Junshi Biosciences: Phase 3 Toripalimab-Bevacizumab Study for Advanced Hepatocellular Carcinoma Meets Primary Endpoint

Shanghai Junshi Biosciences Co., Ltd, a prominent biopharmaceutical company, recently announced positive outcomes from their phase III clinical trial (HEPATORCH study) involving toripalimab combined with bevacizumab for treating advanced hepatocellular carcinoma (HCC). The study, a multi-center, open-label, and active-controlled trial, successfully met its primary endpoints of progression-free survival (PFS) and overall survival (OS). Following these promising results, Junshi Biosciences intends to submit a new drug application to regulatory authorities soon.

Liver cancer is among the most prevalent malignant tumors globally, with hepatocellular carcinoma being its most common form, constituting about 90% of cases. According to the GLOBOCAN Report of 2022, there were 866,000 new liver cancer cases worldwide, resulting in 759,000 deaths. China, in particular, faces a severe burden from liver cancer, with 368,000 new cases and 317,000 deaths in 2022, representing significant percentages of the global figures. The majority of liver cancer diagnoses occur at advanced stages, contributing to a median overall survival of about 10 months and a 5-year survival rate of around 12%. Recent advancements in immunotherapy-based combination treatments have begun to shift the treatment paradigm for advanced liver cancer, offering potential for more effective treatments.

The HEPATORCH study primarily aimed to compare the efficacy and safety of toripalimab combined with bevacizumab against the standard treatment with sorafenib for patients with unresectable or metastatic HCC. The results demonstrated that the combination therapy significantly extended PFS and OS and enhanced secondary metrics such as the objective response rate and time to progression. The safety profile of toripalimab aligned with known risks, with no new safety concerns detected. Detailed findings from this study will be shared at an upcoming international academic conference.

Professor Jia Fan, a leading investigator for the study and President of Zhongshan Hospital, emphasized the importance of the combination therapy involving immune checkpoint inhibitors and anti-angiogenesis targeted treatments for advanced liver cancer. He highlighted that the HEPATORCH study's success could introduce a new, more effective treatment option for these patients. Toripalimab, already approved in the US, represents an important milestone as the first innovative biologic drug independently developed in China to receive FDA approval, reflecting international recognition of its quality.

Dr. Jianjun Zou, CEO of Junshi Biosciences, expressed the company’s commitment to addressing the high incidence and mortality rates of hepatocellular carcinoma in China. He reiterated Junshi Biosciences' mission to provide world-class, reliable, and affordable innovative drugs. The study's findings demonstrated toripalimab's significant impact on survival rates for advanced HCC patients. Dr. Zou stated that the company would continue to engage with regulatory bodies to expedite the approval process, aiming to benefit more patients with advanced liver cancer.

Toripalimab, an anti-PD-1 monoclonal antibody, has been developed to block PD-1 interactions with its ligands, thereby enhancing the immune system's ability to target and destroy tumor cells. Junshi Biosciences has conducted over forty clinical studies globally, involving more than fifteen indications, including various types of cancer. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing and is currently used for multiple cancer indications, several of which are included in the National Reimbursement Drug List.

Founded in December 2012, Junshi Biosciences is dedicated to the discovery and commercialization of innovative therapeutics across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases. The company has a robust R&D pipeline with over 50 drug candidates and has introduced four innovations to the market, including toripalimab. During the COVID-19 pandemic, Junshi Biosciences also developed therapies for prevention and treatment. The company employs around 3,000 people across its offices in the United States and China, underscoring its global commitment to advancing healthcare.