First Patient Treated in Phase III Study: Cadonilimab vs. Tislelizumab Plus Chemotherapy for PD-L1 Negative NSCLC

Akeso Inc. has initiated a pivotal Phase III clinical trial, marking a significant step in advancing cancer treatment. The study involves the use of Cadonilimab, a dual-action PD-1/CTLA-4 antibody, in combination with chemotherapy. This approach is being compared to the standard PD-1 antibody, Tislelizumab, also paired with chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC) patients who are PD-L1 negative, as indicated by a PD-L1 TPS of less than 1% (NCT05990127).
Lung cancer remains a leading cause of mortality worldwide, with a significant portion of NSCLC patients exhibiting PD-L1 negative status. Despite the prevalence, current immunotherapies paired with chemotherapy offer limited survival advantages for this group. There is, therefore, an urgent need for innovative treatments to improve patient outcomes.
Cadonilimab has shown promise in offering a higher efficacy and lower toxicity profile compared to single-agent PD-1/PD-L1 therapies. It has demonstrated clinical benefits for NSCLC patients with PD-L1 negative expression. Additionally, the drug's combination therapy has proven effective as a first-line treatment for advanced gastric and cervical cancers, providing substantial survival benefits regardless of PD-L1 expression levels. Notably, it has shown strong anti-tumor activity even in patients with low or no PD-L1 expression.
Akeso is optimistic that Cadonilimab will maintain its advantages in treating PD-L1 negative NSCLC, potentially establishing itself as a next-generation immunotherapy for advanced NSCLC patients. The company's forward-thinking approach aims to overcome the limitations of current immunotherapies and revolutionize cancer treatment options. This clinical trial represents a critical milestone in the development of more effective therapies for patients in need.