Conditional nod for polatuzumab combo to treat lymphoma

March 6, 2020 0 By FM

Polatuzumab vedotin has been granted conditional marketing authorisation by EC in combination with bendamustine plus rituximab (BR) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

The conditional approval 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. 

The 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. Complete response rates were assessed by an independent review committee.

Polatuzumab vedotin is a first-in-class anti-CD79b antibody-drug conjugate (ADC).