Akeso Announced the First Patient Dosed in Phase III Trial of Cadonilimab(PD-1/CTLA-4) Combined with Chemotherapy versus Tislelizumab Combined with Chemotherapy in First-line Treatment of PD-L1 negative NSCLC

Akeso Inc. announced the enrollment of the first patient in the registrational Phase III clinical study comparing Cadonilimab combined with chemotherapy versus Tislelizumab combined with chemotherapy in the first-line treatment for patients with PD-L1 negative non-small cell lung cancer.

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.

Cision View original content:https://www.prnewswire.com/news-releases/akeso-announced-the-first-patient-dosed-in-phase-iii-trial-of-cadonilimabpd-1ctla-4-combined-with-chemotherapy-versus-tislelizumab-combined-with-chemotherapy-in-first-line-treatment-of-pd-l1-negative-nsclc-302081234.html

SOURCE Akeso, Inc.

Company Codes: HongKong:9926

MORE ON THIS TOPIC