NEW YORK, Sept. 29, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology therapies to transform the lives of patients with unmet medical needs, today announced that the Company’s manuscript, titled “Efficacy of Plinabulin vs. Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Adults With Non-Small Cell Lung Cancer,” has been published in JAMA Oncology, the American Medical Association’s peer-reviewed journal.
The manuscript analyzed BeyondSpring’s Phase 2 portion of its PROTECTIVE-1 (Study 105) randomized clinical trial, which consisted of four treatment arms and was conducted in 19 treatment centers in the U.S., China, Russia and Ukraine from April 2017 through March 2018, with Covance serving as its contract research organization. Key primary and secondary endpoints were calculated using objective data, such as the absolute neutrophil count and platelet counts, which were based on validated assays conducted at Covance’s central labs in three continents. Participants were adult patients with non-small cell lung cancer (NSCLC) whose cancer had progressed after platinum-based chemotherapy. The objective was to assess the efficacy and safety of the Company’s lead asset, Plinabulin, compared with Pegfilgrastim, a long-lasting G-CSF, which is currently the predominant therapy for chemotherapy-induced neutropenia (CIN) prevention.
The protocols were as follows:
- All NSCLC patients (n=55) received docetaxel (75 mg/m2) on Day 1 and were randomly assigned to four arms: three dose levels of Plinabulin (5, 10 or 20 mg/m2) monotherapy on Day 1 or Pegfilgrastim (6 mg) monotherapy on Day 2. Patients were treated every 21 days for four chemotherapy cycles.
Key results included:
- Plinabulin’s CIN effect in terms of Grade 4 frequency was dose-dependent, and the 20 mg/m2 (or 40 mg fixed dose) was selected as the Phase 3 dose.
- Plinabulin as a single agent was equally effective as Pegfilgrastim for preventing Grade 4 neutropenia and infections.
- In contrast to Pegfilgrastim, patients who received Plinabulin maintained their overall quality of life (p<0.001) and experienced significantly less bone pain and less thrombocytopenia.
“The data presented demonstrates that Plinabulin – a novel, non-G-CSF small molecule with anticancer activity – has potent neutropenia prevention effects,” said Dr. Douglas Blayney, Principal Investigator of BeyondSpring’s CIN program with Plinabulin. “The results show the promise that Plinabulin has to deliver relief to cancer patients suffering around the world.”
“The results of this study validate Plinabulin’s strength and its potent ability to prevent CIN in cancer patients,” added Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development. “This study, coupled with the breakthrough designation granted to our CIN program from both the U.S. FDA and China NMPA, is highly encouraging for our pending New Drug Application filings in both countries.”
To access the full e-publication, please visit: https://jamanetwork.com/journals/jamaoncology/article-abstract/2770700.
Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen dose’s decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a “pipeline drug,” Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed “molecular glue” that uses the protein degradation pathway.
Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.
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.