Roche Announces Positive Phase III IMbrave150 Trial Results for Tecentriq plus Avastin in Unresectable Hepatocellular Carcinoma, Demonstrating Significant Improvement in Overall and Progression-Free Survival

Roche Group announced today (October 21) that a study aimed at evaluating the PD-L1 immune checkpoint inhibitor Tecentriq^®(Atezolizumab) in combination with Avastin^®The Phase III IMbrave150 clinical trial of (bevacizumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy achieved positive results in terms of overall survival (OS) and progression-free survival (PFS), demonstratingCompared with the current standard of care, sorafenib, patients in the atezolizumab plus bevacizumab combination immunotherapy group demonstrated statistically and clinically significant improvements in both overall survival and progression-free survival.。

The safety profile of the combination therapy with atezolizumab and bevacizumab is consistent with the known safety profiles of each drug when used alone, with no new safety signals identified. Roche will present detailed data from the IMbrave150 study at an upcoming international medical conference.

IMbrave150 is a global, multicenter, open-label Phase III study conducted in 501 patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy. Patients were randomized in a 2:1 ratio to receive combination therapy with atezolizumab and bevacizumab or sorafenib. Atezolizumab was administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle; bevacizumab was administered intravenously at a dose of 15 mg/kg on Day 1 of each 21-day cycle. Sorafenib was administered orally at a dose of 400 mg twice daily on Days 1–21 of each 21-day cycle. Patients received either the combination therapy or the control treatment until unacceptable toxicity occurred or the investigator determined there was no clinical benefit. The co-primary endpoints of the study were overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF) according to RECIST v1.1. Secondary efficacy endpoints included objective response rate (ORR), time to progression (TTP), and duration of response (DOR), as assessed according to RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (PROs), safety, and pharmacokinetics.

Hepatocellular carcinoma is an aggressive cancer with limited treatment options and is one of the leading causes of cancer-related deaths worldwide. Each year, 750,000 people are diagnosed with hepatocellular carcinoma, with the majority of cases occurring in Asia, nearly half of which are in China. In the United States, the number of liver cancer cases has tripled since 1980, and hepatocellular carcinoma is the fastest-rising cause of cancer-related mortality. Hepatocellular carcinoma primarily occurs in patients with cirrhosis caused by chronic hepatitis (hepatitis B or C) or alcohol abuse, and it is typically at an advanced stage at the time of diagnosis. The prognosis for unresectable hepatocellular carcinoma remains poor, with few systemic treatment options available, and the one-year survival rate after diagnosis is less than 50%.

It is worth noting that,This is the world’s first successful Phase III clinical study of immunotherapy for liver cancer.. The study data will also be submitted to regulatory authorities, including the U.S. Food and Drug Administration, the European Medicines Agency, and China's National Medical Products Administration, in support of new indication applications for atezolizumab.