BeyondSpring Inc. reported that the Asian subset of its global Phase 3 DUBLIN‑3 study, which enrolled 488 EGFR‑wild‑type non‑small‑cell lung cancer patients, demonstrated a statistically significant overall survival advantage for the plinabulin plus docetaxel combination versus docetaxel alone. The median overall survival was 10.8 months for the DP arm compared with 8.8 months for the docetaxel arm, yielding a hazard ratio of 0.81 (p = 0.0426).
The safety profile was equally compelling: grade 4 neutropenia occurred in only 3.9 % of patients receiving plinabulin plus docetaxel, versus 26.5 % in the docetaxel‑only group (p < 0.0001). The dramatic reduction in severe neutropenia suggests that plinabulin improves chemotherapy tolerability, potentially allowing patients to receive full‑dose treatment and maintain dose intensity.
BeyondSpring’s CEO, Lan Huang, said the Asian data reinforce the global evidence published in Lancet Respiratory Medicine and strengthen the case for a confirmatory Phase 3 study. The company plans to leverage the results for regulatory filings in China and other markets, positioning plinabulin as a potential new standard of care for this patient population. The findings also support the company’s partnership with Jiangsu Hengrui Pharmaceuticals for commercialization in Greater China and its Fast‑Track designation from the FDA for neutropenia prevention.
Financially, BeyondSpring reported a net loss of $4.944 million for Q3 2025, an improvement from the $4.573 million loss in Q3 2024, and a nine‑month net loss of $6.2 million versus $6.9 million in the same period last year. Cash reserves increased, giving the company a stronger runway to fund ongoing clinical development and regulatory activities.
The announcement triggered a robust market reaction: pre‑market trading volume surged to 463.8 times the average, and the stock gained approximately 4.6 %. Investors cited the survival benefit and the marked safety improvement as key drivers, reflecting confidence that plinabulin could capture a sizable share of the EGFR‑wild‑type NSCLC market.
Lan Huang added, “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, 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.”
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