ARTICLE | Clinical News

BeyondSpring reports Phase II data for plinabulin to prevent chemotherapy-induced neutropenia

February 16, 2018 1:10 PM UTC

BeyondSpring Inc. (NASDAQ:BYSI) reported top-line data from 55 patients with advanced or metastatic non-small cell lung cancer (NSCLC) who failed platinum-based therapy in the Phase II portion of the Phase II/III Study 105 (Protective-1) to prevent docetaxel chemotherapy-induced neutropenia showing that the incidence of grade 4 neutropenia was 15% in patients who received 20 mg/m2 IV plinabulin (BPI-2358) vs. 14% in patients who received Neulasta pegfilgrastim. Additionally, the 20 mg/m2 dose of plinabulin was non-inferior to Neulasta in the duration of severe neutropenia (0.38 vs. 0.14 days). The non-inferiority margin was 0.65 days. The company also said it established the recommend Phase III dose of plinabulin as 20 mg/m2, thereby meeting the Phase II portion’s primary objective. Data were presented at the ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco.

Patients in Phase II portion of the double-blind, U.S. trial received docetaxel in combination with Neulasta on days two and six or a single dose of 5, 10 or 20 mg/m2 IV plinabulin. BeyondSpring said it has started preparations to advance into the Phase III portion of the trial, which is slated to enroll 150 patients with breast cancer, NSCLC or prostate cancer. The company expects to report final Phase II data this half and interim Phase III data next half...