HONG KONG — Akeso Inc. announced the enrollment of the first patient in the registrational Phase III clinical study comparing Cadonilimab (PD-1/CTLA-4 bispecific antibody) combined with chemotherapy versus Tislelizumab (PD-1 antibody) combined with chemotherapy in the first-line treatment for patients with PD-L1 negative (PD-L1 TPS＜1%) non-small cell lung cancer (NSCLC) (NCT05990127).
Lung cancer is a prevalent malignancy with significant global incidence and mortality rates. Retrospective studies conducted both worldwide and in China have revealed that PD-L1 negative expression is observed in up to 48% of patients with driver gene-negative NSCLC. Immunotherapy combined with chemotherapy stands as the first-line standard treatment for these patients. However, current treatment approaches provide limited survival benefits for PD-L1 negative patients. Hence, there exists a pressing clinical imperative for novel treatment modalities to enhance patients’ clinical outcomes.
Compared to PD-1/PD-L1 monoclonal antibodies, PD-1 monoclonal antibody plus CTLA-4 monoclonal antibody combined with chemotherapy provides greater benefits for the PD-L1 negative population. Previous studies have demonstrated that Cadonilimab possesses a “high efficacy, low toxicity” profile and shows clinical efficacy in NSCLC patients with PD-L1 negative expression.
The previous clinical studies have demonstrated that the combination therapy of cadonilimab as a first-line treatment for advanced gastric cancer and advanced cervical cancer provides significant survival benefits for the all-comer patients, irrespective of their PD-L1 expression levels. Furthermore, it exhibits robust anti-tumor effects even in patients with low PD-L1 expression or negative status. This therapeutic approach effectively addresses the limitations of current PD-1/PD-L1 monoclonal antibody immunotherapy and has the potential to reshape the landscape of cancer treatment. Akeso anticipates that Cadonilimab, in the treatment of PD-L1 negative NSCLC population, will continue its unique advantages observed in gastric and cervical cancers, becoming a new generation of efficient immunotherapy regimen for first-line treatment of advanced PD-L1 negative NSCLC patients.
About Akeso, Inc.
Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.
Akeso is actively developing a diverse pipeline of over 50 innovative assets in cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 pivotal/phase III trials ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies.
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