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FDA Grants Breakthrough Therapy Designation for Atezolizumab/Bevacizumab Combination as First-Line Treatment for Advanced or Metastatic HCC

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The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer. The designation is based on data from a phase Ib study assessing the safety and clinical activity of the combination.

Findings from the study were presented by Stein et al at the 2018 ASCO Annual Meeting (Abstract 4074). These data showed that after a median follow-up of 10.3 months, responses (independent review facility per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST v1.1]) were seen in 15 (65%) of 23 efficacy-evaluable patients.

Responses were seen in all subgroups, including on the basis of the cause of their disease (etiology: hepatitis B, hepatitis C, and nonviral), region (Asia, exclusively Japan, or Japan/United States), baseline alpha-fetoprotein levels (high/low), or spread of the tumor beyond the liver (yes/no). Assessment by investigators per RECIST v1.1 demonstrated a response rate of 61% (14 out of 23 patients).

Median progression free survival, duration of response, time to progression, and overall survival have not yet been reached after a median follow-up of 10.3 months. Results will be presented at a future medical congress when updated data from an expanded cohort are available.

In the safety-evaluable population (n = 43), 28% of patients (n = 12) experienced grade 3 or 4 treatment-related adverse events, and no treatment-related grade 5 adverse events were observed. No new safety signals were identified beyond the established safety profiles for the individual medicines.

Earlier this year, Roche initiated IMbrave150, an open-label, multicenter, randomized phase III study investigating the combination of atezolizumab and bevacizumab vs sorafenib (Nexavar) as first-line therapy for locally advanced, unresectable, or metastatic HCC. This study is currently enrolling.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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