BYSI News & Events

BeyondSpring announced results from the Asian subset 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. Dublin-3's global intent-to-treat 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 Asia Congress 2025. In this large Asian intent-to-treat cohort, Plinabulin + docetaxel achieved a statistically significant improvement in overall survival compared to docetaxel: 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, 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, 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, CEO. "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."

BeyondSpring announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type non-squamous non-small cell lung cancer, or NSCLC, who progressed after anti-PD-(L) immunotherapy. 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. 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 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, or DP, combination showed clinically meaningful improvement compared to docetaxel alone. Median overall survival: DP 15.8 months vs. D 11.7 months; median progression-free survival: DP 5.6 vs. D 3.8 months; objective response rate: 18.2% vs. 8.0%. 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. Plinabulin significantly reduced docetaxel-induced grade 4 neutropenia. Plinabulin combination had significantly decreased exposure-adjusted grade 3/4 adverse events vs. docetaxel, supporting prolonged treatment exposure and contributing to improved clinical outcomes.

"With over 700 patients treated, Plinabulin continues to demonstrate a favorable safety profile and meaningful potential as an immune-modulating therapy with unique mechanism of dendritic cell (DC) maturation and T cell priming," said Dr. Lan Huang, Co-Founder, Chair and Chief Executive Officer of BeyondSpring. "With DC bridging innate and adaptive immunity, Plinabulin offers new hope for patients with NSCLC and other cancers whose disease progresses after checkpoint inhibitors, presented at recent SITC conference. In addition, results from our global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, showed that Plinabulin in combination with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia, reinforcing its potential to advance the standard of care and drive long-term value creation."

"At the heart of BeyondSpring's pipeline is Plinabulin, a first-in-class agent potentially redefining cancer treatment by harnessing the body's own immune system," said Dr. Lan Huang, Co-Founder, Chair, and CEO. "Plinabulin's ability to mature dendritic cells in human studies, bridges innate and adaptive immunity, offering potentially new hope to the 60% of NSCLC patients whose disease progresses after checkpoint inhibitor therapy. In our global Phase 3 trial, plinabulin and docetaxel combination compared to standard of care docetaxel alone, delivered durable survival benefits alongside reduced chemotherapy-induced neutropenia - a combination with strong potential to influence standards of care."