Study met the primary endpoint showing statistically significant improvement in overall survival (OS) for the combination (DP) vs. docetaxel (D).
Study met key secondary endpoints showing statistically significant improvement for DP vs. D in ORR, PFS, and 24- and 36-month OS rates, significant reduction in incidence of Grade 4 neutropenia and clinically meaningful relative improvement in Q-TWiST of 18.4%.
In PD-1/PD-L1 exposed patients, DP had longer OS benefit vs. D (HR = 0.68); and the 24 M OS rate in the combination was triple that of docetaxel (p=0.0026).
BeyondSpring plans to seek U.S. FDA and China NMPA approval for plinabulin in combination with docetaxel in 2nd/3rd line NSCLC based on the demonstrated clinical benefit and safety profile, with an anticipated NDA filing in 1H 2022.
More detailed data will be presented live at 8:10 a.m. ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m. ET today. Dial-in: 877-451-6152, conference ID#: 13723041
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