Tecentriq–Avastin Combination Earns Breakthrough Therapy Designation for Liver Cancer

Genentech announced yesterday that the FDA has granted Breakthrough Therapy Designation to atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for patients with the most common form of liver cancer, advanced or metastatic hepatocellular carcinoma (HCC).

The designation was granted based on data from a phase 1b study that assessed the safety and clinical activity of the combination treatment. The results were presented at the American Society of Clinical Oncology’s Annual Meeting that took place in June 2018.

The open-label, multicenter study is evaluating the safety and clinical activity of a number of cancer immunotherapy combinations. Within this specific cohort, patients in Arm A received 1200 mg of atezolizumab plus 15 mg/kg of bevacizumab intravenously every 3 weeks until loss of clinical benefit or unacceptable toxicity was identified.

Researchers found that after a median follow up of 10.3 months, responses (defined as independent review facility per response evaluation criteria in solid tumors [RECIST v1.1]) were seen in 15 (65%) of 23 efficacy-evaluable participants. Assessment by investigators assessed per RECIST v1.1 demonstrated a response rate of 61% (14 out of 23 participants). However, median progression-free survival, duration of response, time to progression, and overall survival had not yet been reached after the median follow up. Importantly, no new safety concerns were identified beyond the established safety profiles for the individual medicines.

“Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide. 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,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a prepared statement.

This breakthrough therapy designation comes on the heels of a recent CDC report that found that death rates from liver cancer have increased 43% for American adults from 2000 to 2016.