BioCentury
ARTICLE | Clinical News

Plinabulin meets in Phase III for chemotherapy-induced neutropenia

January 11, 2019 5:58 PM UTC

BeyondSpring Inc. (NASDAQ:BYSI) reported interim data on Dec. 6 showing that plinabulin (BPI-2358) met the primary endpoint in the Phase III portion of the Phase II/III Protective-1 trial to treat chemotherapy-induced neutropenia in patients with solid tumors. The company plans to submit NDAs to the FDA and China's National Medical Products Administration (NMPA) in the near future for plinabulin in the indication. The candidate is a halimide-derived tumor vascular disrupting agent (VDA) and ARHGEF2 activator.

On the trial's primary endpoint, plinabulin was non-inferior to Neulasta pegfilgrastim in the duration of chemotherapy-induced neutropenia after the first cycle of chemotherapy. The interim analysis of the double-blind, international trial included 105 patients with advanced breast cancer, hormone-refractory prostate cancer or advanced non-small cell lung cancer (NSCLC) who were treated with docetaxel...