The Food and Drug Administration approved the combination of Tecentriq and Avastin in patients with unresectable or metastatic hepatocellular carcinoma, making it the first immunotherapy regimen to be approved for this cancer type.
The Food and Drug Administration (FDA) on Friday approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received previous systemic therapy.
The agency based its approval on results from the phase 3 IMbrave150 trial, which demonstrated that the combination improved overall survival by 42% and improved progression-free survival by 41% compared with the current standard of care, Nexavar (sorafenib).
“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, director of the signal transduction and therapeutics program at the UCLA Jonsson Comprehensive Cancer Center, in a press 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.”
The initial review of the application was made under the FDA’s Project Orbis initiative, which allows for the concurrent submission and review of cancer medications among international partners.
In the international, multicenter, open-label trial, 501 patients with unresectable HCC who did not receive prior systemic therapy were randomized 2:1 to receive the Tecentriq and Avastin combination or Nexavar alone.
Tecentriq was administered intravenously (IV) at 1200 mg on the first day of each 21-day cycle; IV Avastin was administered at 15 mg/kg on the first day of each 21-day cycle. Oral Nexavar was administered at 400 mg twice daily on days 1 to 21 of each 21-day cycle. In both arms, treatment was given until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Serious side effects (Grade 3-4) occurred in 38% of patients in the Tecentriq and Avastin arm. The most common side effects included bleeding in the gastrointestinal tract, infections and fever.
“We're excited that today’s 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,” said Dr. Levi Garraway, chief medical officer and head of Global Product Development at Genentech. “The application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.”