- Study met primary endpoint showing statistically significant improvement in overall survival (OS) for the combination vs. docetaxel.
- Study met key secondary endpoints showing statistically significant improvement for the combination against docetaxel alone in ORR, PFS, and 24- and 36-month OS rates, and significant reduction in incidence of Grade 4 neutropenia.
- BeyondSpring plans to seek U.S. FDA and China NMPA approval for plinabulin in combination with docetaxel in NSCLC based on the demonstrated clinical benefit and safety profile.
- Full data is planned to be presented at upcoming medical conference; The company will host a call at 8:30 a.m. ET today. Dial-in: 877-451-6152, conference ID# 13722298
NEW YORK, Aug. 04, 2021 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, announced today the positive topline data of DUBLIN-3 registrational trial in plinabulin in combination with docetaxel to treat 2nd and 3rd line NSCLC (EGFR wild type) compared to docetaxel alone (n=559). Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. The data released today showed that compared to docetaxel alone, the combination met the primary endpoint of increasing overall survival (mean OS, p = 0.03; OS log rank, p