Plinabulin in combination with G-CSF is undergoing regulatory review for potential approval in the U.S. and China for the prevention of CIN, with a U.S. PDUFA date of November 30, 2021.
NEW YORK, Sept. 16, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of innovative cancer therapeutics, today announced new positive data on plinabulin from its chemotherapy-induced neutropenia (CIN) prevention program with three poster presentations at the European Society for Medical Oncology (ESMO) 2021 Congress taking place from September 16-21, 2021. Plinabulin, the Company’s first-in-class lead asset, in combination with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN) is currently under U.S. and China regulatory review with an FDA PDUFA date of November 30, 2021. The posters will be made available for viewing on the ESMO website starting on September 16 at 8:30 a.m. CEST and will remain available on the ESMO website throughout the entire duration of the Congress.
“We’re pleased to present additional positive data at this year’s ESMO Congress to show that the Grade 4 neutropenia endpoint is correlated with clinically meaningful endpoints in a meta-analysis with >7000 patients in various cancer and various chemotherapy. This adds to our existing body of data in CIN prevention, a critically important indication for cancer patients,” said Dr. Ramon Mohanlal, executive vice president, R&D, and chief medical officer at BeyondSpring Pharmaceuticals. “Over the last few years, plinabulin has continued to show its potential in preventing this life-threatening side effect of chemotherapy, and we remain committed to bringing this therapy to patients in need globally as we eagerly await November’s PDUFA date.”
A summary of the data can be found below:
Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN). Poster #3574.Ramon Mohanlal, M.D., Ph.D., executive vice president, R&D, chief medical officer, BeyondSpring Pharmaceuticals
- The meta-analysis dataset included data from 36 published world literature (n > 7000) in various cancers and chemotherapy as well as the plinabulin CIN program including all 105 and 106 CIN studies (n=496).
- Correlations of exponential equations between rate of febrile neutropenia (FN), duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir were statistically significant (p7000 patients, the reduction in Gr4N frequency from 86% in pegfilgrastim alone to 68% in the combination is predicted to result in a statistically significant and clinically meaningful reduction (approximately 50% reduction) in key clinically relevant CIN outcomes including mean DSN, FN rate, mean ANC nadir, hospitalization rate and infection rate (all p