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]