BYSI - BeyondSpring's plinabulin combo meets primary endpoint in neutropenia trial

BeyondSpring (BYSI) +5% in premarket after announcing topline data from its PROTECTIVE-2 Phase 3 study showing that plinabulin in combination with Amgen's Neulasta (pegfilgrastim) met the primary endpoint with statistically significant improvement in the rate of prevention of Grade 4 (life threatening) chemo-induced neutropenia ((CIN)) in Cycle 1, as well as achieved statistical significance in all key secondary endpoints.Results showed rate of prevention of 31.5% with the combo therapy vs. 13.6% pegfilgrastim monotherapy.On the safety front, the plinabulin/pegfilgrastim combo showed lower grade 4 adverse event frequency (58.6%) compared to 80% in pegfilgrastim monotherapy.The company is working on the marketing application submission which is expected in Q1 of 2021. In addition to Plinabulin being developed as a treatment option for the prevention of CIN, it is also being investigated as a direct anticancer agent in a Phase 3 trial of plinabulin + docetaxel for non-small cell lung cancer, with final data read-out in 1H 2021.The company

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BeyondSpring's plinabulin combo meets primary endpoint in neutropenia trial