Roche says Phase 3 IMbrave050 study of Tecentriq-Avastin met primary endpoint

Roche announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival, or RFS, at the prespecified interim analysis. The study is evaluating Tecentriq in combination with Avastin as adjuvant treatment following surgery for people with early-stage hepatocellular carcinoma, or HCC, at high risk of disease recurrence. The Tecentriq combination showed a statistically significant improvement in RFS in the intention-to-treat population of HCC patients who have an increased risk of recurrence following resection or ablation with curative intent, compared with active surveillance. Overall survival data were immature at the time of interim analysis and follow-up will continue to the next analysis. Safety for Tecentriq and Avastin was consistent with the known safety profile of each therapeutic agent and with the underlying disease. Results from the IMbrave050 study will be discussed with health authorities, including the US Food and Drug Administration and the European Medicines Agency, and presented at an upcoming medical meeting.