Genentech, a member of the Roche Group, announced new data from the Phase III IMbrave050 study that show Tecentriq plus Avastin demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent.
“Four out of five people with HCC who receive surgery with curative intent may still see their cancer return. Thus, an urgent need exists for adjuvant treatments to prevent early recurrence and improve survival rates,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “With Tecentriq plus Avastin already a standard of care in unresectable HCC, we are pleased with the potential of these results and look forward to seeing more mature data.”
The Tecentriq investigational combination reduced the risk of cancer returning by 28%, compared with active surveillance, at a median follow-up of 17.4 months (independent review facility [IRF]-RFS hazard ratio [HR]=0.72, 95% CI: 0.56-0.93; P=0.0120). The IRF-RFS findings were generally consistent across clinical subgroups. Overall survival (OS), a key secondary endpoint, was immature at the time of data analysis. The safety data for Tecentriq plus Avastin were consistent with the well-established safety profile of each therapeutic treatment and with the underlying disease.
The late-breaking data will be presented at the AACR Annual Meeting 2023 and have been included as part of the official press program. Discussions with health authorities are ongoing and follow-up will continue for the final RFS data and more mature OS data at the next planned analysis.
The IMbrave050 study is part of Genentech’s overall commitment to drive fundamental treatment change and improve outcomes for people living with liver cancer. Tecentriq plus Avastin was the first treatment in over a decade to significantly improve OS over the existing standard of care, based on data from the IMbrave150 study. The Tecentriq combination quickly became a standard of care in unresectable HCC and is clearly defined as a preferred front-line treatment in multiple international clinical guidelines.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types.
SOURCE: Businesswire