Roche's 'T+A' Therapy Approved as First-Line Treatment for Unresectable Hepatocellular Carcinoma

On June 4, 2021, Roche announced that the China National Medical Products Administration (NMPA) approved the anti-angiogenic targeted drug Avastin® (English trade name: Avastin®, generic name: bevacizumab) in combination with atezolizumab (hereinafter referred to as the "T+A" combination therapy) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. This approval was primarily based on the results of the Phase III IMbrave150 clinical trial.

Primary liver cancer is the fourth most common malignancy and the second leading cause of cancer-related mortality in China. Although China accounts for only 18.4% of the global population, it represents 55.4% of new liver cancer cases and 53.9% of liver cancer deaths worldwide annually. This translates to over 1,000 patients diagnosed with liver cancer daily, with hepatocellular carcinoma (HCC) accounting for 85%–90% of cases. Currently, the 5-year survival rate for patients in China is only approximately 12%, and liver cancer continues to pose a severe threat to people's lives and health.

Results from the global, phase III, multicenter, open-label IMbrave150 clinical trial demonstrated that, compared with the previous standard of care, the "T+A" combination therapy significantly reduced the risk of death and disease progression, and the time to deterioration in patient-reported quality of life and functioning was superior to that of standard treatment. These results were published in 《The New England Journal of Medicine》 on May 14, 2020.

Based on these study results, China's National Medical Products Administration (NMPA) officially approved in October 2020 Roche's atezolizumab (brand name: Tecentriq®) in combination with bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy. In January 2021, Roche officially reported the latest overall survival (OS) results from the IMbrave150 study at the ASCO Gastrointestinal Cancers Symposium (ASCO GI). The data showed that patients treated with the "T+A" combination therapy achieved a median overall survival (mOS) of 19.2 months, with the Chinese subgroup reaching an mOS of 24.0 months.

“T+A” combination therapy is the first first-line regimen for advanced hepatocellular carcinoma to yield positive results in over a decade, with its superior therapeutic efficacy attributed to its novel mechanism of action.

Atezolizumab is a monoclonal antibody designed to bind directly to the PD-L1 ligand protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By blocking the PD-L1 pathway, atezolizumab can effectively activate T cells.

Bevacizumab is a monoclonal antibody that specifically binds to VEGF protein, preventing its interaction with receptors on vascular cells to disrupt the tumor blood supply. It not only inhibits tumor growth but also enhances the antitumor efficacy of anti-PD-L1 antibodies by modulating the tumor immune microenvironment. The powerful combination of "T+A" thereby achieves a "1+1>2" therapeutic effect.

As the world's first and currently only approved first-line immunotherapy combination regimen for advanced hepatocellular carcinoma, the “T+A” combination therapy has been listed as a preferred first-line treatment option for advanced hepatocellular carcinoma by multiple domestic and international clinical guidelines.

Prior to this approval, Avastin® had already been approved in China for use in combination with chemotherapy for the treatment of metastatic colorectal cancer (mCRC), as first-line treatment for patients with unresectable advanced, metastatic, or recurrent non-squamous non-small cell lung cancer (NSCLC), and for the treatment of recurrent glioblastoma (rGBM) in adults.

Managing Editor: Liuli

Disclaimer: This article is reprinted from Yaozhi Network. Copyright belongs to the original rights holder. It is intended for information dissemination and does not represent the views of this platform. Should there be any issues concerning the content, copyright, or other matters, please contact us by leaving a message on this website, and we will promptly remove the content!