HONG KONG, March 6, 2024 /PRNewswire/ -- Akeso Inc. ("Akeso", 9926. HK) 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.