By Fineline Cube 
Wuhan YZY Biopharma Co., Ltd. (HKG: 2496) today disclosed interim data from its Phase II clinical trial of the bispecific antibody M701 for the treatment of malignant pleural effusion (MPE) in advanced non‑small cell lung cancer (NSCLC) patients. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2025.
Study Design & Patient Cohort
- Population – 54 NSCLC patients with symptomatic MPE, progressed after ≥ 1 line of systemic therapy.
- Randomization – 1:1 into M701 (26 pts) vs. control (28 pts).
- Control Therapy – Standard cisplatin‑based pleurodesis.
Key Efficacy Endpoints
| Endpoint | M701 | Control | Hazard Ratio (HR) | P‑value |
|---|---|---|---|---|
| Thoracentesis‑Free Survival (TFS) | 130 days (median) | 85 days | 0.80 | 0.542 |
| MPE Objective Response Rate (ORR) (overall) | 72.7 % | 41.7 % | — | — |
| Dyspnea Improvement (≥ 4 weeks) | 98 days sustained | — | — | — |
| EpCAM⁺CD45⁻ Tumor Cells in Pleural Fluid (post‑infusion) | Significant ↓ | No change | — | — |
Sub‑Group Insights
- Driver‑Gene‑Negative Patients – Median TFS not reached vs. 44.5 days; HR < 0.01 (P < 0.001).
- History of Intra‑Thoracic Chemotherapy – Median TFS 253 days vs. 72 days; HR 0.31 (P = 0.076).
- MPE ORR in Sub‑Groups – 72.7 % (M701) vs. 41.7 % (control).
Scientific Significance
- Mechanistic Proof – Flow cytometry demonstrated a marked reduction of EpCAM⁺CD45⁻ tumor cells in pleural fluid after M701 infusion, a change absent with cisplatin.
- Clinical Impact – M701 offers a non‑invasive alternative to repeated thoracentesis, improving patient quality of life and reducing procedural burden.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech