The trial met its co-primary endpoints, showing statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to standard-of-care, Bayer’s Nexavar.
Genentech, a Roche company, announced that its Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) hit the mark on its Phase III IMbrave150 trial in unresectable hepatocellular carcinoma (HCC) patients who have not receive previous systemic therapy. In July 2018, the U.S. Food and Drug Administration (FDA) granted the combination in this patient population Breakthrough Therapy Designation based on results from an ongoing Phase Ib trial.
Hepatocellular carcinoma, a form of liver cancer, has been diagnosed in more than 42,000 people in the U.S. this year, and has tripled since 1980, with HCC responsible for 75% of all liver cancer cases in the U.S. HCC predominantly is the result of cirrhosis due to chronic hepatitis B and C or alcohol consumption. It tends to present at the advanced stage when treatment options are limited.
The trial met its co-primary endpoints, showing statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to standard-of-care, Bayer’s Nexavar (sorafenib). Safety signals were consistent with those known for both Tecentriq and Avastin.
“We are very pleased with the results of our study testing the combination of Tecentriq and Avastin, which marks the first treatment in more than a decade to improve overall survival in people with unresectable hepatocellular carcinoma who have not received prior systemic therapy,” said Levi Garraway, chief medical officer and head of Global Product Development for Genentech.
Garraway went on to say, “HCC is a major cause of death globally and particularly in Asia, making this study an important step in our mission of addressing unmet medical needs for patients around the world. We will submit these data to global health authorities as soon as possible. Our hope is to bring a new treatment to people with this aggressive disease who currently have limited options.”
The company expects to submit to regulators in the U.S., Europe and China. The China market in particular is of interest to the company. Liver cancer is higher in China and may make up 50% of new cases globally each year. Roche’s sales in China have sped up this year, increasing more than 50% in the first three quarters of 2019.
Tecentriq’s revenue is growing, but it’s a late-comer to the checkpoint inhibitor market, falling significantly behind Merck’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab). Those two checkpoint inhibitors tend to be the first choice to treat more common cancers, such as non-small cell lung cancer. But Tecentriq is making forays into small targets like triple-negative breast cancer.
“This is an opportunity for Roche to continue its expansion in Asia, and especially in China,” Michael Nawrath, an analyst with Zuercher Kantonalbank, wrote in a note to investors.
IMbrave150 randomized 501 patients with unresectable HCC who hadn’t received previous systemic therapy. They were split 2:1 to receive the Tecentriq and Avastin combination or sorafenib. Both Tecentriq and Avastin were administered intravenously, whereas sorafenib is an oral medication. The patients in both arms received treatment until unacceptable toxicity or there was no longer any clinical benefit.
