Innovative T+A Therapy Included in China's National Guidelines for Primary Liver Cancer Treatment Ahead of IPO Filing

Our Staff Reporter (Tang Wenjia) Recently, the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)," revised from the "Standards for the Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)," has been officially released by the National Health Commission. In this normative document for the diagnosis and treatment of liver cancer, the combination of Atezolizumab and Bevacizumab (referred to as the “T+A” therapy) has been included for the first time as a first-line recommended systemic antitumor therapy for advanced liver cancer, with evidence level 1 and recommendation grade A (the highest level of evidence type and the highest recommendation grade). This therapy breaks the long-standing deadlock of over a decade without breakthroughs in first-line treatments for advanced liver cancer and will benefit more patients in China.

Currently, the "T+A" therapy has been approved in more than 80 countries and regions worldwide for the treatment of advanced unresectable hepatocellular carcinoma and has been recommended as a first-line treatment in several international authoritative oncology clinical guidelines. According to the results of the global Phase III, multicenter, open-label clinical trial IMbrave150, compared with the previous standard treatment, the "T+A" therapy significantly reduces the risk of death and disease progression, and the time to deterioration in patient-reported quality of life and functioning is better than that of the previous standard treatment. These results were published in The New England Journal of Medicine on May 14, 2020. Based on these findings, China's National Medical Products Administration (NMPA) officially approved Roche’s "T+A" therapy in October 2020 for patients with unresectable hepatocellular carcinoma who have not received prior systemic treatment.

It is reported that primary liver cancer is the fourth most common malignant tumor in China and the second leading cause of cancer-related deaths, posing a serious threat to the health of the Chinese population. While China accounts for 18.4% of the global population, it bears 55.4% of new liver cancer cases and 53.9% of deaths annually, equivalent to over 1,000 patients being diagnosed with liver cancer every day. Currently, the five-year survival rate for Chinese patients is only about 12.2%, leaving many in urgent need of new therapies to regain hope.

In order to standardize the clinical diagnosis and treatment of primary liver cancer in China and further improve the overall efficacy of liver cancer treatment, the former Chinese Ministry of Health organized a multidisciplinary team of experts to conduct extensive research and discussion, and released the "Standard for Diagnosis and Treatment of Primary Liver Cancer (2011 Edition)" in 2011. Subsequently, the expert committee responsible for drafting the standard, led by Fan Jia, an academician of the Chinese Academy of Sciences and president of Fudan University's Zhongshan Hospital, revised the document in 2017, 2019, and 2021.

As the chairman of the expert committee, Academician Fan Jia stated that the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" aims to promote and achieve the goal of increasing the 5-year survival rate of liver cancer patients by 15% as outlined in the "Healthy China 2030" Plan. It represents the highest level of liver cancer diagnosis and treatment in China, incorporates the latest and highest-level evidence-based medical evidence, emphasizes the importance of early screening, early diagnosis, and early treatment, and advocates paying attention to the psychological well-being of patients and their families beyond treatment. The guidelines are rigorous, scientific, practical, popularizable, and operable.

As the Deputy Chairman of the Expert Committee, Vice President of the Chinese Society of Clinical Oncology (CSCO), and the leading Chinese researcher of the IMbrave150 study, Professor Qin Shukui stated that approximately 77% of liver cancer cases in China are caused by hepatitis B virus infection. These cases are often associated with underlying liver disease, insidious onset, atypical symptoms, challenging treatment, and poor prognosis. The majority of patients are initially diagnosed at an advanced stage, losing the opportunity for surgery or other localized treatments; even if surgery or localized treatment is possible, recurrence and metastasis are common. Therefore, there is an urgent clinical need for effective innovative drugs and treatment regimens to overcome these challenges. The "T+A" immunotherapy combination offers a novel mechanism of action and has been extensively proven through large-scale clinical trials to significantly reduce the risk of death in patients with advanced unresectable hepatocellular carcinoma when used as a first-line treatment.

"It is exciting that in the IMbrave150 trial and its extension, the Chinese subgroup, consisting of 194 Chinese patients, achieved better efficacy than the global population. It is well-deserved to be listed as a first-line recommendation for systemic treatment of advanced hepatocellular carcinoma in the new edition of the guidelines. We look forward to more patients achieving longer survival and better quality of life," said Qin Shukui.