Positive results were announced from a phase 3 study evaluating atezolizumab (Tecentriq®), a programmed death-ligand 1 blocking antibody, in combination with bevacizumab (Avastin®), vascular endothelial growth factor inhibitor, as adjuvant treatment following surgery in adults with early-stage hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
The multicenter, open-label, randomized IMbrave050 study (ClinicalTrials.gov Identifier: NCT04102098) included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent. Patients were randomly assigned 1:1 to receive either atezolizumab 1200mg every 3 weeks plus bevacizumab 15mg/kg every 3 weeks for a maximum of 12 months, or no intervention with active surveillance.
In a prespecified interim analysis, results showed that treatment with atezolizumab plus bevacizumab met the primary endpoint demonstrating a statistically significant improvement in recurrence-free survival in the intention-to-treat population compared with active surveillance. The overall survival data was immature at the time of interim analysis and follow-up will continue. The safety profiles for atezolizumab and bevacizumab were consistent with their known profiles.
“Today, more than 70% of people with early-stage HCC may have their cancer return after surgery, which is associated with poorer prognosis and shorter survival. IMbrave050 is the first phase 3 study to show that a cancer immunotherapy combination reduced the risk of disease returning in people with this type of HCC,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We are excited by the clinical benefit that this adjuvant Tecentriq combination may bring to people with early liver cancer and look forward to seeing more mature data to further confirm the benefit.”
Tecentriq in combination with Avastin is approved for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.
Genentech’s Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a phase III trial. News release. Genentech. Accessed January 19, 2023. https://www.businesswire.com/news/home/20230118005680/en/Genentech%E2%80%99s-Tecentriq-Plus-Avastin-Is-the-First-Treatment-Combination-to-Reduce-the-Risk-of-Cancer-Returning-in-People-With-Certain-Types-of-Early-Stage-Liver-Cancer-in-a-Phase-III-Trial.