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
MWN-AI** Summary
BeyondSpring Inc. (NASDAQ: BYSI) announced promising results from post-hoc analyses of its DUBLIN-3 Phase 3 study for Plinabulin combined with docetaxel in treating non-squamous EGFR wild-type non-small cell lung cancer (NSCLC) patients who progressed after anti-PD-(L)1 therapy. The findings, presented by Dr. Trevor Feinstein at the 2025 IASLC/ASCO North America Conference on Lung Cancer, revealed significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to docetaxel alone.
Specifically, the combination of Plinabulin and docetaxel resulted in a median OS of 15.8 months versus 11.7 months for docetaxel alone, and a median PFS of 5.6 months compared to 3.8 months. Additionally, the ORR was reported at 18.2% with the combination therapy compared to only 8% with docetaxel. Importantly, Plinabulin also showed a reduction in new brain metastases and improved metastasis-free survival, highlighting its unique mechanism that enhances immune function by restoring T-cell activity after patients develop resistance to checkpoint inhibitors.
BeyondSpring plans to initiate a global, double-blind Phase 3 trial, DUBLIN-4, to further validate these findings and support future regulatory submissions. The company emphasized the significance of these results, noting that existing treatment options for patients who experience relapse after anti-PD-(L)1 therapy have remained largely unchanged for the past decade, with docetaxel as the primary option.
Dr. Lan Huang, co-founder and CEO of BeyondSpring, remarked that the data from DUBLIN-3 align with findings from prior studies, reinforcing Plinabulin’s potential to address a critical unmet need in the NSCLC patient population. As a first-in-class agent, Plinabulin’s ability to enhance anti-tumor immune response positions it as a promising therapeutic option moving forward.
MWN-AI** Analysis
BeyondSpring Inc. (NASDAQ: BYSI) has reported compelling new analyses from its DUBLIN-3 study, reinforcing plinabulin's status as a potential late-stage therapy for patients with EGFR wild-type, non-squamous non-small cell lung cancer (NSCLC) who have progressed after anti-PD-(L)1 therapy. The data presents not only a significant improvement in overall survival (OS) and progression-free survival (PFS) but also highlights the drug's role in reducing brain metastases—a critical concern within this patient population.
With OS extending from 11.7 months with docetaxel alone to 15.8 months with the plinabulin-docetaxel combination, and PFS moving from 3.8 to 5.6 months, the clinical implications are substantial. Furthermore, the notable decrease in new brain metastases (4.32% vs. 7.83%) emphasizes plinabulin's unique capabilities as a brain-penetrant agent.
For investors, this data bodes well given the therapeutic area's significant unmet needs; with over 60% of NSCLC patients developing resistance to current treatments and the barren pipeline over the last decade, plinabulin could capture considerable market share. The DUBLIN-4 trial's initiation, aimed at confirming these findings, should be closely monitored as a precursor to an NDA submission.
Currently, BeyondSpring's stock performance reflects a positive market sentiment. With a solid clinical foundation and growing data to support its therapeutic use, investing in BeyondSpring at this stage may present an attractive opportunity. Potential investors should consider not just the immediate data but the forthcoming trial results that could bolster confidence in plinabulin's positioning within the oncology market. As this narrative evolves, the stock may attract increased interest from both institutional and retail investors.
In summary, BeyondSpring stands at a pivotal juncture, with promising data that sets the stage for future growth and potential regulatory success, making it a compelling watch in the biotech sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- In DUBLIN-3 non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1, Plinabulin + docetaxel showed consistent and clinically meaningful improvements in OS, PFS, and ORR, reinforcing Plinabulin as a late-stage therapy with consistent survival benefit in anti-PD-(L)1-progressed NSCLC patients.
- Supported by anti-cancer efficacy and safety in significant reduction exposure-adjusted grade 3/4 adverse events in DUBLIN-3, BeyondSpring will conduct DUBLIN-4, a global, double-blind Phase 3 registrational trial. This study will evaluate Plinabulin + docetaxel vs. docetaxel in non-squamous EGFR wild-type NSCLC after progression on anti-PD-(L)1 and chemotherapy , and is intended to serve as the global confirmatory study.
