trials required to verify clinical benefit.
Click here for full Prescribing Information