Plinabulin shows superior quality of life over pegfilgrastim in a head-to-head comparison trial for the prevention of neutropenia.- BeyondSpring Inc.

BeyondSpring Inc. has announced the results of its head-to-head clinical trial for Study BPI-2358-105, accepted as an abstract titled, �Quality of Life (QoL) in Advanced NSCLC Patients Treated with Docetaxel and with Either Plinabulin or Pegfilgrastim for the Prevention of Neutropenia.� The poster (Abstract No. 2513) will be presented during the IASLC World Conference on Lung Cancer in Barcelona, Spain on September 8, 2019 from 9:45 a.m. - 6:00 p.m. local time.

In the Phase II portion of the Phase II/III study, a multicenter, randomized double-blind trial, all patients received docetaxel 75 mg/m2 on Day 1. Patients were randomly assigned one of three Plinabulin doses (5 mg/m2 [n=14], 10 mg/m2 [n=13] or 20 mg/m2 [n=14]) given by IV infusion 30 minutes after chemotherapy over four cycles, or the standard dose (6 mg) of Pegfilgrastim (Neulasta) on Day 2. QoL was assessed with the validated health-related questionnaires before dose on Day 1 of each of the four cycles, prior to the study and at the end of treatment.

Previously, BeyondSpring reported in its Phase III study that Plinabulin at 20 mg/m2 or a 40 mg fixed dose � which is the commercial dose level for its intended NDA � has equal protection against severe chemotherapy-induced neutropenia (CIN) in comparison to Pegfilgrastim. BeyondSpring�s latest abstract reports that the 20 mg/m2 Plinabulin dose demonstrated a significant improvement in the QoL over four treatment cycles for global health status (p-value < 0.0001), symptom scale (p-value < 0.009) and summary score (p-value < 0.02). Moreover, there were significant improvements in the QoL of patients for fatigue (p-value <0.03), pain p-value><0.03) and insomnia p-value><0.05). plinabulin in contrast to pegfilgrastim and other g-csfs does not produce bone pain which remains an unaddressed patient complaint with the use of pegfilgrastim monotherapy.>

�We measured patient reported outcomes (PRO) in our study, as PRO are increasingly recognized as important and valid by patients, regulatory agencies and payers. While this analysis is exploratory, these preliminary results are statistically and clinically significant and indicate improvements with Plinabulin in the QoL for patients being treated with docetaxel for advanced non-small cell lung cancer in addition to protecting against CIN,� said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring�s CIN development program and Professor of Medicine at the Stanford University School of Medicine, who will be presenting the data at the conference.