PROTECTIVE-2 Phase III study of plinabulin + pegfilgrastim met the primary endpoint in neutropenia.- BeyondSpring

BeyondSpring announced positive topline data from its PROTECTIVE-2 Phase III 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. The PROTECTIVE-2 Phase III 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). In the 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 = 0.0015. In key secondary endpoints the duration of profound neutropenia Cycle 1 (ANC < 0.1 x 109 cells/L): p = 0.0004, and according to literature, profound neutropenia leads to 80% patient death in first week of infection1, and 48% febrile neutropenia, or FN, and 50% infection. According to safety data there was a Lower Grade 4 adverse event (AE) frequency (58.6%) for combination compared to 80.0% in pegfilgrastim monotherapy.