BYSI BeyondSpring Inc

BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announces that it will have an oral presentation on the final efficacy data of Plinabulin and docetaxel combination vs. docetaxel from Dublin-3 phase 3 study in EGFR wild-type 2L/3L non-small cell lung cancer (NSCLC) at the 2024 World Conference on Lung Cancer, on September 9, 2024 in San Diego, CA, and two poster presentations on Dublin-3 study safety outcome and 303 Study, the investigator-initiated study supported by Merck (known as MSD outside of the United States and Canada) in 2L/3L NSCLC who failed PD-1/PD-L1 inhibitors at European Society for Medical Oncology (ESMO) Congress 2024, on September 14, 2024 in Barcelona, Spain.

​​Presentation details are as follows:

2024 World Conference on Lung CancerOral (OA08.04): Plinabulin/Docetaxel vs. Docetaxel in 2L/3L NSCLC after Platinum Regimens (DUBLIN-3): A Phase 3 Randomized Controlled Trial

• Presenter: Dr. Trevor M. Feinstein, Principal investigator for Dublin-3 study, Piedmont Cancer Institute, Atlanta, GA, USA
• Presentation Time: Monday, September 9, 2024, at 10:57AM to 11:07AM PDT
• Session: OA08. The New Generation of Cytotoxics

ESMO Congress 2024Poster (1358P): Plinabulin/Docetaxel Versus Docetaxel in Survival Benefits of 2L/3L EGFR Wild-Type NSCLC after Platinum Regimens (DUBLIN-3): a Randomized Phase 3 Trial

• Presenter: Dr. Trevor M. Feinstein
• Presentation Time: Saturday, September 14, 2024, at 9AM to 6:30PM CEST
• Location: Hall 3, Av. Joan Carles I, 64                  08908 L’hospitalet de Llobregat                  Barcelona, Spain

• Session: NSCLC, metastatic

Poster (1330P): Phase 2 Study of Pembrolizumab (Pemb) plus Plinabulin (Plin) and Docetaxel (Doc) for Patients (pts) with Metastatic NSCLC after Failure on First-line Immune Checkpoint Inhibitor Alone or Combination Therapy: Initial Efficacy and Safety Results on Immune Re-sensitization

• Presenter: Dr. Yan Xu, Investigator, Peking Union Medical College Hospital, Beijing, China
• Presentation Time: Saturday, September 14, 2024, at 9AM to 6:30PM CEST
• Location: Hall 3, Av. Joan Carles I, 64                  08908 L’hospitalet de Llobregat                  Barcelona, Spain

• Session: NSCLC, metastatic

About BeyondSpringBeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, a potent inducer of dendritic cell maturation, in late-stage clinical development as a direct anti-cancer agent in NSCLC and a variety of cancer indications. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring is an equity owner of SEED Therapeutics, Inc which is a pioneer in Target Protein Degradation technology and its application in innovative drug development. Learn more by visiting https://beyondspringpharma.com.

About Dublin-3 StudyDublin-3 NSCLC was a global Phase 3 randomized, controlled clinical trial comparing the combination of Plinabulin and docetaxel to an active control arm of docetaxel alone (1:1 randomization) in second- and third-line NSCLC patients who had failed platinum doublet therapies, and who were Epidermal Growth Factor Receptor (EGFR) wild-type. Docetaxel was given on Day 1 in both arms at 75 mg/m2 in each 21-day cycle. Plinabulin was given on Day 1, one hour after docetaxel, and on Day 8, both at 30 mg/m2 in each cycle. The primary endpoint for the study was overall survival, and secondary endpoints were Progression Free Survival (PFS), Overall Response Rate (ORR), Duration of Response (DoR), Grade 4 neutropenia and Quality of Life.

About 303 StudyStudy 303 is an open-label, single-arm Phase 2 Study of Plinabulin plus docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC and progressive disease after anti-PD-(L)1 inhibitor alone or in combination with platinum-doublet chemotherapy. This study evaluates the efficacy and safety of this triple combination and is being conducted at Peking Union Medical College Hospital, Beijing, China with Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine, as the principal investigator and with Merck. Patients enrolled are receiving the following interventional treatments. The primary endpoint is investigator-based ORR (RECIST 1.1). The secondary endpoints include PFS, OS, DoR, and safety. The study intends to enroll 47 patients with a formal interim analysis of 19 patients enrolled. 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. The study is funded by Merck’s Investigator Studies Program with provision of study drug and financial support.

Investor Contact:IR@beyondspringpharma.com

Media Contact:PR@beyondspringpharma.com