CHMP recommends polatuzumab combo for DLBCLJanuary 6, 2020
Roche said the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for polatuzumab vedotin (Polivy) in combination with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The positive CHMP opinion is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a haematopoietic stem cell transplant.
Results of the study showed that 40% of people treated with polatuzumab plus BR achieved a complete response (n=16/40), meaning no cancer could be detected at the time of assessment, compared to 17.5% (n=7/40) with BR alone.
The study also showed that polatuzumab plus BR more than doubled OS, with a median OS of 12.4 months in the polatuzumab arm, versus 4.7 months in the BR alone arm (HR=0.42).
Polatuzumab, an anti-CD79b antibody-drug conjugate (ADC) was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017