Business
BeyondSpring Announces Positive Topline Results from its PROTECTIVE-2 Phase 3 Registrational Trial of Plinabulin in Combination with Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia
Study met primary endpoint showing statistically significant improvement in rate of prevention of Grade 4 neutropenia in Cycle 1, p=0.0015Study met
About this update from Beyondspring, Inc.
[{"type":"text","content":"Study met primary endpoint showing statistically significant improvement in rate of prevention of Grade 4 neutropenia in Cycle 1, p=0.0015Study met statistically significant improvement in key secondary endpoints, including DSN Cycle 1 D1-8, DSN Cycle 1, and Mean ANC Nadir Cycle 1Plinabulin in combination with pegfilgrastim, a Breakthrough Designation therapy, is believed to be the first product candidate to show improvement over standard of care (G-CSF monotherapy) for chemotherapy-induced neutropenia (CIN), a complication which affects as many as 440,000 chemotherapy patients in the U.S. annuallyConference call and webcast to discuss results will be held today at 8:30 a.m. ET NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced positive topline data from its PROTECTIVE-2 Phase 3 registrational study showing that plinabulin in combination with pegfilgrastim met the primary endpoint with statistically significant improvement in the rate of prevention of Grade 4 neutropenia in Cycle 1 (31.5% vs 13.6%, p=0.0015), as well as achieving statistical significance in all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir.\n The PROTECTIVE-2 Phase 3 study is a double-blind, active-controlled, global study that enrolled a total of 221 patients. Patients in the trial were treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose). The primary efficacy endpoint was rate of prevention of Grade 4 neutropenia. Plinabulin in combination with pegfilgrastim showed a statistically significant improvement compared to pegfilgrastim alone, with topline data summarized below. Data from all 221 patients were analyzed (combination arm n=111, pegfilgrastim arm n=110). Primary endpoint (Rate of prevention of Grade 4 neutropenia): 31.5% combo therapy vs. 13.6% pegfilgrastim monotherapy, 95% CI 17.90 (7.13, 28.66), p = 0.0015Key secondary endpoints:- DSN Cycle 1 Day 1-8 (ANC Safety data:- Lower Grade 4 adverse event (AE) frequency (58.6%) for combination compared to 80.0% in ...