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FDA Approval Sought for Frontline Atezolizumab Plus Bevacizumab in HCC

Gina Columbus @ginacolumbusonc
Published: Monday, Jan 27, 2020

Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development of Genentech (Roche)

Levi Garraway, MD, PhD

A supplemental biologics license application (BLA) has been submitted to the FDA for the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.1

In earlier data from this study, independent reviewers determined that, at a median follow-up of 10.3 months, atezolizumab/bevacizumab elicited an ORR of 65% (n = 15) among the 23 evaluable patients.3 Additionally, the responses were observed across patient subgroups defined by etiology, geography, baseline alpha fetoprotein levels, and extrahepatic spread. The 65% ORR comprised a 4% (n = 1) complete response rate and a 61% (n = 14) partial response rate. Additionally, 7 (30%) patients had stable disease and 1 (4%) patient had progressive disease. A disease control rate of ≥6 months was reported for 16 (70%) patients.

References        

  1. Roche submits supplemental biologics license application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer [news release]. Roche. Published January 27, 2020. https://bit.ly/3aP84gz. Accessed January 27, 2020.         
  2. Genentech presents pivotal data demonstrating Tecentriq in combination with Avastin improves overall survival in people with the most common form of liver cancer [news release]. South San Francisco, CA: Genentech. Posted November 22, 2019. bit.ly/35rZfGc. Accessed November 22, 2019.
  3. Stein S, Pishvaian MJ, Lee MS, et al. Safety and clinical activity of 1L atezolizumab + bevacizumab in a phase Ib study in hepatocellular carcinoma (HCC).  J Clin Oncol. 2018;36(suppl 15; abstr 4074). doi: 10.1200/JCO.2018.36.15_suppl.4074.

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