BeyondSpring Abstract Demonstrating Bone Pain Benefit with Lead Asset, Plinabulin, versus Neulasta for Neutropenia Prevention Presented at ISPOR 2019
NEW YORK, May 20, 2019 (GLOBE NEWSWIRE) -- (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Company’s abstract on its lead asset, Plinabulin, has been accepted for poster presentation at the . ISPOR is internationally recognized as the leading educational and scientific organization for health economics and outcomes research (HEOR) and its use in healthcare decisions.
The data, derived from BeyondSpring’s Phase 2 Study 105, shows that Plinabulin at 20mg/m2 has a similar efficacy profile in reducing docetaxel-induced neutropenia as Neulasta 6mg (pegfilgrastim, the current standard of care), with the added safety benefit of avoiding the patient-reported bone pain that’s typically observed with Neulasta. BeyondSpring’s poster presentation will take place on May 20, 2019; display hours run from 10:30 a.m. to 2 p.m., and the discussion hour will take place from 1 to 2 p.m. local time.
Bone pain is a known side effect of Neulasta, and is different and distinct from the pain produced by metastatic cancer. BeyondSpring’s abstract, titled “Reduction in Patient-Reported Bone Pain with Plinabulin vs. Pegfilgrastim in Non-Small Cell Lung Cancer Patients Treated for the Prevention of Docetaxel-Induced Neutropenia,” evaluates this quality of life and safety endpoint prospectively in a randomized, open-label study of Plinabulin, compared with Neulasta, for the prevention of docetaxel-induced neutropenia in patients with advanced or metastatic non-small cell lung cancer. Patients were randomized to receive four 21-day cycles of docetaxel (75mg/m2) with either Neulasta at 6mg or Plinabulin at 5mg/m2, 10mg/m2 or 20 mg/m2. Forty-one patients completed the study in total.
When measuring “pain at its worst in the last 24 hours,” in patients with no pain at baseline (cycle 1 day 1), those on the 20mg/m2 Plinabulin arm reported minimal to no change in bone pain vs baseline, versus patients in the 6mg Neulasta arm who reported changes in bone pain beginning on Day 3. The pain also peaked on Day 7 before declining. Additionally, when measuring “pain on average,” patients in the 20mg/m2 Plinabulin arm showed an 8.3 percent increase on Day 5, but patients in the 6mg Neulasta arm exhibited an increase in pain starting on Day 3 – two days sooner. Similar results were observed for patients who had pre-existing bone pain – presumably from metastatic cancer – prior to any study treatment.
“Bone pain is a significant quality of life issue for patients who are undergoing chemotherapy treatment, and it is no longer acceptable to consider this the status quo,” said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at the Stanford University School of Medicine. “Plinabulin’s ability to not only achieve similar efficacy as Neulasta in preventing neutropenia, but also to significantly reduce bone pain for patients is a game-changer for both the industry and medical community at large, and these latest results reinforce the powerful potential of Plinabulin. In addition, studies have shown that Plinabulin is an anti-cancer agent, when added to Neulasta, it leads to a reversal of the immune-suppressive profile, which may have an important impact on patient outcomes, as maintaining an optimal immune response against cancer is very important for patient survival.”
The ISPOR 2019 Conference will take place on May 18 through 22 at the New Orleans Ernest N. Morial Convention Center in Louisiana. BeyondSpring’s abstract can be found on the ISPOR website .
About BeyondSpring
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 2/3 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.
About Plinabulin
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 mices. 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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