FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified after at least two prior therapies.
Study GO29365
Approval was based on Study GO29365, an open-label, multicenter clinical trial that included a cohort of 80 patients with relapsed or refractory DLBCL after at least one prior regimen. Patients were randomly assigned 1:1 to receive either polatuzumab vedotin-piiq in combination with bendamustine and a rituximab product or bendamustine and a rituximab product for six 21-day cycles. Polatuzumab vedotin-piiq, 1.8 mg/kg by intravenous infusion, was given on day 2 of cycle 1 and on day 1 of subsequent cycles. Bendamustine (90 mg/m2 intravenously) was administered on days 2 and 3 of cycle 1 and on days 1 and 2 of subsequent cycles. A rituximab product (375 mg/m2 intravenously) was administered on day 1 of each cycle. Efficacy was based on complete response (CR) rate and response duration as determined by an independent review committee.
Results
At the end of therapy, the CR rate was 40% (95% confidence interval [CI] = 25%–57%) with polatuzumab vedotin-piiq in combination with bendamustine and a rituximab product compared with 18% (95% CI = 7%–33%) with bendamustine and a rituximab product alone. The overall response rate was 63% with polatuzumab vedotin-piiq in combination with bendamustine and a rituximab product compared with 25% with bendamustine and a rituximab product. Of the 25 patients who achieved partial or complete response to polatuzumab vedotin-piiq in combination with bendamustine and a rituximab product, 16 (64%) had response durations of at least 6 months and 12 (48%) had response durations of at least 12 months.
The most common adverse reactions with polatuzumab vedotin-piiq in combination with bendamustine and a rituximab product (incidence of at least 20%) included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia. Serious adverse reactions occurred in 64% of patients, most often from infection. Cytopenias were the most common reason for treatment discontinuation (18% of all patients).
The prescribing information for polatuzumab vedotin-piiq includes warnings and precautions for peripheral neuropathy, infusion-related reactions, myelosuppression, serious and opportunistic infections, progressive multifocal leukoencephalopathy, tumor lysis syndrome, hepatotoxicity, and embryo-fetal toxicity.
The recommended dose of polatuzumab vedotin-piiq is 1.8 mg/kg as an intravenous infusion over 90 minutes every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated; premedicate with an antihistamine and antipyretic, and administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.
View the full prescribing information for polatuzumab vedotin-piiq.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
