BeyondSpring (NASDAQ:BYSI) is the biggest gainer in the pre-market session after announcing positive topline data of DUBLIN-3 trial in plinabulin in combination with docetaxel (DP) to treat 2nd and 3rd line NSCLC (EGFR wild type) compared to docetaxel alone (D) (n=559).
The combination met the primary endpoint of increasing overall survival (OS) (mean OS, p=0.03; OS log rank: p <0.04).
The study also met key secondary endpoints, including significantly improving ORR (p<0.03), PFS (p<0.01) and 24 (DP: 22.1% vs. D: 12.5%; p <0.01) and 36 (DP: 11.7% vs. D: 5.3%; p = 0.04) month OS rates, and significant reduction in the incidence of Grade 4 neutropenia.
No unexpected AE concerns were identified.
“A pre-NDA meeting will be scheduled with the FDA in 2021 to agree on the contents for our NDA, to support a NSCLC indication NDA submission in the first half of 2022,” said Dr. Lan Huang, BeyondSpring’s co-founder, CEO.
The first NDA submission of plinabulin in CIN prevention is under FDA priority review with a PDUFA date of November 30, 2021.
At the time of writing, BYSI stock soared 293% to $37.88 on hefty volue. keep an eye on the stock.