In the Phase 2 portion of the Phase 2/3 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 3 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.
“PRO are equally as important as validated clinical outcomes, and with Plinabulin we have created a treatment option that is effective for CIN prevention and improves the QoL for very sick patients,” added Dr. Ramon Mohanlal, Chief Medical Officer and Executive Vice President, Research and Development, BeyondSpring. “Our CIN program has now advanced into Phase 3, and as a company, we are preparing for the submission of NDAs in both China and the U.S. for CIN in the coming months.”
Source: Company Press Release