FDA Approves Combination Therapy for Common Form of Liver Cancer

Officials with the FDA have 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.

According to Genentech, the approval was based on results from the phase 3 IMbrave150 study, which demonstrated that atezolizumab in combination with bevacizumab reduced the risk of death (overall survival; OS) by 42% (hazard ratio [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.

IMbrave150 is the first phase 3 cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib, according to Genentech.

Serious adverse events (AEs) (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm. The most frequent serious AEs (≥2%) 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,” said Dr. Richard Finn, professor of Medicine at the David Geffen School of Medicine at UCLA and director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center, in a prepared statement. “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.”

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions.

The application also was included in the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

REFERENCE

FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer [news release]. South San Francisco, CA; May 29, 2020: Genentech. [email]. Accessed May 29, 2020.