Pivotal Phase III IMbrave050 study, which investigated Tecentriq plus Avastin in people with early-stage hepatocellular carcinoma or HCC at high risk of recurrence following surgery, met primary endpoint of recurrence-free survival at the prespecified interim analysis, Genentech, a member of the Roche Group (RHHBY), said in a statement on Thursday.
The Tecentriq combination showed a statistically significant improvement in recurrence-free survival 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.
According to the company, 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.
The company noted that results from the IMbrave050 study will be discussed with health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency, and presented at an upcoming medical meeting.
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