China NMPA Approves Roches Tecentriq In Combo With Avastin To Treat People With Most Common Form Of Liver Cancer

Roche announced that the China National Medical Products Administration (NMPA) has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“This approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changing the treatment landscape for this aggressive disease”, said Levi Garraway, M.D, Ph.D, Roche's chief medical officer and head of Global Product Development. “With almost half of the world’s hepatocellular carcinoma cases diagnosed in China, this approval marks a major advance for Chinese patients.”“In China, primary liver cancer ranks as the fourth most common malignancy and is the second leading cause of cancer death. With most patients diagnosed at the intermediate and advanced stages where surgery or other locoregional therapies are not an option, there is an urgent need for effective treatments for unresectable HCC”, said Prof. Shukui Qin, Leading Principal Investigator of the IMbrave150 study in China and Chairman of the Liver Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO). “The IMbrave150 study demonstrated that the combination of Tecentriq and Avastin in this setting can significantly improve outcomes for patients. It is truly gratifying news that the combination is now approved in China and gives a new option to Chinese liver cancer patients.”Liver cancer is one of the most common cancers in China, accounting for nearly 400,000 diagnoses and approximately 368,000 deaths every year, equivalent to over 1,000 per day. Only 20% of people with HCC in China are diagnosed in the early stages, when curative treatments are still an option. The average 5-year survival rate for people in China with liver cancer is only approximately 15%. Roche is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day stopping chronic liver disease.The approval was based on results of the phase III IMbrave150 study, which included analyses of a cohort of Chinese patients (n=194) from the same study. Data from this cohort were consistent with the global results. Among Chinese patients, Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 56% (hazard ratio [HR]=0.44; 95% CI: 0.25–0.76) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 40% (HR=0.60; 95% CI: 0.40–0.90), compared with sorafenib. Tecentriq and Avastin were generally well-tolerated with manageable toxicities, and the safety profile was consistent with the known safety profiles of the individual medicines and with the underlying disease.In May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy. In addition, in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tecentriq in combination with Avastin for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Tecentriq in combination with Avastin was also recently recommended as a preferred option by the CSCO for the treatment of unresectable HCC, as well as by many clinical practice guidelines globally.Earlier this year, the China NMPA also approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), an area of major unmet need and one that has seen limited advances in treatment until now. The submission was based on the results from the positive phase III IMpower133 study and was the first cancer immunotherapy available in China for the initial treatment of ES-SCLC.IMbrave150 is a global phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy.Hepatocellular carcinoma (HCC), the most common form of liver cancer, is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide. Every year, more than 750,000 people worldwide are diagnosed with HCC, with the majority of cases in Asia and almost half of all cases in China. In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise. HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage. The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens

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