Posted: Thursday, August 18, 2022
On August 16, Roche announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for polatuzumab vedotin-piiq (Polivy) in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval of this combination therapy with a first-in-class anti-CD79b antibody-drug conjugate by April 2023.
The sBLA is based on results of the randomized phase III POLARIX trial of nearly 900 patients with newly diagnosed DLBCL, which is reportedly the first in 20 years to show a clinically meaningful improvement in progression-free survival compared with the current standard of care—rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The risk of disease progression, relapse, or death was reduced by 27% with polatuzumab vedotin plus R-CHP compared with R-CHOP, after a median follow-up of 28.2 months (hazard ratio = 0.73; 95% confidence interval = 0.57–0.95; P < .02).
Safety outcomes were consistent with those seen in previous clinical trials. The safety profile was comparable for polatuzumab vedotin plus R-CHP versus R-CHOP, including the rates of grade 3 or 4 adverse events (57.7% vs. 57.5%), serious adverse events (34.0% vs. 30.6%), grade 5 adverse events (3.0% vs. 2.3%), and adverse events leading to dose reduction (9.2% vs. 13.0%).