CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).
The study will assess the efficacy of CS1002/SHR-8068 in combination with adebrelimab (an anti-PD-L1 monoclonal antibody) and bevacizumab (the experimental group) compared to sintilimab (an anti-PD-1 monoclonal antibody) combined with bevacizumab (the control group) in terms of objective response rate (ORR) and overall survival (OS) in patients with advanced HCC.
CS1002 is an investigational anti-CTLA-4 monoclonal antibody developed by CStone Pharmaceuticals. Unlike previous CTLA-4 targeted drugs, CS1002 has been tested with various dosing regimens in early development and has shown encouraging efficacy and safety across three indications, validating its potential as a key component in cancer immunotherapy combinations. CTLA-4 is a transmembrane protein encoded by the CTLA-4 gene, which inhibits T-cell activation by binding to its ligands B7.1/B7.2, allowing tumor cells to evade T-lymphocyte attacks. Blocking the CTLA-4 pathway stimulates T-cell activation and proliferation, inducing or enhancing anti-tumor immune responses, offering a novel immunotherapeutic approach for various human cancers.
In November 2021, CStone Pharmaceuticals entered into a strategic collaboration and exclusive license agreement with HengRui Medicine for CS1002 in the Greater China region. Under the terms of the agreement, CStone is eligible to receive an upfront payment and potential milestone payments totaling up to approximately $200 million, as well as double-digit percentage royalties. HengRui Medicine obtained exclusive rights to develop, register, manufacture, and commercialize CS1002 in the Greater China region, while CStone retains the rights to develop and commercialize CS1002 outside of the Greater China region.
In February 2024, data on the safety and efficacy of CS1002 as a monotherapy and in combination with nofazinlimab/CS1003 (an anti-PD-1 monoclonal antibody) for the treatment of advanced/metastatic solid tumors from the first-in-human study were published in the journal “Cancer.” The results showed that CS1002 demonstrated good tolerability and safety as a single agent or in combination with nofazinlimab, providing a solid clinical basis for the further development of CS1002-based combination therapies.
In addition to the Phase III study for HCC, in January 2024, HengRui Medicine received IND approval from the National Medical Products Administration (NMPA) of China to evaluate the efficacy of CS1002/SHR-8068 in combination with adebrelimab and chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).- Flcube.com
