Roche's 'T+A' Immune Combination Therapy Granted Priority Review in China, Poised to Become First Global First-Line Immunotherapy for Unresectable Hepatocellular Carcinoma

Today, Roche announced that the China National Medical Products Administration (NMPA) has officially granted priority review status to the innovative cancer immunotherapy Tecentriq® (generic name: atezolizumab) in combination with Avastin® (generic name: bevacizumab) (hereinafter referred to as “T+A”) for the first-line treatment of advanced unresectable hepatocellular carcinoma. In January this year, Roche submitted the marketing application for this therapy. The “T+A” immuno-combination regimen is poised to become the first approved first-line immuno-combination therapy worldwide for advanced unresectable hepatocellular carcinoma.

First Breakthrough in Over a Decade: “T+A” Immunotherapy Combination Offers Greater Benefits for Chinese Liver Cancer Patients

The China National Medical Products Administration (NMPA) has granted priority review status to the “T+A” immunotherapy combination for the first-line treatment of advanced unresectable hepatocellular carcinoma, primarily based on the results of the global, multicenter, Phase III IMbrave150 clinical trial. The IMbrave150 study is the first in over a decade to demonstrate an improvement in overall survival (OS) among patients with unresectable hepatocellular carcinoma who had not previously received systemic therapy. Both overall survival and progression-free survival showed statistically and clinically significant improvements compared to the current standard of care, making the “T+A” immunotherapy combination undoubtedly an exciting breakthrough in the field of liver cancer treatment.

Breakthrough Beyond Existing Standard Regimens with Significant Clinical Benefit: Data from the Chinese subgroup of the Phase III IMbrave150 trial, presented at the 2020 Liver Cancer Summit hosted by the European Association for the Study of the Liver (EASL), demonstrated that in Chinese patients, the “T+A” immunotherapy combination regimen significantly reduced the risk of death by 56% compared with the standard-of-care sorafenib regimen (stratified HR for OS=0.44, 95% CI: 0.25–0.76) and significantly reduced the risk of disease progression or death by 40% (stratified HR for PFS=0.60, 95% CI: 0.40–0.90). The improvement in overall survival (OS) was more pronounced than that observed in the previously reported global data from the Phase III IMbrave150 trial.

Significant Benefits and Controllable Safety in the Chinese Population: The safety profile of the “T+A” immunotherapy combination in the Chinese population is consistent with that observed in the global population and aligns with the known safety profiles of both drugs. No new safety signals were identified in the study data. The “T+A” immunotherapy combination is well tolerated in the Chinese population.

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. There are 750,000 new cases of hepatocellular carcinoma globally each year, with the majority occurring in Asia and nearly half in China. According to data from the 2015 Chinese Cancer Registry Annual Report, there are approximately 370,000 new cases of hepatocellular carcinoma in China annually, resulting in 326,000 deaths.

Professor Qin Shukui, the leading principal investigator (PI) in China for the international IMbrave150 study and Chairman of the Liver Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO), pointed out: “China has high incidence and mortality rates for hepatocellular carcinoma (HCC). Due to the frequent presence of underlying liver disease, insidious onset, atypical symptoms, challenging treatment, and poor prognosis, most patients are already at an intermediate or advanced stage at diagnosis, having lost the opportunity for surgery or other local therapies. Even when surgery or other local treatments are feasible, recurrence and metastasis are common. Currently, the median overall survival for patients with advanced HCC is approximately 10 months, with a 5-year survival rate of only around 12%. Therefore, there is an urgent clinical need for safe and effective innovative therapeutic drugs and regimens to overcome this dilemma. The ‘T+A’ immunotherapy combination, featuring a novel mechanism of action, has been fully demonstrated in large-scale clinical trials to significantly reduce the risk of death and markedly improve quality of life as a first-line treatment for patients with unresectable advanced HCC, which is truly gratifying. We look forward to the early approval of this groundbreaking combination therapy/drug regimen in China, to benefit patients with liver cancer.”

Priority Review for Innovative Regimens: Immunotherapy Combination Brings New Hope to Chinese Patients

In 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to the “T+A” immunotherapy combination (Tecentriq® plus Avastin®) for the treatment of hepatocellular carcinoma. In 2020, Roche submitted a marketing application to China’s National Medical Products Administration for the use of the “T+A” immunotherapy combination (Tecentriq® plus Avastin®) as first-line treatment for advanced unresectable hepatocellular carcinoma, and the application received priority review status. This milestone underscores the Chinese government’s determination and achievements in accelerating the review and approval of new drugs to address unmet clinical needs of patients.

Zhou Hong, President of Roche China, stated, “Guided by our commitment to ‘acting in the best interests of patients first,’ Roche has been dedicated to continuously introducing innovative medicines into therapeutic areas of urgent need for patients in China. The recent approval of Tecentriq® for small cell lung cancer in China, along with the priority review status granted to the ‘Atezolizumab + Bevacizumab’ immunotherapy combination, fully demonstrates the government’s determination to promote the development of the pharmaceutical industry. Looking ahead, Roche will continue to increase its investment in China, actively support relevant reforms, and benefit a broader population of Chinese cancer patients.”