FDA Grants Breakthrough Therapy Designation to Tecentriq, Avastin Combo for Liver Cancer
Genentech announced 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.
This article originally appeared on The American Journal of Managed Care.
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.
Click to continue reading on The American Journal of Managed Care.