Genentech has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab (BR) to treat diffuse large B-cell lymphoma (DLBCL) in adults.
The chemoimmunotherapy regimen is indicated for patients that have relapsed or refractory (R/R) DLBCL and were previously treated with at least two therapies.
Based on Seattle Genetics’ antibody-drug conjugate (ADC) technology, Polivy targets the CD79b protein that is specifically expressed on most of the B-cells.
The drug binds to CD79b and kills these B-cells by delivering an anti-cancer agent. Currently, it is being developed for the treatment of different types of non-Hodgkin’s lymphoma (NHL).
DLBCL is known to be the most common and aggressive form of NHL.
Genentech chief medical officer and global product development head Sandra Horning said: “Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens.
“Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”
The FDA’s approval comes after a review of findings from the randomised, controlled Phase Ib/II GO29365 clinical trial, where the chemoimmunotherapy regimen demonstrated higher response rates compared to BR in patients ineligible for a hematopoietic stem cell transplant.
According to study data, 40% of patients on Polivy and BR regimen experienced a complete response (CR), when compared to 18% treated with BR alone.
In addition, 45% of subjects in the Polivy combination arm achieved an objective response at the end of therapy versus 18% in the BR group.
Of the patients who had a complete or partial response with Polivy plus BR, 64% showed a duration of response (DOR) lasting at least six months, compared to 30% treated with BR alone.