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- Statistically Significant and Clinically Meaningful Efficacy Data with Favorable Benefit/Risk ratio from DUBLIN-3 Phase 3 Study of Plinabulin plus Docetaxel vs. Docetaxel in EGFR Wild-Type NSCLC after Progression on Platinum-based Therapy

- Plinabulin/Docetaxel Combination Significantly Improved Overall Survival (OS), Progression Free Survival (PFS), Objective Response Rate (ORR), 2- and 3-year OS Rates and Significantly Reduced Grade 4 Neutropenia vs. Docetaxel

FLORHAM PARK, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announces Dublin-3 final phase 3 efficacy data of its late clinical-stage agent Plinabulin in combination with docetaxel in second/third line (2L/3L) advanced and metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) wild-type. The lead principal investigator, Dr. Trevor Feinstein from Piedmont Cancer Institute, presented the data in an oral presentation (OA08.04) at ISLAC 2024 World Conference on Lung Cancer on September 9^th 2024 in San Diego, CA. Concurrently, Dublin-3 study was published in the Lancet Respiratory Medicine (https://doi.org/10.1016/S2213-2600(24)00178-4).

Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations despite severe neutropenia (>40%) that greatly impair patients’ quality of life. Six recent phase 3 studies in patients with EGFR wild-type NSCLC who were previously treated with immune checkpoint inhibitors failed to show overall survival (OS) benefit compared with docetaxel (SAPPHIRE, LEAP-008, CONTACT01, EVOKE-01, CARMEN-LC03, and CANOPY-2). Two phase 3 studies (LUNAR and TROPION-Lung01) showed positive but mixed outcomes compared with docetaxel.

The DUBLIN-3 study was a multicenter, randomized, single-blind, placebo-controlled trial that enrolled patients from 58 medical centers internationally. For the intention-to-treat (ITT) population, 559 patients received either docetaxel plus plinabulin (n=278 [male 199, female 79]) or docetaxel plus placebo (n=281 [male 207, female 74]).

Key findings of Dublin-3 study are summarized below:

• Favorable benefit/risk ratio: Significant improvement in OS (Hazard ratio or HR=0.82; same HR in the Western vs. Asian patients), PFS (HR=0.79) and ORR (nearly doubled). Durable anti-cancer benefits in doubling 24-months and 36-months OS rates. And 82% relative reduction in Grade 4 neutropenia in Cycle 1 Day 8 (p<0.0001).

• Consistent OS benefit in 24-month follow up after the database lock: OS HR=0.81 in the ITT population, with better OS benefit in the non-squamous subset (OS HR=0.72, p=0.0078). For the non-squamous subset patients, median OS (mOS) in plinabulin/docetaxel arm was 11.4 months vs. 8.8 months in the docetaxel arm, with a mOS benefit of 2.6 months.

• Improved OS benefit with more cycles of treatment (≥ 4, 6, 8, 10, or 12 cycles): for patients who used at least 4 cycles of treatment, OS HR=0.64, p=0.0027, with a mOS benefit of 4.8 months (plinabulin/docetaxel arm n=133; docetaxel arm n=127).

• Plinabulin/docetaxel combination is well-tolerated: Treatment-emergent adverse-events occurred in 273/274 (99·6%) of patients in the plinabulin group and 276/278 (99·3%) in the control group. Higher incidences of Grade 3/4 gastrointestinal disorders (46 patients [16·8%] vs. 8 [2·9%]) and transient Grade 3 hypertension (50 patients [18·2%] vs. 8 [2·9%]) occurred in the plinabulin vs. control group.