BeyondSpring (NASDAQ:BYSI) announced that the Phase 3 portion of its Study 105 evaluating its lead asset, Plinabulin, in patients treated with docetaxel chemotherapy has met its primary endpoint of non-inferiority versus Neulasta for the duration of severe first-cycle neutropenia.
Plinabulin was compared head-to-head with Neulasta, each as single agents.
Based on the results from the Phase 3 trial, as well as recently-released top line data from the Phase 2 portion of Study 106, BeyondSpring now has the necessary data to submit an NDA to the China FDA or National Medical Products Administration (NMPA) for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia (CIN).
The company is also on track to submit an NDA to the U.S. FDA for the treatment of CIN. Both submissions will be for broad claims for the treatment of CIN in terms of chemotherapy and cancer types.
“Our Study 105 Phase 3 data with Plinabulin as a single agent compares well with Neulasta as a single agent for the prevention of CIN,” Dr. Douglas Blayney, principal investigator for BeyondSpring’s CIN development program and Prof. of Medicine at Stanford University School of Medicine.
“Single agent Plinabulin had a superior product profile in regard to bone pain, thrombocytopenia protection, and a favorable, non-immunosuppressive phenotype in Study 105 Phase 2 data,” he added.
Dr. Blayney said the collective data demonstrate Plinabulin’s “profile as an effective CIN prevention, with a superior product profile.”
