On May 29, 2020, the FDA approved the combination of 2 immunotherapies, Tecentriq (atezolizumab; from Genentech), a PD-L1 inhibitor, and Avastin (bevacizumab; from Genentech), a VEGF inhibitor, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma, or liver cancer, who have not received systemic therapy.
Tecentriq and Avastin have each previously been approved alone or in combination with other therapies for multiple types of cancers. This is their first approval for liver cancer, and it is the first immunotherapy regimen to be approved by the FDA as first-line treatment for advanced liver cancer.
Before this approval, the standard therapy for first-line treatment of unresectable or metastatic liver cancer was Nexavar (sorafenib), a kinase inhibitor. It is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2020. Hepatocellular carcinoma is the most common type of liver cancer, accounting for about 75% of all liver cancer cases in the United States.
“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,” said Richard S. Finn, MD, Director, Signal Transduction and Therapeutics Program, UCLA Jonsson Comprehensive Cancer Center. “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,” Dr. Finn said.
The FDA approved this immunotherapy combination for advanced liver cancer based on results from the phase 3 IMbrave150 clinical trial. The study included 501 patients with unresectable or metastatic liver cancer who had not received systemic therapy and were divided into 2 groups.
The immunotherapy combination improved survival by 42% compared with Nexavar, and the average time without disease progression was 6.8 months with the immunotherapy combination versus 4.3 months with Nexavar. This resulted in a risk reduction of disease progression or death by 41% with immunotherapy. After 12 months of therapy, the survival with immunotherapy was 67.5% compared with 54.6% with Nexavar.
IMbrave150 is the first phase 3 clinical trial of immunotherapy to show an improvement in survival compared with Nexavar in patients with unresectable or metastatic liver cancer.
The most common serious side effects were gastrointestinal bleeding, infections, and fever.
