On June 10, 2019, the FDA accelerated the approval of polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody-drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar; BR) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after ≥2 previous therapies.
The FDA approval of polatuzumab was based on results from the phase 1b/2 GO29365 clinical trial that included
80 patients with relapsed or refractory DLBCL who had received ≥1 previous treatment regimens. Patients were randomized in a 1:1 ratio to polatuzumab plus BR or BR alone for six 21-day cycles. Efficacy was based on complete response rate and duration of response, defined as the time the disease remained in remission. Results showed a complete response rate of 40% in patients treated with polatuzumab plus BR versus 18% in those treated with BR alone. Of the 25 patients who achieved a partial or complete response with polatuzumab plus BR, 16 (64%) had a duration of response of ≥6 months and 12 (48%) had a duration of response of ≥12 months.
The most common (≥20%) adverse effects associated with polatuzumab plus BR were neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.