# BeyondSpring Announces ESMO Asia Presentation on Plinabulin + Docetaxel Improving Survival in Large Phase 3 DUBLIN-3 Asian Subset for EGFR WT NSCLC Compared to Docetaxel, Strengthening the Case for a Global Registration Path Canonical URL: https://biopharmsignal.com/news/BYSI/beyondspring-announces-esmo-asia-presentation-on-plinabulin-docetaxel-improving--bb928d08 Ticker: BYSI Company: BeyondSpring, Inc. Source: BeyondSpring, Inc. Published: 2025-12-12 12:00 EST ## Summary Consistent OS benefit in an Asian subset with a strong HR of 0.69 for non-squamous patients, and meaningful safety advantage position Plinabulin as a... ## Article Body Consistent OS benefit in an Asian subset with a strong HR of 0.69 for non-squamous patients, and meaningful safety advantage position Plinabulin as a late-stage candidate showing survival improvement in 2L/3L EGFR WT NSCLC. FLORHAM PARK, N.J., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced results from the Asian subset (n=488) of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC). Dublin-3’s global intent-to-treat (ITT) patient data was published in Lancet Respiratory Medicine in 2024. These new findings were presented by Dr. Baohui Han of Shanghai Chest Hospital at the European Society for Medical Oncology (ESMO) Asia Congress 2025 . In this large Asian intent-to-treat cohort, Plinabulin + docetaxel (DP, n=243) achieved a statistically significant improvement in overall survival compared to docetaxel (D, n=245): DP 10.8 months vs. D 8.8 months, HR 0.81, p=0.0426. In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69 with a median OS benefit of 3 months (p=0.0064) , highlighting enhanced benefit in patients whose disease biology aligns with Plinabulin’s immune-modulating and tumor vasculature-targeting mechanisms. The combination also doubled 2-year and 3-year survival rates , reflecting durable benefit consistent with Plinabulin’s first-in-class dendritic-cell maturation mechanism . Plinabulin demonstrated a marked reduction in docetaxel-induced grade 4 neutropenia (DP: 3.9% vs. D 26.5%, p<0.0001), while maintaining a favorable tolerability profile. This safety improvement supports better treatment exposure, an important driver of chemotherapy benefit . “These data from nearly 500 Asian patients further strengthen the robust global evidence supporting Plinabulin’s potential to become a new standard of care for EGFR wild-type NSCLC, ” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring. “The consistent survival benefit, particularly in the mechanism-aligned non-squamous population, together with the marked reduction in severe neutropenia, reflects Plinabulin’s first-in-class immune-modulating mechanism and its ability to improve chemotherapy tolerability . These results reinforce our confidence as we advance Plinabulin into a global Phase 3 confirmatory study .” About Plinabulin Plinabulin is a first-in-class, brain-penetrating, dendritic-cell maturation small molecule. It has been used in over 700 cancer patients, with good tolerability and showed durable anti-cancer benefit across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. In addition, plinabulin significantly reduces chemotherapy-induced neutropenia and could thereby increase docetaxel tolerability. About DUBLIN-3 Study (103 Study) DUBLIN-3 (n=559, NCT02504489) was a multicenter, single-blinded (patient) and randomized, phase 3 trial in 58 medical centers (US, China, and Australia). Only patients with EGFR wild-type NSCLC who had progressed after first-line platinum-based therapy were enrolled. Patients were randomized (1:1) to receive docetaxel (75 mg/m 2 ) on Day 1 and either plinabulin (30 mg/m 2 ) or placebo on Days 1 and 8 in 21-day cycles until progression, unacceptable toxicity, withdrawal, or death. Treated patients were included in the safety analysis and ITT population in the primary efficacy analyses. The primary endpoint for the study was OS, and secondary endpoints were PFS, ORR, Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. The study was published in Lancet Resp Med 12:775, 2024. About BeyondSpring BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin’s novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at https://beyondspringpharma.com . Investor Contact: IR@beyondspringpharma.com Media Contact: PR@beyondspringpharma.com ## Recent Company News - 2026-06-04 11:00 EST — [BeyondSpring Announces Leadership Transition to Deliver Focused Execution on Its Confirmatory DUBLIN-4 Program and Long-Term Value](https://biopharmsignal.com/news/BYSI/beyondspring-announces-leadership-transition-to-deliver-focused-execution-on-its-7cdf7bc8) — Source: BeyondSpring, Inc. - 2026-06-02 11:00 EST — [BeyondSpring Presents the Latest Update of a Phase 2 Study Demonstrating Durable Clinical Benefit of Pembrolizumab Plus Plinabulin/Docetaxel in Metastatic NSCLC After Progression on First-Line Immune Checkpoint Inhibitor Therapy at ASCO 2026](https://biopharmsignal.com/news/BYSI/beyondspring-presents-the-latest-update-of-a-phase-2-study-demonstrating-durable-b6c4b5ec) — Source: BeyondSpring, Inc. - 2026-05-18 11:00 EST — [BeyondSpring Announces Poster Presentation at 2026 ASCO Annual Meeting](https://biopharmsignal.com/news/BYSI/beyondspring-announces-poster-presentation-at-2026-asco-annual-meeting-121bfb8e) — Source: BeyondSpring, Inc. - 2026-05-13 11:00 EST — [BeyondSpring Reports First-Quarter 2026 Financial Results and Provides Corporate Update](https://biopharmsignal.com/news/BYSI/beyondspring-reports-first-quarter-2026-financial-results-and-provides-corporate-7bef7d23) — Source: BeyondSpring, Inc. - 2026-04-22 11:00 EST — [BeyondSpring Reports Compelling New Data: Plinabulin Advances Both the Anticancer Efficacy and Safety of ADC Drugs](https://biopharmsignal.com/news/BYSI/beyondspring-reports-compelling-new-data-plinabulin-advances-both-the-anticancer-ba2782eb) — Source: BeyondSpring, Inc. ## Related News - 2026-07-29 14:05 EST — CAPR — [The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy](https://biopharmsignal.com/news/CAPR/the-lancet-publishes-hope-3-data-for-capricor-therapeutics-deramiocel-in-duchenn-9e6e6bd9) - 2026-07-29 13:00 EST — ENLV — [Enlivex Management to Host Webinar to Discuss Capital Strategy, Rain Protocol Treasury Strategy, and Recent Clinical Milestones](https://biopharmsignal.com/news/ENLV/enlivex-management-to-host-webinar-to-discuss-capital-strategy-rain-protocol-tre-5921a627) - 2026-07-29 12:30 EST — PRGO — [Perrigo to Present at the Canaccord 46th Annual Growth Conference](https://biopharmsignal.com/news/PRGO/perrigo-to-present-at-the-canaccord-46th-annual-growth-conference-40431922) - 2026-07-29 12:30 EST — LIXT — [NOMAD Announces Operational Deployment of Two Mobile Battery Systems by DSO Electric Cooperative](https://biopharmsignal.com/news/LIXT/nomad-announces-operational-deployment-of-two-mobile-battery-systems-by-dso-elec-7fc12a2c) - 2026-07-29 12:30 EST — RNXT — [RenovoRx to Host Second Quarter 2026 Financial Results and Business Highlights Conference Call on August 12th at 4:30 p.m. ET](https://biopharmsignal.com/news/RNXT/renovorx-to-host-second-quarter-2026-financial-results-and-business-highlights-c-8bed10ec)