Roche's Tecentriq Plus Bevacizumab Nears Approval in China for First-Line Treatment of Unresectable Hepatocellular Carcinoma

On October 26, Roche’s supplemental Biologics License Application (sBLA) for the second indication of atezolizumab (Tecentriq) in China entered the “under review” status, with formal approval expected in the near future. The indication is for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not previously received systemic therapy, in combination with bevacizumab.

Hepatocellular carcinoma (HCC) is a highly aggressive cancer with limited treatment options and is one of the leading causes of cancer-related deaths worldwide, accounting for approximately 90% of liver cancer cases. Globally, there are 750,000 new cases of HCC annually, with the majority occurring in Asia and nearly half in China. According to data from the 2015 Annual Report on Cancer Statistics in China, there are approximately 370,000 new cases of HCC each year in China, resulting in 326,000 deaths. If approved for this indication, Roche’s Tecentriq in combination with bevacizumab would become the first immunotherapy-based combination regimen for the first-line treatment of HCC.

Roche submitted a marketing authorization application to the NMPA based on data from the Chinese cohort of the IMbrave 150 study, which evaluated the efficacy and safety of Tecentriq plus bevacizumab versus sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC). The study employed a global, multicenter, open-label design, in which 501 patients with unresectable HCC who had not previously received systemic therapy were randomized in a 2:1 ratio. Among the 194 Chinese patients enrolled in the study (137 from the global IMbrave 150 trial and 57 from the China expansion study), 133 patients were randomized to receive Tecentriq plus bevacizumab, and 61 patients received sorafenib.

The results showed that Tecentriq plus Avastin as a first-line therapy significantly prolonged overall survival (OS) in Chinese patients compared with sorafenib (immature vs. 11.4 months), reducing the risk of death by 56% (HR = 0.44). It also significantly prolonged progression-free survival (PFS) (5.7 vs. 3.2 months), reducing the risk of disease progression by 40% (HR = 0.60). These data are consistent with the global findings from the IMbrave150 study. In terms of safety, Tecentriq plus bevacizumab was generally well tolerated with manageable toxicity, consistent with known data.

Roche’s Tecentriq was first approved in China in February 2020 for the treatment of small cell lung cancer (SCLC). If approved, this first-line indication for liver cancer would become the second approved indication for Tecentriq in China. Additionally, Roche’s third marketing application for Tecentriq in China has been included in the priority review program. This application is for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), and whose tumors have been assessed as having ≥50% PD-L1 staining positivity in tumor cells (TC≥50%) or PD-L1-positive immune cells (IC) covering ≥10% of the tumor area (IC≥10%).