Core Insights - BeyondSpring Inc. announced significant findings from the Asian subset of its Phase 3 DUBLIN-3 trial, demonstrating that Plinabulin combined with docetaxel improves overall survival in patients with EGFR wild-type non-small cell lung cancer (NSCLC) [1][4] Group 1: Clinical Trial Results - In the Asian intent-to-treat cohort, the combination of Plinabulin and docetaxel (DP) achieved a median overall survival of 10.8 months compared to 8.8 months for docetaxel alone (D), with a hazard ratio of 0.81 and a p-value of 0.0426 [2] - The mechanism-based non-squamous subgroup showed a hazard ratio of 0.69 with a median overall survival benefit of 3 months (p=0.0064), indicating enhanced efficacy in patients aligned with Plinabulin's immune-modulating mechanisms [8] Group 2: Safety and Tolerability - Plinabulin significantly reduced the incidence of docetaxel-induced grade 4 neutropenia (3.9% for DP vs. 26.5% for D, p<0.0001), while maintaining a favorable tolerability profile, which is crucial for chemotherapy benefit [3] - The safety improvements support better treatment exposure, which is an important factor in the effectiveness of chemotherapy [3] Group 3: Company Overview and Future Directions - BeyondSpring is focused on developing first-in-class therapies for high unmet medical needs, with Plinabulin as its lead asset in late-stage clinical development for NSCLC and other indications [7] - The company plans to advance Plinabulin into a global Phase 3 confirmatory study, bolstered by the robust evidence from the DUBLIN-3 trial [5]

Core Insights - BeyondSpring Inc. announced new post-hoc analyses from its Phase 3 DUBLIN-3 Study, indicating that Plinabulin combined with docetaxel offers significant clinical benefits for patients with EGFR wild-type non-squamous non-small cell lung cancer who have progressed after anti-PD-(L)1 therapy [1][6] Company Overview - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to address high unmet medical needs, with its lead asset, Plinabulin, in late-stage clinical development for non-small cell lung cancer and other indications [12] Study Findings - The DUBLIN-3 Study involved 559 patients with EGFR wild-type NSCLC who progressed after first-line platinum-based therapy, showing that the combination of Plinabulin and docetaxel resulted in improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to docetaxel alone [11][7] - Median OS for the Plinabulin + docetaxel group was 15.8 months compared to 11.7 months for docetaxel alone, with a hazard ratio (HR) of 0.55 [7] - Median PFS was 5.6 months for the combination therapy versus 3.8 months for docetaxel alone, with an HR of 0.67 [7] - The ORR was 18.2% for the combination compared to 8.0% for docetaxel alone [7] Mechanism of Action - Plinabulin operates through a unique dendritic-cell maturation mechanism, which aids in restoring antigen presentation and T-cell function after resistance to checkpoint inhibitors [4][10] Future Plans - BeyondSpring plans to initiate a global Phase 3 DUBLIN-4 trial to further evaluate the Plinabulin + docetaxel combination in patients with non-squamous EGFR wild-type NSCLC after progression on anti-PD-(L)1 therapy [4][6] Safety Profile - The combination therapy significantly reduced the incidence of grade 4 neutropenia (5.13% vs. 33.58%, p<0.0001) and showed a decrease in exposure-adjusted grade 3/4 adverse events compared to docetaxel alone, supporting prolonged treatment exposure and improved clinical outcomes [8][6]

Core Insights - BeyondSpring Inc. presented interim Phase 2 data for its 303 Study on Plinabulin in combination with pembrolizumab and docetaxel for metastatic non-small cell lung cancer (NSCLC) patients who progressed on PD-1/L1 therapies, showing promising results in terms of progression-free survival and overall survival [1][2][3] Study Overview - The 303 Study enrolled 47 patients, with a median age of 67, and included a majority of male patients (80.9%) and current or former smokers (72.3%) [2] - The study evaluated the efficacy and safety of the triple combination therapy, with a median follow-up of 12.7 months [2][10] Key Results - Median Progression-Free Survival (PFS) was reported at 6.8 months, nearly double the 3.7 months seen with standard of care docetaxel [6] - Disease Control Rate (DCR) was 77.3%, indicating a clinical benefit for the majority of patients who had previously progressed on PD-1/L1 inhibitors [6] - The 15-month Overall Survival (OS) rate was 78%, which is longer than the median OS of 11.8 months for standard of care docetaxel [6] Mechanism of Action - Plinabulin is a first-in-class, late-stage differentiated tubulin binder that activates GEF-H1, leading to dendritic cell maturation and T cell activation, which may reverse acquired resistance to immune checkpoint inhibitors [5][9] Clinical Implications - The results suggest that Plinabulin could address the significant unmet medical need for effective treatments in NSCLC patients who have developed resistance to PD-1/L1 therapies [4][7] - The combination therapy demonstrated good tolerability, with 51.1% of patients experiencing grade 3 or higher treatment-related adverse effects, but no treatment-related deaths were reported [6]

Company Overview - BeyondSpring Inc. is a clinical-stage global biopharmaceutical company focused on developing cancer therapies, particularly its lead asset Plinabulin, which is in late-stage clinical development for non-small cell lung cancer (NSCLC) and other cancer indications [3] Study Announcement - BeyondSpring announced a poster presentation on the 303 Study, an investigator-initiated study supported by Merck, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3 in Chicago, IL [1] 303 Study Details - The 303 Study is an open-label, single-arm Phase 2 study evaluating the efficacy and safety of Plinabulin in combination with docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC who have progressed after anti-PD-(L)1 inhibitor therapy [4] - The study involves 47 enrolled patients and is conducted at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang as the principal investigator [4] - The primary endpoint is the investigator-based overall response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety [4] Presentation Details - The presentation will take place on May 31, 2025, from 1:30 PM to 4:30 PM CDT at McCormick Place Convention Center, focusing on initial efficacy and safety results related to immune re-sensitization [5]