BeyondSpring (NASDAQ: BYSI) plans to present positive data in 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” at the IASLC World Conference on Lung Cancer in Barcelona on Sept. 8, 2019.
In the Phase 2 portion of the company’s BPI-2358-105 Phase 2/3 study, QoL was assessed with validated health-related questionnaires prior to the study and at the end of treatment.
BeyondSpring previously 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), compared with 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, symptom scale and summary score. In addition, there were significant improvements in the QoL of patients for fatigue, pain and insomnia.
Plinabulin, in contrast to Pegfilgrastim and other granulocyte-colony stimulating factors, does not produce bone pain, which remains an unaddressed patient complaint with the use of Pegfilgrastim monotherapy.
“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,” Dr. Douglas Blayney, global principal investigator for BeyondSpring’s CIN development program and Professor of Medicine at the Stanford University School of Medicine, said in a statement.
Dr. Ramon Mohanlal, CMO and EVP of R&D for BeyondSpring, said patient reported outcomes are equally as important as validated clinical outcomes. “With Plinabulin we have created a treatment option that is effective for CIN prevention and improves the QoL for very sick patients,” he added.
“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.”
