Why Are BeyondSpring's Shares Plunging Today?

BeyondSpring Pharmaceuticals Inc BYSI shared the final intention-to-treat (ITT) dataset from its DUBLIN-3 Phase 3 trial of plinabulin.
The trial evaluated plinabulin combined with docetaxel vs. docetaxel alone for 2nd/3rd line non-small cell lung cancer (NSCLC) patients with EGFR wild type.
The data were presented at the European Society for Medical Oncology Congress (ESMO21) 2021 failed to impress.
The mean overall survival (OS) for the combination therapy was 15.08 months vs. 12.77 months for docetaxel. The median OS was 10.5 months versus 9.4 months, and the overall response rate was 12.2% vs. 6.7%.
The mean and median progression-free survival was 6 months vs. 4.4 months and 3.6 months vs. 3 months, respectively.
24 Month OS rate (22.1% vs. 12.5%); 36 Month OS rate (11.7% vs. 5.3%) and 48 Month OS rate (10.6% vs. 0%).
In PD-1/PD-L1 exposed patients, the plinabulin combo had longer OS benefit vs. docetaxel; and the 24 M OS rate in the combination was triple that of docetaxel.
BeyondSpring plans to seek FDA and China NMPA approval for the plinabulin combo with an anticipated marketing filing in 1H of 2022.
Related: BeyondSpring Presents New Plinabulin Data At ESMO Congress In Chemotherapy-Induced Neutropenia.
Price Action: BYSI shares are down 30.80% at $15.86 during the market session on the last check Monday.
Check out our coverage of the European Society for Medical Oncology Congress (ESMO21).