- BeyondSpring (BYSI, Financial) presents promising Phase 2 results of their 303 Study at the 2025 ASCO, showing improved efficacy in metastatic NSCLC patients.
- The study reports a median progression-free survival (PFS) of 6.8 months and a disease control rate of 77.3%.
- Treatment with Plinabulin, pembrolizumab, and docetaxel demonstrated a 15-month overall survival rate of 78%.
BeyondSpring Inc. (BYSI), a clinical-stage biopharmaceutical company, has announced positive interim data from their Phase 2 303 Study during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study evaluates the effectiveness of a triplet regimen comprising Plinabulin, pembrolizumab, and docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) who have progressed after first-line PD-1/L1 inhibitors.
The trial enrolled 47 patients and demonstrated a median progression-free survival (PFS) of 6.8 months, which is nearly double the standard of care with docetaxel alone. Additionally, the disease control rate (DCR) was recorded at 77.3%, indicating a substantial clinical benefit for the majority of participants.
In terms of overall survival, a 15-month rate of 78% was observed, with the median overall survival not yet reached at the time of data cut-off. Despite the notable efficacy, 51.1% of patients experienced grade 3 or higher treatment-related adverse effects, predominantly gastrointestinal side effects, and transient hypertension, with no treatment-related fatalities reported.
The study highlights Plinabulin's potential as a first-in-class tubulin binder, capable of overcoming acquired resistance to checkpoint inhibitors via its dual innate and adaptive immune mechanism. The results suggest significant promise for NSCLC patients who have developed resistance to first-line immunotherapy, providing hope for a new therapeutic path in managing this critical unmet need.
