Company announce data from the PROTECTIVE-1 Phase 3 clinical study of plinabulin for prevention of chemotherapy-induced neutropenia (CIN) compared to pegfilgrastim
RCT (n=105) found non-inferiority of single agent plinabulin, a selective immunomodulating microtubule-binding agent, vs single agent pegfilgrastim. Plinabulin is infused 30mins post chemotherapy on day 1 whereas pegfilgrastim is infused on day 2.
Source:
Biospace Inc.
SPS commentary:
In another study (PROTECTIVE-2 Phase 3), the combination of plinabulin and pegfilgrastim was found to be superior to pegfilgrastim alone, which met primary endpoint of prevention of grade 4 neutropenia and key secondary endpoints. The Company has submitted a New Drug Application for plinabulin in combination with pegfilgrastim for the prevention of CIN in the U.S.