The US Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) to treat adults who have previously untreated diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater.
The FDA also converted another approval of polatuzumab vedotin from accelerated approval to regular approval. Polatuzumab vedotin now has regular approval for use in combination with bendamustine and rituximab to treat patients with relapsed or refractory DLBCL who have received at least 2 prior therapies.
The approval of polatuzumab vedotin plus R-CHP as first-line treatment was based on data from the phase 3 POLARIX trial (ClinicalTrials.gov Identifier: NCT03274492), which included adults with previously untreated DLBCL. Patients were randomly assigned to receive either polatuzumab vedotin plus R-CHP for 6 cycles followed by rituximab for 2 cycles (n=440) or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles followed by rituximab for 2 cycles (n=439).
At a median follow-up of 24.7 months, progression-free survival (PFS) was superior in the polatuzumab vedotin arm (hazard ratio [HR], 0.73; 95% CI, 0.57-0.95; P =.0177). PFS was superior in the polatuzumab vedotin arm among patients with DLBCL NOS (HR, 0.75; 95% CI, 0.57-0.99) and among those with HGBL (HR, 0.48; 95% CI, 0.21-1.08).
A significant improvement in modified event-free survival was observed in the polatuzumab vedotin arm as well (HR, 0.75; 95% CI, 0.58-0.96; P =.0244). In the final analysis of overall survival, there was no significant difference between the arms (HR, 0.94; 95% CI, 0.67-1.33).
The safety profile of polatuzumab vedotin plus R-CHP was comparable to that of R-CHOP. The most common adverse events were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. The most common grade 3-4 adverse events were lymphopenia, neutropenia, hyperuricemia, and anemia.
1. FDA approves Genentech’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma. News release. Genentech. April 19, 2023. Accessed April 20, 2023.
2. Package insert. Genentech; 2023. Accessed April 20, 2023. https://www.gene.com/download/pdf/polivy_prescribing.pdf
This article originally appeared on MPR