FDA approves immunotherapy regimen for advanced liver cancer
The FDA approved atezolizumab in combination with bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The combination of atezolizumab (Tecentriq, Genentech) — a monoclonal antibody designed to bind with PD-L1 — and bevacizumab (Avastin, Genentech) is the only cancer immunotherapy regimen approved for this patient population.
“We’re excited that [this] approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Roche, said in a company-issued press release.
The FDA based the approval on results of the randomized phase 3 IMbrave 150 study, which included 501 patients with unresectable or metastatic HCC who had not received prior systemic therapy.
Researchers randomly assigned two-thirds of patients to atezolizumab dosed at 1,200 mg via IV plus bevacizumab dosed at 15 mg/kg via IV on day 1 of each 21-day cycle. One-third of patients received oral sorafenib (Nexavar, Bayer) dosed at 400 mg twice daily on days 1 through 21 of each 21-day cycle. Treatment continued until disease progression or unacceptable toxicity.
OS and independent review facility-assessed PFS served as primary endpoints. Secondary endpoints included overall response rate as assessed by independent review.
As Healio previously reported, patients assigned the atezolizumab-bevacizumab combination achieved significantly longer OS (HR = 0.58; 95% CI, 0.42-0.79) and PFS (HR = 0.59; 95% CI, 0.47-0.76).
Thirty-eight percent of patients assigned the combination experienced grade 3 or grade 4 serious adverse reactions, the most frequent of which 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 S. Finn, MD, professor of medicine at David Geffen School of Medicine at UCLA and director of the signal transduction and therapeutics program at UCLA Jonsson Comprehensive Cancer Center, said in the release. “For the first time, we have a regimen that markedly improves survival over 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.”