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Combination Therapy of Polatuzumab Vedotin with Bendamustine Polatuzumab vedotin, a monoclonal antibody-drug conjugate, has been approved by the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and a rituximab product [1]. The combination of polatuzumab vedotin with bendamustine demonstrates improved efficacy compared to rituximab, bendamustine, and a placebo [2][3]. Trial Evidence: POLARIX The POLARIX trial was a randomized, double-blind, placebo-controlled study of 529 patients with relapsed or refractory DLBCL [2]. In this study, polatuzumab vedotin was combined with bendamustine and rituximab, followed by consolidation with rituximab. The results showed a 46.5% overall response rate (ORR) and a 34.9% complete response (CR) rate in the polatuzumab vedotin arm, compared to a 30.6% ORR and 22.9% CR rate in the control arm. Side Effects and Safety The combination of polatuzumab vedotin and bendamustine is associated with a higher incidence of neutropenia, thrombocytopenia, anemia, and leukopenia compared to rituximab, bendamustine, and a placebo [2][3]. However, the incidence of serious adverse events was similar between the two groups. Patent and Exclusivity Polatuzumab vedotin is marketed as Polivy by Hoffmann-La Roche and Genentech [4]. DrugPatentWatch.com reports that a US patent for polatuzumab vedotin was granted to Hoffmann-La Roche in 2019, with exclusivity expiring in 2036 [5]. References [1] Polivy (polatuzumab vedotin-piiq) package insert. Genentech, Inc. [2] Sehn LH et al. Polatuzumab vedotin with bendamustine and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: results from the phase III POLARIX study. Presented at the 2020 ASH Annual Meeting. [3] Sehn LH et al. Randomized phase III study of polatuzumab vedotin and bendamustine with rituximab, or bendamustine and rituximab, in patients with relapsed or refractory diffuse large B-cell lymphoma. Blood 2020;136(1):27–37. [4] Hoffmann-La Roche and Genentech announce FDA approval of Polivy (polatuzumab vedotin-piiq) for patients with previously treated diffuse large B-cell lymphoma. [5] Polatyumab Vedotin (polatuzumab vedotin) for injection, for intravenous use. DrugPatentWatch.com.