FLORHAM PARK, N.J., Dec. 11, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study (Lancet Resp Med 12:775, 2024), showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type (WT) non-squamous (NSQ) non-small cell lung cancer (NSCLC) who progressed after anti-PD-(L)1 immunotherapy . The findings were presented by Dr. Trevor Feinstein of Piedmont Cancer Center and acting chair of the Lung Disease Group for the OneOncology network at the 2025 IASLC/ASCO North America Conference on Lung Cancer (NACLC) .
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. Nine late-stage trials , including ADC and anti-PD-(L)1combination regimens, have failed to show overall survival improvement over docetaxel . 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 mechanism-driven, post-hoc 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 (DP) combination showed clinically meaningful improvement compared to docetaxel alone (D).
- Median overall survival (OS): DP 15.8 months vs. D 11.7 months (HR=0.55),
- Median progression-free survival (PFS): DP 5.6 vs. D 3.8 months (HR=0.67),
- Objective response rate (ORR): 18.2% vs. 8.0% .
These benefits reflect Plinabulin ’s first-in-class dendritic-cell maturation mechanism, which helps to restore antigen presentation and T-cell function after acquired resistance to checkpoint inhibitors .
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.
Post-hoc analysis of DUBLIN-3 intent-to-treat (ITT, N=559) EGFR WT NSCLC population showed additional clinically meaningful benefits for the Plinabulin + docetaxel combination compared to docetaxel.
- Meaningful improvement in metastasis-free survival : Metastasis-free survival improved to 15.34 months (DP) versus 7.7 months (D, HR=0.52, p=0.0012), consistent with Plinabulin’s DC maturation and durable anti-cancer benefit.
- Reduction in new brain metastasis: The incidence of new brain metastasis was reduced to 4.32% (DP) vs. 7.83% (D), consistent with Plinabulin’s brain-penetrant properties which demonstrated survival benefit in glioblastoma anal model as a monotherapy.
- Improved safety: Plinabulin significantly reduced docetaxel-induced grade 4 neutropenia (5.13% vs. 33.58%, p<0.0001). Plinabulin combination had significantly decreased exposure-adjusted grade 3/4 adverse events vs. docetaxel (p=0.0235), supporting prolonged treatment exposure and contributing to improved clinical outcomes.
“Patients who relapse after anti-PD-(L)1 therapy represent one of the most significant unmet needs in NSCLC, with docetaxel as the only treatment option while multiple late-stage clinical trials have failed to improve upon it,” said Dr. Trevor Feinstein .
Dr. Lan Huang , Co-Founder, Chairman, and CEO of BeyondSpring, said, “These new analyses suggest Plinabulin’s unique ability to potentially reinvigorate anti-tumor immune function and improve outcomes in patients who have developed resistance to checkpoint inhibitors. The post-hoc analysis data from DUBLIN-3 are consistent with our findings from the prospective 303 study in similar patients, as presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting. The observed reductions in brain metastasis and the substantial improvement in metastasis-free survival further highlight Plinabulin’s differentiated clinical profile. These findings provide strong momentum as we move forward with our global confirmatory Phase 3 DUBLIN-4 trial .”
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
FAQ**
How does BeyondSpring Inc. BYSI plan to leverage the DUBLIN-4 trial results to further validate Plinabulin's efficacy in patients who have progressed after anti-PD-(L)1 therapy?
What specific patient demographics will BeyondSpring Inc. BYSI target in the upcoming DUBLIN-4 trial, and how do they align with the findings from DUBLIN-3?
In light of the DUBLIN-3 results, how does BeyondSpring Inc. BYSI's Plinabulin + docetaxel combination compare to existing treatments for NSCLC in terms of safety and efficacy?
Given the significant unmet need in NSCLC post-PD-(L)1 therapy, how does BeyondSpring Inc. BYSI plan to communicate the benefits of Plinabulin to both patients and healthcare providers?
**MWN-AI FAQ is based on asking OpenAI questions about BeyondSpring Inc. (NASDAQ: BYSI).
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