BeyondSpring(BYSI) GlobeNewswire News Room·2024-11-11 13:00Core Insights - BeyondSpring Inc. presented phase 2 IIT data on plinabulin for non-small cell lung cancer (NSCLC) at the SITC Annual Meeting, indicating promising efficacy and safety results [1][7]. Study Overview - The 303 Study is an ongoing phase 2 trial evaluating a combination of pembrolizumab, plinabulin, and docetaxel in patients with metastatic NSCLC who have progressed after PD-1/PD-L1 inhibitors [3][9]. - The study aims to enroll a total of 47 patients, with 30 patients already treated and reported on [4][9]. Patient Demographics - The median age of treated patients was 68 years, with 73.3% male and 60% being current or former smokers [4]. - Histological breakdown showed 57% with non-squamous cell carcinoma and 43% with squamous cell carcinoma [4]. Efficacy Results - The confirmed overall response rate (ORR) for the combination therapy was 21.1% [5]. - The median progression-free survival (PFS) was reported at 8.6 months, which is significantly higher than historical controls [5][6]. - The disease control rate was 89.3%, indicating a strong clinical benefit [5][6]. Safety Profile - The combination therapy was generally well tolerated, with 46.7% of patients experiencing grade 3 or higher treatment-related adverse effects [5]. - The most common adverse effects included myelosuppression and gastrointestinal issues, each at 13.3% [5]. 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]. - This unique mechanism contributes to its differentiated activity and tolerability compared to other treatments [8]. Company Background - BeyondSpring is focused on developing innovative therapies for high unmet medical needs, with plinabulin as its lead asset in late-stage clinical development for NSCLC [10].