Wuhan YZY Biopharma Co., Ltd. (Stock Code: 2496) presented interim results from a randomized, multi-center, open-label Phase II clinical study (M70103) of its bispecific antibody candidate M701 at the European Society for Medical Oncology Congress 2025. The trial focuses on malignant pleural effusion (MPE) caused by advanced non-small cell lung cancer (NSCLC).

According to the announcement, the study enrolled 54 advanced NSCLC patients with symptomatic MPE who had failed at least one line of systemic treatment. Participants were randomly assigned 1:1 to receive either intrapleural M701 (experimental group) or intrapleural cisplatin (control group). As of March 7, 2025, median puncture-free survival (PuFS), the study’s primary endpoint, was 130 days in the M701 group and 85 days in the control arm, with a hazard ratio of 0.80 (p=0.542). Notably, patients without driven gene mutations or those with prior intrapleural chemotherapy derived significant benefit, as reflected by longer PuFS and favorable improvements in symptoms such as dyspnea.

Regarding safety, treatment-related adverse events were reported at 3.7% in the M701 group versus 10% in the cisplatin group. Only one serious adverse event (Grade 2 fever) in the experimental arm was associated with M701. Flow cytometry data showed a notable reduction in EpCAM+ CD45- tumor cells in pleural effusions for those receiving M701, aligning with the drug’s T cell-engaging mechanism of action.

The trial remains ongoing, and a pivotal Phase III trial is planned for 2026 in China to further assess M701’s efficacy and safety on a larger scale. M701 is also under clinical development for malignant ascites, with a separate pivotal Phase III trial in progress. The announcement notes that Chia Tai Tianqing Pharmaceutical Group Co. Ltd. holds an exclusive, sublicensable license related to M701’s development, registration, manufacturing, and commercialization in China.