BeyondSpring(BYSI) GlobeNewswire News Room·2024-09-16 11:00Core Insights - BeyondSpring Inc. presented interim phase 2 data on the 303 Study for 2L/3L non-small cell lung cancer (NSCLC) at the ESMO Congress 2024, highlighting the efficacy of a triple combination therapy involving pembrolizumab, plinabulin, and docetaxel [1][3][6] Company Overview - BeyondSpring is a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, with its lead asset, Plinabulin, in late-stage clinical development for NSCLC and other cancer indications [10] Study Details - The 303 Study is a single-arm, open-label phase 2 trial evaluating the efficacy and safety of a combination regimen of pembrolizumab, plinabulin, and docetaxel in patients with metastatic NSCLC who have progressed after prior treatment with immune checkpoint inhibitors [3][9] - The study aims to enroll a total of 47 patients, with a formal interim analysis conducted on 19 evaluable patients [3][9] Efficacy Results - The confirmed overall response rate (ORR) for the combination therapy was reported at 21.1%, with a median progression-free survival (PFS) of 8.63 months [5] - The disease control rate (DCR) was notably high at 89.5%, indicating a significant clinical benefit for patients with severe unmet medical needs [5][6] - The median duration of response (DoR) was reported at 11.40 months, with a 6-month PFS rate of 67.1% and a 12-month PFS rate of 49.2% [5][6] Safety Profile - The combination therapy was well tolerated, with 52.6% of patients experiencing grade 3 or higher treatment-related adverse effects, and no treatment-related deaths reported [5][6] Mechanism of Action - Plinabulin acts as a potent inducer of dendritic cell maturation, enhancing T cell activation and potentially overcoming resistance to immune checkpoint inhibitors [6][8]