BeyondSpring Announces Asian Results from DUBLIN-3 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
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Should l Buy BYSI?
BeyondSpring announced results from the Asian subset of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer. Dublin-3's global intent-to-treat patient data was published in Lancet Respiratory Medicine in 2024. These new findings were presented by Dr. Baohui Han of Shanghai Chest Hospital at the European Society for Medical Oncology Asia Congress 2025. In this large Asian intent-to-treat cohort, Plinabulin + docetaxel achieved a statistically significant improvement in overall survival compared to docetaxel: DP 10.8 months vs. D 8.8 months, HR 0.81, p=0.0426. In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69 with a median OS benefit of 3 months, highlighting enhanced benefit in patients whose disease biology aligns with Plinabulin's immune-modulating and tumor vasculature-targeting mechanisms. The combination also doubled 2-year and 3-year survival rates, reflecting durable benefit consistent with Plinabulin's first-in-class dendritic-cell maturation mechanism. Plinabulin demonstrated a marked reduction in docetaxel-induced grade 4 neutropenia, while maintaining a favorable tolerability profile. This safety improvement supports better treatment exposure, an important driver of chemotherapy benefit. "These data from nearly 500 Asian patients further strengthen the robust global evidence supporting Plinabulin's potential to become a new standard of care for EGFR wild-type NSCLC," said Dr. Lan Huang, CEO. "The consistent survival benefit, particularly in the mechanism-aligned non-squamous population, together with the marked reduction in severe neutropenia, reflects Plinabulin's first-in-class immune-modulating mechanism and its ability to improve chemotherapy tolerability. These results reinforce our confidence as we advance Plinabulin into a global Phase 3 confirmatory study."
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About BYSI
BeyondSpring Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing therapies to improve clinical outcomes for patients with high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in non-small cell lung cancer (NSCLC) and a range of cancer indications. The Company’s mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering an approach to resensitizing tumors to checkpoint inhibitors. It also has a pipeline of immuno-oncology product candidates, BPI-002 program, which is based on an oral small molecule agent that increases T-cell co-stimulation; BPI-003 program, which is based on a small molecule inhibitor of IKK, a protein kinase, and BPI-004 program, which is focused on a small molecule that induces the production of neo-antigens by tumor cells, allowing tumors containing no immune cells to be infiltrated by the immune system.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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