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).
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.
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Preventative Chemotherapy? Not Quite, but Studies Are Underway in Immunoprevention
March 23rd 2024The Princess of Wales is likely referencing adjuvant chemotherapy, but there is a growing field of immunoprevention, which seeks to target precancerous lesions or block heritable cancers.
Read More
FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy
March 15th 2024The FDA has approved tislelizumab-jsgr (Tevimbra) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.
Read More