CHMP recommends approval of Polivy + bendamustine + MabThera for diffuse large B-cell lymphoma.- Roche

Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation of Polivy is expected from the European Commission in the near future.

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 Polivy 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. Complete response rates were assessed by an independent review committee. The study also showed that Polivy plus BR more than doubled OS, with a median OS of 12.4 months in the Polivy arm, versus 4.7 months in the BR alone arm (HR=0.42). The most commonly reported adverse events in people treated with Polivy in combination with BR include anaemia, thrombocytopenia, neutropenia, fatigue, diarrhoea, nausea, and pyrexia.

Comment Polivy was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017, the first PRIME designation for a Roche medicine. We will continue to work with the EMA and local health providers to make Polivy available to patients as quickly as possible. In addition, Polivy plus BR was granted accelerated approval by the US Food and Drug Administration for people with R/R DLBCL who have received at least two prior therapies, in June 2019.