FDA on board with endpoint change in study of BeyondSpring’s Plinabulin

BeyondSpring (BYSI +4.5%) announces that the FDA has signed off on changing the primary endpoint of its Phase 3 clinical trial, Study 106, evaluating lead drug Plinabulin for the prevention of chemo-induced neutropenia (abnormally low levels of a type of white blood cell called neutrophils).

The new primary endpoint is the rate of prevention of Grade 4 (life-threatening) neutropenia rather than the duration, the former endpoint, compared to Amgen’s (AMGN -0.2%) Neulasta (pegfilgrastim) (G-CSF therapy).

According to lead investigator Dr. Douglas Blayney, Professor of Medicine at Stanford Medical School, the new endpoint more accurately represents clinical benefit.

https://seekingalpha.com/news/3566086-fda-on-board-endpoint-change-in-study-of-beyondsprings-plinabulin