- Topline results, released in early August, demonstrated improvement in overall survival (OS) for the combination vs. docetaxel alone as well as improvement in ORR, PFS, 24- and 36-month OS rates and incidence of Grade 4 neutropenia.
NEW YORK, Aug. 31, 2021 (GLOBE NEWSWIRE) — BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced a late-breaking oral presentation at the European Society for Medical Oncology 2021 Congress taking place virtually September 16-21, 2021. This will include the final intention-to-treat (ITT) dataset from the Company’s DUBLIN-3 Phase 3 registrational trial of their first-in-class lead asset, plinabulin, in combination with docetaxel vs. docetaxel alone for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) patients with EGFR wild type.
Title: A Global Phase (Ph) 3 Trial with the Plinabulin/Docetaxel (Plin/Doc) combination vs. Doc in 2nd/3rd Line NSCLC Patients (pts) with EGFR-wild type (wt) Progressing on a Prior Platinum-Based Regimen
Session: Proffered Paper session – NSCLC, metastatic 2
Date: September 20, 2021 from 2:10 – 2:20 p.m. CEST
Location: Channel 4
Presentation Number: LBA48
Speaker: Baohui Han, M.D., Ph.D, Professor in the Department of Respiratory Medicine, Shanghai Chest Hospital, China
“The ESMO Congress is the perfect venue to present high-impact clinical oncology findings such as data from our successful DUBLIN-3 study that demonstrates plinabulin’s ability to improve overall survival in 2nd/3rd line NSCLC patients,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring. “Importantly, the direct durable anti-cancer benefit shown by plinabulin in this study is a gateway to developing plinabulin as part of immuno-oncology combos in multiple cancer indications. In the coming months, BeyondSpring plans to apply for an NDA in the U.S. and China for the use of plinabulin in these NSCLC patients. This would add to the ongoing U.S. and China regulatory review of plinabulin in combination with G-CSF for the prevention of chemotherapy-induced neutropenia, which has a PDUFA date of November 30, 2021. We’ve had a tremendous year of milestones at BeyondSpring, and we are grateful to all of our collaborators for their great efforts in helping to bring plinabulin to cancer patients globally.”
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, is being developed as a “pipeline in a drug.” It is filed for approval and has received Priority Review in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021 in the U.S. Plinabulin and docetaxel combination has met the primary endpoint of extending overall survival in a global, randomized, active controlled Phase 3 study (DUBLIN-3) in 2nd/3rd line NSCLC (EGFR wild type). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Ashley R. Robinson
LifeSci Advisors, LLC
Darren Opland, Ph.D.