Roche's Atezolizumab-Based Immunotherapy Combination Approved in China for First-Line Treatment of Hepatocellular Carcinoma

On October 28, 2020, Roche announced that the China National Medical Products Administration (NMPA) had approved its innovative cancer immunotherapy drug atezolizumab (brand name: Tecentriq®) in combination with bevacizumab (hereinafter referred to as the “T+A” combination therapy) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not previously received systemic therapy. The approval was primarily based on the results of the Phase III clinical trial IMbrave150, which included an analysis of a Chinese subgroup of 194 patients.

Primary liver cancer is the fourth most common malignant tumor and the second leading cause of cancer-related deaths in China. Although China accounts for only 18.4% of the global population, it contributes 55.4% of new liver cancer cases and 53.9% of liver cancer deaths worldwide each year. This equates to more than 1,000 patients being diagnosed with liver cancer daily, with hepatocellular carcinoma (HCC) accounting for 85%–90% of these cases. Currently, the 5-year survival rate for liver cancer patients in China is only 12.2%, posing a severe threat to the lives and health of the population.

In recent years, driven by the continuous deepening of drug review and approval system reforms, an increasing number of innovative drugs urgently needed in clinical practice have been introduced to China at a faster pace, benefiting more Chinese patients. In February this year, China’s National Medical Products Administration (NMPA) granted priority review status to the “T+A” combination therapy for first-line treatment of advanced unresectable hepatocellular carcinoma. In May this year, the U.S. Food and Drug Administration (FDA) approved the “T+A” combination therapy for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who had not previously received systemic therapy. To date, multiple domestic and international clinical guidelines have listed “T+A” as a preferred first-line treatment option for advanced hepatocellular carcinoma.

Professor Qin Shukui, Principal Investigator for China in the IMbrave150 study and Chairman of the Liver Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO), pointed out: “Unlike the epidemiology of liver cancer in Europe and the United States, approximately 77% of liver cancer cases in China are attributable to hepatitis B virus (HBV) infection. These cases are characterized by underlying liver disease, insidious onset, atypical symptoms, therapeutic challenges, and poor prognosis. Most patients are diagnosed at intermediate or advanced stages, thereby losing the opportunity for surgery or other local treatments; even when surgery or other local therapies are feasible, recurrence and metastasis are common. Therefore, there is an urgent clinical need for effective innovative drugs and treatment regimens to overcome this dilemma. Encouragingly, in the IMbrave150 trial and its extension studies, the Chinese subgroup, comprising 194 Chinese patients, achieved more favorable outcomes than the global population. This combination therapy/regimen, representing a significant breakthrough, has finally been approved in China, which will undoubtedly benefit a vast number of liver cancer patients. This is indeed a cause for celebration!”

Zhou Hong, President of Roche China: “As a novel therapeutic approach with transformative significance for the treatment landscape of liver cancer, the ‘A+T’ combination therapy has garnered widespread attention and recognition. The approval of Tecentriq® for the indication of hepatocellular carcinoma in China will provide a new treatment option for patients unfortunately afflicted with this highly aggressive cancer who currently have limited therapeutic choices, thereby better addressing the unmet needs in the field of liver cancer treatment. Furthermore, leveraging its innovative portfolio spanning from diagnosis to treatment, Roche aims to collaborate with partners to make concerted efforts across multiple domains—including disease awareness, diagnostic testing, treatment, and monitoring—to curb the spread of chronic liver disease and ultimately achieve the goal of preventing and curing hepatocellular carcinoma.”

Responsible Editor: Liuli

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