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FDA has approved Tecentriq in combination with Avastin for people with unresectable or metastatic hepatocellular carcinoma


The FDA ( U.S. Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) in combination with Avastin ( Bevacizumab ) for the treatment of people with unresectable or metastatic hepatocellular carcinoma ( HCC ) who have not received prior systemic therapy.

The approval was based on results from the phase III IMbrave150 study, which has demonstrated that Tecentriq in combination with Avastin reduces the risk of death ( overall survival; OS ) by 42% ( hazard ratio [ HR ]=0.58; 95% CI: 0.42-0.79; p=0.0006 ) and reduces the risk of disease worsening or death ( progression-free survival; PFS ) by 41% ( HR=0.59; 95% CI: 0.47-0.76; p less than 0.0001 ), compared with Sorafenib ( Nexavar ).
IMbrave150 is the first phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic hepatocellular carcinoma compared with Sorafenib.
Serious adverse reactions ( grade 3-4 ) occurred in 38% of people in the Tecentriq and Avastin arm. The most frequent serious adverse reactions ( 2% or more ) were bleeding in the gastrointestinal tract, infections and fever.

The results were published in the New England Journal of Medicine.

IMbrave150 is a multicenter, open-label study of 501 people with unresectable or metastatic hepatocellular carcinoma who had not received prior systemic therapy.
People were randomized 2:1 to receive the combination of Tecentriq and Avastin or Sorafenib. Tecentriq was administered intravenously ( IV ), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle.
People have received the combination or the control arm treatment until disease progression or unacceptable toxicity.
The two primary endpoints were overall survival and independent review facility ( IRF )-assessed progression-free survival per RECIST v1.1. Additional study endpoints were IRF-assessed overall response rate ( ORR ) per RECIST and mRECIST.

Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1, expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab may enable the re-activation of T cells.
Atezolizumab may also affect normal cells.

Bevacizumab is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis.
Bevacizumab is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells.
The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body.

According to the American Cancer Society, it is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2020. Liver cancer incidence has more than tripled since 1980.
hepatocellular carcinoma accounts for approximately 75% of all liver cancer cases in the United States.
Hepatocellular carcinoma develops predominantly in people with cirrhosis due to chronic hepatitis ( B and C ) or alcohol consumption, and typically presents at an advanced stage where there are limited treatment options. ( Xagena )

Source: Genentech, 2020

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