Tecentriq + Avastin combination in Phase III trial to treat Liver Cancer.- Genentech + Roche.

Genentech now reports that earlier this year, Genentech initiated IMbrave150 (NCT03434379), an open-label, multicenter, randomized Phase III study investigating the combination of Tecentriq and Avastin versus sorafenib in people with previously-untreated (first-line) locally advanced, unresectable or metastatic Hepatocellular Carcinoma (HCC) ( Liver Cancer). This study is currently enrolling.

About IMbrave150 (NCT03434379): IMbrave150 is a Phase III, multicenter, randomized, open-label study enrolling approximately 480 people with untreated advanced, unresectable or metastatic HCC 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq will be administered IV, 1200 mg on day 1 of each 21-day cycle and Avastin will be administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. Participants will receive the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints are OS and investigator-assessed ORR. Secondary endpoints include investigator-assessed PFS, TTP, DoR and IRF-assessed ORR, PFS, TTP and DoR.

HCC accounts for approximately 75 percent of all liver cancer cases diagnosed in the United States, with more than 20,000 men and more than 5,000 women diagnosed annually. HCC develops predominantly in people with cirrhosis due to chronic hepatitis B or C, and typically presents at an advanced stage where there are limited treatment options.