BeyondSpring Announces New DUBLIN-3 Study Analysis Showing Plinabulin Significantly Improves Survival in NSCLC Patients

BeyondSpring announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type non-squamous non-small cell lung cancer, or NSCLC, who progressed after anti-PD-(L) immunotherapy. More than 60% of NSCLC patients eventually develop resistance to anti-PD-(L)1 therapy, yet no new treatments have been approved in a decade. Plinabulin is a late-stage therapeutic candidate that has demonstrated consistent survival benefit in this rapidly growing population with major unmet medical need. In a subset analysis of DUBLIN-3, non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1 therapy with at least 3 months of prior clinical benefit, Plinabulin + docetaxel, or DP, combination showed clinically meaningful improvement compared to docetaxel alone. Median overall survival: DP 15.8 months vs. D 11.7 months; median progression-free survival: DP 5.6 vs. D 3.8 months; objective response rate: 18.2% vs. 8.0%. BeyondSpring plans to initiate a global Phase 3 DUBLIN-4 trial following its End-of-Phase 2 meeting with the U.S. FDA. DUBLIN-4, together with DUBLIN-3, is expected to support a future NDA submission in non-squamous EGFR wild-type NSCLC following progression on anti-PD-(L)1 therapy. Plinabulin significantly reduced docetaxel-induced grade 4 neutropenia. Plinabulin combination had significantly decreased exposure-adjusted grade 3/4 adverse events vs. docetaxel, supporting prolonged treatment exposure and contributing to improved clinical outcomes.