BioCentury
ARTICLE | Clinical News

Gazyva vs. rituximab PFS numbers unveiled

November 8, 2013 1:53 AM UTC

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit provided detailed data on Thursday from the Phase III CLL11 (BO21004) trial evaluating the company's Gazyva obinutuzumab ( GA101) to treat previously untreated chronic lymphocytic leukemia (CLL). In Stage 2 of the trial, Gazyva plus chlorambucil chemotherapy led to a median progression-free survival (PFS), the primary endpoint, of 26.7 months vs. 15.2 months for Rituxan rituximab plus chlorambucil (p<0.0001). In July, Genentech said Gazyva plus chlorambucil met the primary PFS endpoint vs. Rituxan plus chlorambucil, but the company did not provide details. Median overall survival (OS), a secondary endpoint, has not yet been reached in either treatment arm. The trial is being conducted in cooperation with the German CLL Study Group. Data are slated to be presented at the American Society of Hematology meeting in December (see BioCentury Extra, July 24).

Last Friday, FDA approved Gazyva in combination with chlorambucil to treat previously untreated CLL. Gazyva is the first product with breakthrough therapy designation to be approved by the agency. Genentech launched Gazyva in the U.S. on Monday with a wholesale acquisition cost of $41,300 for a six-month course of treatment. The company said the cost of a course of treatment with Rituxan for CLL is about $34,400. According to Genentech, a patient with CLL typically takes Rituxan in combination with chemotherapy for about six months. ...