1. BYSI reported significant survival benefit in Asian NSCLC patients. 2. Plinabulin + docetaxel combo improved overall survival to 10.8 months. 3. Marked reduction in severe neutropenia enhances treatment tolerability. 4. Stronger efficacy seen in mechanism-aligned non-squamous subgroup. 5. Results support Plinabulin as a potential new standard of care.
FAQ
Why Bullish?
The announcement of improved survival rates supports investor confidence and could positively influence stock performance.
How important is it?
The trial results indicate Plinabulin's potential effectiveness, which is crucial for BYSI's market performance.
Why Short Term?
Immediate investor reactions to positive study results can influence stock prices quickly, as seen with previous trial results in biopharma.
BeyondSpring Highlights Plinabulin's Survival Benefits at ESMO Asia Congress 2025
FLORHAM PARK, N.J., December 12, 2025 – BeyondSpring Inc. (NASDAQ: BYSI), a pioneering clinical-stage biopharmaceutical company, has announced significant findings from the Asian subset of its Phase 3 DUBLIN-3 trial, which emphasizes the efficacy of Plinabulin combined with docetaxel in improving overall survival in patients with EGFR wild-type non-small cell lung cancer (NSCLC).
Key Findings from the DUBLIN-3 Trial
The results presented by Dr. Baohui Han at the European Society for Medical Oncology (ESMO) Asia Congress 2025 reveal that Plinabulin plus docetaxel (DP) demonstrated a statistically significant overall survival (OS) advantage compared to docetaxel alone (D). In this study, comprising 488 patients, Plinabulin + docetaxel achieved a median OS of 10.8 months versus 8.8 months for docetaxel, resulting in a hazard ratio (HR) of 0.81 (p=0.0426).
Mechanism-Based Subgroup Analysis
In the non-squamous subgroup, which aligns with Plinabulin's immune-modulating properties, the data showed a remarkable HR of 0.69, representing a median OS benefit of 3 months (p=0.0064). This reinforces the potential of Plinabulin to address the unique biological characteristics of these patients.
- 2-Year Survival Rate: Doubled with Plinabulin + docetaxel.
- 3-Year Survival Rate: Also doubled, indicating lasting efficacy.
Safety Profile and Treatment Tolerability
Alongside the survival benefits, the combination of Plinabulin and docetaxel showed a significant reduction in docetaxel-induced grade 4 neutropenia, with incidences of 3.9% for the combination therapy compared to 26.5% for docetaxel alone (p<0.0001). This notable safety advantage highlights Plinabulin's ability to improve tolerability, enabling patients to receive optimal therapeutic exposure, which is critical for chemotherapy efficacy.
Expert Commentary and Future Directions
Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring, stated, “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. The consistent survival benefit, especially in non-squamous populations, combined with the significant reduction in severe neutropenia, underscores Plinabulin's transformative role in cancer treatment.”
Looking ahead, these results will inform the next stages for Plinabulin, as the company prepares to advance into a global Phase 3 confirmatory study.
About Plinabulin and the DUBLIN-3 Study
Plinabulin is recognized as a first-in-class, brain-penetrating small molecule that aids in dendritic cell maturation. With over 700 cancer patients treated, Plinabulin has demonstrated impressive tolerability and sustained anti-cancer benefits across various clinical studies. By functioning as a reversible binder at a unique tubulin pocket, Plinabulin differentiates itself from traditional tubulin agents, enhancing both safety and efficacy.
The DUBLIN-3 study, conducted with 559 patients across multiple centers in the US, China, and Australia, specifically targeted those with EGFR wild-type NSCLC who had progressed following first-line platinum-based therapy. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and duration of response (DoR).
About BeyondSpring
BeyondSpring Inc. (NASDAQ: BYSI) is at the forefront of developing first-in-class therapies targeted at addressing significant unmet medical needs in oncology. Its lead project, Plinabulin, is undergoing late-stage development as an anti-cancer agent not only for NSCLC but also for other indications, showcasing an innovative approach to modulating immune responses against resistant tumors.
For more information, visit BeyondSpring Pharmaceuticals.