On August 31, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported a late-breaking oral presentation at the European Society for Medical Oncology 2021 Congress taking place virtually September 16-21, 2021 (Press release, BeyondSpring Pharmaceuticals, AUG 31, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-late-breaking-oral-presentation-of-final-phase-3-dublin-3-data-with-the-plinabulin-docetaxel-combination-versus-docetaxel-alone-in-2nd-3rd-line-non-small-cell-lung-cancer-patien [SID1234587036]). 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.
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Additional Details:
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 (Free ESMO Whitepaper) 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."
About Plinabulin
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.