BeyondSpring Announces New Analyses of DUBLIN-3 Phase 3 Study Showing Survival Benefit of Plinabulin + Docetaxel in Post Anti-PD-(L)1 for Non-squamous EGFR WT NSCLC and a Reduction in Brain Metastasis Compared to Docetaxel at NACLC 2025

Core Insights - BeyondSpring Inc. announced new post-hoc analyses from its Phase 3 DUBLIN-3 Study, indicating that Plinabulin combined with docetaxel offers significant clinical benefits for patients with EGFR wild-type non-squamous non-small cell lung cancer who have progressed after anti-PD-(L)1 therapy [1][6] Company Overview - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to address high unmet medical needs, with its lead asset, Plinabulin, in late-stage clinical development for non-small cell lung cancer and other indications [12] Study Findings - The DUBLIN-3 Study involved 559 patients with EGFR wild-type NSCLC who progressed after first-line platinum-based therapy, showing that the combination of Plinabulin and docetaxel resulted in improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to docetaxel alone [11][7] - Median OS for the Plinabulin + docetaxel group was 15.8 months compared to 11.7 months for docetaxel alone, with a hazard ratio (HR) of 0.55 [7] - Median PFS was 5.6 months for the combination therapy versus 3.8 months for docetaxel alone, with an HR of 0.67 [7] - The ORR was 18.2% for the combination compared to 8.0% for docetaxel alone [7] Mechanism of Action - Plinabulin operates through a unique dendritic-cell maturation mechanism, which aids in restoring antigen presentation and T-cell function after resistance to checkpoint inhibitors [4][10] Future Plans - BeyondSpring plans to initiate a global Phase 3 DUBLIN-4 trial to further evaluate the Plinabulin + docetaxel combination in patients with non-squamous EGFR wild-type NSCLC after progression on anti-PD-(L)1 therapy [4][6] Safety Profile - The combination therapy significantly reduced the incidence of grade 4 neutropenia (5.13% vs. 33.58%, p<0.0001) and showed a decrease in exposure-adjusted grade 3/4 adverse events compared to docetaxel alone, supporting prolonged treatment exposure and improved clinical outcomes [8][6]