BeyondSpring Announces Oral Presentation at the 2024 World Conference on Lung Cancer and Two Poster Presentations During ESMO Congress 2024 Showcasing its Lead Anti-Cancer Asset, Plinabulin

Rhea-AI Summary

BeyondSpring Inc. (NASDAQ: BYSI) announces upcoming presentations showcasing its lead anti-cancer asset, Plinabulin, at two major oncology conferences. At the 2024 World Conference on Lung Cancer on September 9, an oral presentation will reveal final efficacy data of Plinabulin and docetaxel combination vs. docetaxel from the Dublin-3 phase 3 study in EGFR wild-type 2L/3L non-small cell lung cancer (NSCLC).

Additionally, at the ESMO Congress 2024 on September 14, two poster presentations will cover the Dublin-3 study safety outcome and the 303 Study, an investigator-initiated study supported by Merck in 2L/3L NSCLC patients who failed PD-1/PD-L1 inhibitors. These presentations highlight BeyondSpring's ongoing efforts in developing innovative cancer therapies, particularly for lung cancer patients.

Positive

• Oral presentation of final efficacy data from Dublin-3 phase 3 study at World Conference on Lung Cancer
• Two poster presentations at ESMO Congress 2024 showcasing Plinabulin's potential in NSCLC
• Collaboration with Merck on investigator-initiated study (303 Study)

Negative

• None.

FLORHAM PARK, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- 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 Cancer
Oral (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 2024
Poster (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 BeyondSpring
BeyondSpring 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 Study
Dublin-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 Study
Study 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

FAQ

What is BeyondSpring's lead anti-cancer asset being presented at the 2024 World Conference on Lung Cancer?

BeyondSpring's lead anti-cancer asset being presented is Plinabulin, specifically in combination with docetaxel for EGFR wild-type 2L/3L non-small cell lung cancer (NSCLC).

When and where will BeyondSpring (BYSI) present the final efficacy data of the Dublin-3 phase 3 study?

BeyondSpring will present the final efficacy data of the Dublin-3 phase 3 study at the 2024 World Conference on Lung Cancer on September 9, 2024, in San Diego, CA.

What studies will BeyondSpring (BYSI) present at the ESMO Congress 2024?

At the ESMO Congress 2024, BeyondSpring will present two poster presentations: one on the Dublin-3 study safety outcome and another on the 303 Study, which is an investigator-initiated study supported by Merck for 2L/3L NSCLC patients who failed PD-1/PD-L1 inhibitors.

Who is presenting BeyondSpring's (BYSI) Dublin-3 study results at the 2024 World Conference on Lung Cancer?

Dr. Trevor M. Feinstein, Principal investigator for the Dublin-3 study from Piedmont Cancer Institute in Atlanta, GA, USA, will be presenting the results at the 2024 World Conference on Lung Cancer.