BeyondSpring to Present 303 Study Findings at 2025 ASCO Annual Meeting

BeyondSpring to present findings from the 303 Study at the 2025 ASCO Annual Meeting, evaluating efficacy and safety of a combination therapy in NSCLC patients. The presentation will showcase results from a Phase 2 trial investigating Pembrolizumab, Plinabulin, and Docetaxel in previously treated patients. Conducted at Peking Union Medical College Hospital in Beijing, the study aims to address unmet medical needs in cancer treatment.

BeyondSpring Inc. (NASDAQ: BYSI) will present findings from its 303 Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3 in Chicago. The presentation, titled "Phase 2 Study of Pembrolizumab plus Plinabulin and Docetaxel for Patients with Metastatic NSCLC," will be delivered on May 31, 2025, from 1:30 PM to 4:30 PM CDT at the McCormick Place Convention Center [1].

The 303 Study is an open-label, single-arm Phase 2 trial investigating the combination of Pembrolizumab, Plinabulin, and Docetaxel in previously treated patients with metastatic Non-Small Cell Lung Cancer (NSCLC) who progressed on PD-1/PD-L1 inhibitors. The study, conducted at Peking Union Medical College Hospital in Beijing, aims to address unmet medical needs in cancer treatment by evaluating the efficacy and safety of this triple combination therapy [1].

The primary endpoint of the study is investigator-based objective response rate (ORR) using RECIST 1.1 criteria. Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety. The regimen includes Pembrolizumab 200 mg IV every 3 weeks (Q3W) on Day 1, Docetaxel 75 mg/m2 IV Q3W on Day 1, and Plinabulin 30mg/m2 IV Q3W on Day 1 in a 21-day cycle [1].

BeyondSpring's lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and a range of cancer indications. Its novel mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors to checkpoint inhibitors [1].

The presentation will provide insights into the initial efficacy and safety results related to immune re-sensitization in patients who progressed after first-line immune checkpoint inhibitor therapy. This information could be significant for investors and financial professionals, as it highlights BeyondSpring's progress in developing innovative cancer therapies [1].

References:
[1] https://www.globenewswire.com/news-release/2025/05/28/3089325/0/en/BeyondSpring-Announces-Poster-Presentation-at-2025-ASCO-Annual-Meeting.html
[2] https://www.stocktitan.net/news/BYSI/beyond-spring-announces-poster-presentation-at-2025-asco-annual-ie6odn0k2sby.html