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FDA grants Tecentriq-Avastin combination breakthrough therapy designation for liver cancer
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The FDA granted breakthrough therapy designation to atezolizumab in combination with bevacizumab as a first-line treatment for patients with advanced metastatic hepatocellular carcinoma.
The FDA based this designation on results from a phase 1b study that evaluated atezolizumab (Tecentriq, Genentech), an anti-PD-L1 therapy, and bevacizumab (Avastin, Genentech), an anti-VEGF therapy, among patients with hepatocellular carcinoma.
Researchers presented data at ASCO Annual Meeting.
Results showed that among 23 efficacy-evaluable patients, 65% demonstrated responses after a median follow-up of 10.3 months. Researchers observed responses in all subgroups, including those based on the etiology of the patient’s disease, region, baseline alpha-fetoprotein levels or spread of tumor beyond the liver.
Median PFS, duration of response, time to progression and OS had not yet been reached.
Among 43 safety-evaluable patients, 28% experienced a grade 3 or grade 4 treatment related-adverse events. Researchers did not observe any grade 5 adverse events nor any new safety signals beyond the established safety profiles of the individual medicines.
“Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a press release. “Preliminary data from the combination of Tecentriq and Avastin in this disease are promising and we look forward to working with health authorities to make this potential treatment regimen available to people with hepatocellular carcinoma as soon as possible.”
Enrollment is ongoing for a phase 3 study of atezolizumab plus bevacizumab compared with sorafenib (Nexavar, Bayer) among patients with previously untreated unresectable or metastatic hepatocellular carcinoma.