Officials with the FDA approved atezolizumab (Tecentriq, Genentech) in combination with bevacizumab (Avastin) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Officials with the FDA approved atezolizumab (Tecentriq, Genentech) in combination with bevacizumab (Avastin) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Based on results from the phase 3 IMbrave150 study, the application was approved under the FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program.
The multi-center, open-label study, which was published in the New England Journal of Medicine, included 501 patients with unresectable or metastatic HCC who had received prior systemic therapy. Patients were randomized to receive either the combination of atezolizumab and bevacizumab or sorafenib. Atezolizumab was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and bevacizumab was administered by mouth, 400 mg twice per day, on days 1 through 21 of each 21-day cycle.
The results showed that atezolizumab plus bevacizumab reduced the risk of death (overall survival [OS]) by 42% (HR=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival [PFS]) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib. Serious adverse effects (AEs) occurred in 38% of patients in the atezolizumab and bevacizumab arm. The most frequent AEs reported were bleeding in the gastrointestinal tract, infections, and fever.
“The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” Richard Finn, MD, professor of medicine at the David Geffen School of Medicine UCLA Jonsson Comprehensive Cancer Center. “For the first time we have a regimen that markedly improves survival after sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile.”
IMbrave150 is the first study to show an improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable or metastatic HCC compared with sorafenib, according to Genentech.
1. FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer. News Release. Genentech; May 29, 2020. Accessed June 1, 2020. https://www.gene.com/media/press-releases/14856/2020-05-29/fda-approves-genentechs-tecentriq-in-com.