The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for polatuzumab vedotin-piiq in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adults with previously untreated diffuse large B-cell lymphoma (DLBCL).
The sBLA is supported by data from the pivotal randomized, double-blind, placebo-controlled phase 3 POLARIX trial (ClinicalTrials.gov Identifier: NCT03274492) that evaluated the efficacy and safety of polatuzumab vedotin plus R-CHP in 879 adults with previously untreated DLBCL. Patients were randomly assigned 1:1 to receive either polatuzumab vedotin plus R-CHP for 6 cycles followed by rituximab for 2 cycles; or the current standard of care rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) for 6 cycles followed by rituximab for 2 cycles.
After a median follow-up of 28.2 months, treatment with polatuzumab vedotin plus R-CHP was associated with a 27% reduction in the risk of disease progression, relapse or death compared with R-CHOP (hazard ratio, 0.73; 95% CI, 0.57-0.95; P <.02). The safety profile of polatuzumab vedotin plus R-CHP was comparable to R-CHOP.
The FDA is expected to make a decision on approval by April 2, 2023.
“The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.”
Polatuzumab vedotin-piiq, a CD79b-directed antibody-drug conjugate, is currently marketed under the trade name Polivy and is indicated in combination with bendamustine and a rituximab product for the treatment of relapsed or refractory diffuse large B-cell lymphoma after at least 2 prior therapies.
FDA accepts supplemental Biologics License Application for Genentech’s Polivy combination for people with previously untreated diffuse large B-Cell lymphoma. News release. Genentech. Accessed August 16, 2022. https://www.businesswire.com/news/home/20220802005023/en/FDA-Accepts-Supplemental-Biologics-License-Application-for-Genentechs-Polivy-Combination-for-People-With-Previously-Untreated-Diffuse-Large-B-Cell-Lymphoma