Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMbrave150 study, evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy, met both of its co-primary endpoints demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared with standard-of-care sorafenib.
Safety for the combination of Tecentriq and Avastin was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. Data from the IMbrave150 study will be presented at an upcoming medical meeting.
“We are very pleased with the results of our study testing the combination of Tecentriq and Avastin, which marks the first treatment in more than a decade to improve overall survival in people with unresectable hepatocellular carcinoma who have not received prior systemic therapy,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “HCC is a major cause of death globally and particularly in Asia, making this study an important step in our mission of addressing unmet medical needs for patients around the world. We will submit these data to global health authorities as soon as possible. Our hope is to bring a new treatment to people with this aggressive disease who currently have limited options.”
In July 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMbrave150 study
IMbrave150 is a global Phase III, multicenter, open-label study of 501 people with unresectable HCC who have not received prior systemic therapy. People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously, 1200 mg on day 1 of each 21-day cycle, and Avastin was administered intravenously, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints were OS and PFS by independent review facility (IRF) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Secondary efficacy endpoints included overall response rate (ORR), time to progression (TTP) and duration of response (DoR), as measured by RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (PROs), safety and pharmacokinetics.