BeyondSpring’s Plinabulin Demonstrates Superior Quality of Life Over Pegfilgrastim in a Head-to-Head Comparison Trial for the Prevention of Neutropenia
Data to be Presented at IASLC 2019 World Conference on Lung Cancer
NEW YORK, Aug. 23, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the results of its head-to-head clinical trial for Study BPI-2358-105, accepted as an abstract titled, “Quality of Life (QoL) in Advanced NSCLC Patients Treated with Docetaxel and with Either Plinabulin or Pegfilgrastim for the Prevention of Neutropenia.” The poster (Abstract No. 2513) will be presented during the IASLC World Conference on Lung Cancer in Barcelona, Spain on September 8, 2019 from 9:45 a.m. - 6:00 p.m. local time.
In the Phase 2 portion of the Phase 2/3 study, a multicenter, randomized double-blind trial, all patients received docetaxel 75 mg/m2 on Day 1. Patients were randomly assigned one of three Plinabulin doses (5 mg/m2 [n=14], 10 mg/m2 [n=13] or 20 mg/m2 [n=14]) given by IV infusion 30 minutes after chemotherapy over four cycles, or the standard dose (6 mg) of Pegfilgrastim (Neulasta®) on Day 2. QoL was assessed with the validated health-related questionnaires before dose on Day 1 of each of the four cycles, prior to the study and at the end of treatment.
Previously, BeyondSpring reported in its Phase 3 study that Plinabulin at 20 mg/m2 or a 40 mg fixed dose – which is the commercial dose level for its intended NDA – has equal protection against severe chemotherapy-induced neutropenia (CIN) in comparison to Pegfilgrastim. BeyondSpring’s latest abstract reports that the 20 mg/m2 Plinabulin dose demonstrated a significant improvement in the QoL over four treatment cycles for global health status (p-value < 0.0001), symptom scale (p-value < 0.009) and summary score (p-value < 0.02). Moreover, there were significant improvements in the QoL of patients for fatigue (p-value <0.03), pain (p-value <0.03) and insomnia (p-value <0.05).
Plinabulin, in contrast to Pegfilgrastim and other G-CSFs, does not produce bone pain, which remains an unaddressed patient complaint with the use of Pegfilgrastim monotherapy.
“We measured patient reported outcomes (PRO) in our study, as PRO are increasingly recognized as important and valid by patients, regulatory agencies and payers. While this analysis is exploratory, these preliminary results are statistically and clinically significant and indicate improvements with Plinabulin in the QoL for patients being treated with docetaxel for advanced non-small cell lung cancer in addition to protecting against CIN,” said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at the Stanford University School of Medicine, who will be presenting the data at the conference.
“PRO are equally as important as validated clinical outcomes, and with Plinabulin we have created a treatment option that is effective for CIN prevention and improves the QoL for very sick patients,” added Dr. Ramon Mohanlal, Chief Medical Officer and Executive Vice President, Research and Development, BeyondSpring. “Our CIN program has now advanced into Phase 3, and as a company, we are preparing for the submission of NDAs in both China and the U.S. for CIN in the coming months.”
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.
Plinabulin, BeyondSpring’s lead asset, is a marine-derived small molecule that sequesters tubulin heterodimers in a differentiated manner from other agents in this class. 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 anticancer benefits of Plinabulin have been associated with positive effects on antigen presenting cells and T-cell activation, as well as to the direct killing of cancer cells. 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.
About Chemotherapy-Induced Neutropenia (CIN)
CIN is a common, often severe side effect that cancer patients who are undergoing treatment experience involving the destruction of neutrophils, which are a type of white blood cell and a patient’s first line of defense against infections. The current standard of care for CIN prevention is G-CSF monotherapy, which has serious limitations as described in its product information summary.
As many as 90 percent of patients who receive high-risk chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia [Lee et al., Annals of Surgical treatment and research 94(5): 223-228 (2018)]. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial / fungal infections and sepsis, which can require hospitalization and be fatal. Grade 4 CIN can have an adverse effect on chemotherapy administration and is usually considered a significant predictor of low relative dose intensity (RDI), dose delays and dose reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 – 179 (2017)]. Even a 15 percent chemotherapy dose reduction can reduce long-term survival by as much as 50 percent [Bonadonna, Med Oncol 29:1495–1501 (2012)].
Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients also report that the pain is severe. The National Comprehensive Cancer Network (NCCN) guidelines require that patients with grade 3 or 4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].
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.
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