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

BeyondSpring (NASDAQ: BYSI) reported results from the Asian subset (n=488) of the global Phase 3 DUBLIN-3 trial evaluating plinabulin + docetaxel versus docetaxel in 2L/3L EGFR wild-type NSCLC presented at ESMO Asia 2025.

Rhea-AI Summary

BeyondSpring (NASDAQ: BYSI) reported results from the Asian subset (n=488) of the global Phase 3 DUBLIN-3 trial evaluating plinabulin + docetaxel versus docetaxel in 2L/3L EGFR wild-type NSCLC presented at ESMO Asia 2025. In the Asian ITT cohort, combination therapy achieved median OS 10.8 vs 8.8 months (HR 0.81, p=0.0426). In the mechanism‑aligned non‑squamous subgroup the HR was 0.69 with a 3‑month median OS benefit (p=0.0064). The combo doubled 2‑ and 3‑year survival rates and markedly reduced docetaxel‑induced grade 4 neutropenia (DP 3.9% vs D 26.5%, p<0.0001), while maintaining favorable tolerability.

Positive

• Asian ITT OS improvement: 10.8 vs 8.8 months (HR 0.81, p=0.0426)
• Non‑squamous OS HR 0.69 with a 3‑month median benefit (p=0.0064)
• Grade 4 neutropenia reduced: 3.9% (DP) vs 26.5% (D), p<0.0001
• Durable survival: doubled 2‑ and 3‑year survival rates

Negative

• Subset data limited to Asian cohort (n=488), not the full global population
• Modest ITT effect size in Asian cohort (HR 0.81) despite statistical significance (p=0.0426)

Argus Dec 12 session

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Details

News Market Reaction – BYSI

In the Dec 12 session, BYSI declined 3.21%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights late-stage Phase 3 DUBLIN-3 data showing improved overall survival and ...

Analysis

This announcement highlights late-stage Phase 3 DUBLIN-3 data showing improved overall survival and reduced grade 4 neutropenia for Plinabulin plus docetaxel in EGFR wild-type NSCLC, including a non-squamous subgroup with an HR of 0.69. It builds on prior Med and ASCO results positioning Plinabulin as an immune-modulating backbone therapy. Investors may track upcoming global confirmatory studies, financing developments, and any regulatory interactions alongside the company’s lean R&D spend and recent equity raise.

Key Figures

Asian subset size: n=488 patients Treatment arm size: n=243 Control arm size: n=245 +5 more

Asian subset size

n=488 patients

Phase 3 DUBLIN-3 Asian intent-to-treat cohort

Treatment arm size

n=243

Plinabulin + docetaxel (DP) arm in Asian subset

Control arm size

n=245

Docetaxel (D) monotherapy arm in Asian subset

Median OS benefit

10.8 vs 8.8 months

DP vs D overall survival in Asian cohort, HR 0.81, p=0.0426

Non-squamous HR

HR 0.69

Mechanism-based non-squamous subgroup, p=0.0064

Non-squamous OS gain

3-month median OS benefit

Plinabulin + docetaxel vs docetaxel in non-squamous subgroup

Grade 4 neutropenia

3.9% vs 26.5%

DP vs D, p<0.0001, docetaxel-induced neutropenia

Pre-news move

7.92%

24h price change before this Dec 12, 2025 announcement

Historical Context

3 past events · Latest: Nov 12

3 events

1. Nov 12

   Earnings and update

   24h Move

   -3.6%

   Q3 2025 results plus NSCLC and SEED program updates.

2. Aug 13

   Earnings and update

   24h Move

   -0.5%

   Q2 2025 financials and promising NSCLC combination data.

3. Jul 07

   Clinical trial data

   24h Move

   +1.8%

   Med publication showing Plinabulin-driven responses after ICI failure.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 3, overall survival, hazard ratio, p-value, +4 more

8 terms

phase 3 medical

"global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

overall survival medical

"achieved a statistically significant improvement in overall survival compared"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

hazard ratio medical

"HR 0.81, p=0.0426. In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

p-value medical

"HR 0.81, p=0.0426 ... median OS benefit of 3 months (p=0.0064)"

A p-value is a number that helps determine how likely it is that a result or pattern happened by chance rather than because of a real effect. For investors, a low p-value suggests that the findings in a study or analysis are probably meaningful and not just random noise—like noticing a pattern in coin flips that’s unlikely to occur by chance. This helps in assessing the reliability of information used to make financial decisions.

non-small cell lung cancer medical

"second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC)"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

grade 4 neutropenia medical

"marked reduction in docetaxel-induced grade 4 neutropenia (DP: 3.9% vs. D 26.5%"

A severe drop in the number of neutrophils, the white blood cells that act as the body’s first responders to infection; grade 4 means these infection-fighting cells are critically low. For investors, it matters because this level of toxicity can lead to hospital treatment, trial holds, changes in dosing or safety warnings, and therefore can delay approvals or reduce the commercial potential of a drug — like pulling most of the security guards off duty during a crisis.

intent-to-treat medical

"Dublin-3’s global intent-to-treat (ITT) patient data was published"

A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed instructions. Like grading a class by the seats students were assigned rather than who finished the exam, it preserves the trial’s original comparisons and gives a realistic, often more conservative, estimate of how a drug or device performs in real-world use — information investors use to judge reliability and regulatory risk.

dendritic-cell maturation medical

"consistent with Plinabulin’s first-in-class dendritic-cell maturation mechanism"

Dendritic-cell maturation is the process by which immature immune cells develop the ability to recognize and display pieces of pathogens or tumor cells to other immune cells, effectively 'teaching' the body what to attack. For investors, this matters because successful maturation is a key sign that vaccines or immunotherapies can trigger a strong, targeted immune response, affecting clinical trial results, regulatory approval prospects, and commercial potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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/m²) on Day 1 and either plinabulin (30 mg/m²) 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

What were the overall survival results for BYSI plinabulin+docetaxel in the Asian DUBLIN‑3 subset?

In the Asian ITT cohort (n=488) median OS was 10.8 months for plinabulin+docetaxel vs 8.8 months for docetaxel alone (HR 0.81, p=0.0426).

How did plinabulin perform in the non‑squamous EGFR WT subgroup in DUBLIN‑3 Asian patients?

The mechanism‑aligned non‑squamous subgroup showed HR 0.69 with a 3‑month median OS benefit (p=0.0064).

What safety benefits did BYSI report for plinabulin+docetaxel in the Asian subset?

Plinabulin+docetaxel markedly reduced docetaxel‑induced grade 4 neutropenia to 3.9% vs 26.5% (p<0.0001) while maintaining tolerability.

Does the Asian DUBLIN‑3 data support a global registration path for BYSI plinabulin?

Company commentary indicates these Asian results strengthen the case for a global registration path, citing consistent survival and safety benefits.

How large was the Asian DUBLIN‑3 cohort presented at ESMO Asia 2025 for BYSI?

The Asian subset comprised 488 patients (plinabulin+docetaxel n=243; docetaxel n=245).

Where and when were the BYSI Asian DUBLIN‑3 results presented?

Results were presented at ESMO Asia Congress 2025 by Dr. Baohui Han of Shanghai Chest Hospital on December 12, 2025.