IMMUNEONCO-B (01541) announced that the group has submitted an application to the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China for a Phase III clinical trial of IMM2510 for the treatment of immunotherapy (IO) resistant non-small cell lung cancer (NSCLC). The company has recently submitted two Phase III registration clinical trials targeting different types of lung cancer.
Recent Phase I study data presented at the 2025 World Conference on Lung Cancer demonstrated that IMM2510 achieved an objective response rate (ORR) of 35.3% and a disease control rate (DCR) of 76.5% (13/17) in 17 evaluable patients with advanced squamous non-small cell lung cancer (SQ-NSCLC) who had previously received immunotherapy. The median duration of response (DoR) was 7.59 months (95% CI: 4.07-NA), and the median progression-free survival (PFS) was 9.4 months (95% CI: 1.87-NA).
Based on these results, the company plans to further validate the efficacy and safety of IMM2510 through Phase III clinical trials, aiming to provide more effective treatment options for lung cancer patients.