Business
BeyondSpring Pharmaceuticals Announces Positive Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination versus Docetaxel Alone in 2nd/3rd Line Non-Small Cell Lung Cancer Patients with EGFR Wild Type at the European Society for Medical On...
BeyondSpring Pharmaceuticals Announces Positive Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination versus Docetaxel Alone in 2nd/3rd Line
About this update from Beyondspring, Inc.
[{"type":"text","content":"BeyondSpring Pharmaceuticals Announces Positive Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination versus Docetaxel Alone in 2nd/3rd Line Non-Small Cell Lung Cancer Patients with EGFR Wild Type at the European Society for Medical Oncology (ESMO) 2021 Congress \n Study met the primary endpoint showing statistically significant improvement in overall survival (OS) for the combination (DP) vs. docetaxel (D).Study met key secondary endpoints showing statistically significant improvement for DP vs. D in ORR, PFS, and 24- and 36-month OS rates, significant reduction in incidence of Grade 4 neutropenia and clinically meaningful relative improvement in Q-TWiST of 18.4%. In PD-1/PD-L1 exposed patients, DP had longer OS benefit vs. D (HR = 0.68); and the 24 M OS rate in the combination was triple that of docetaxel (p=0.0026). BeyondSpring plans to seek U.S. FDA and China NMPA approval for plinabulin in combination with docetaxel in 2nd/3rd line NSCLC based on the demonstrated clinical benefit and safety profile, with an anticipated NDA filing in 1H 2022.More detailed data will be presented live at 8:10 a.m. ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m. ET today. Dial-in: 877-451-6152, conference ID#: 13723041 NEW YORK, Sept. 20, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today will have a late-breaking oral presentation at the European Society for Medical Oncology 2021 Congress. This includes the final intention-to-treat (ITT) dataset from the Company’s DUBLIN-3 Phase 3 registrational trial of its first-in-class lead asset, plinabulin, in combination with docetaxel vs. docetaxel alone for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) patients with EGFR wild type. Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. The DUBLIN-3 Phase 3 trial is a randomized, active controlled, single blind to patients, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with a measurable lung lesion. Patients were treated on a 21-day cycle with infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on d...