BeyondSpring’s Lead Asset, Plinabulin, Shows Superior Efficacy Compared to Neulasta for Prevention of Thrombocytopenia Induced by Docetaxel in Phase 2 Trial
Data Provide Further Support for Plinabulin’s Superior Product Profile
Clinical Data Will be Presented at 2018 IASLC 19th World Conference on Lung Cancer
NEW YORK , Sept. 06, 2018 (GLOBE NEWSWIRE) -- . (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, will present clinical trial data on its lead asset, Plinabulin, during a poster presentation titled, “Plinabulin, a Novel Immuno-Oncology Agent Mitigates Docetaxel Chemotherapy-Induced Neutropenia and Thrombocytopenia in NSCLC Patients” at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer. The conference will take place on Sept. 23 through 26, 2018, in Toronto, Canada.
The data demonstrated that Plinabulin, a novel, non-G-CSF small molecule in development for the prevention of chemotherapy-induced neutropenia (CIN) and for the treatment of non-small cell lung cancer (NSCLC), mitigated both docetaxel CIN and thrombocytopenia in patients with advanced NSCLC. Thrombocytopenia, a frequent side effect of chemotherapy, is a lowering of platelet counts that, when severe, leads to bleeding and anemia and can require transfusion with platelets.
- Plinabulin is administered as a single IV infusion 30 minutes after chemotherapy. Plinabulin at dose of 20 mg/m2 (the dose level that will be carried forward into Phase 3) prevented docetaxel-induced thrombocytopenia significantly in cycle 1 (p < 0.001 to 0.05 at different timepoints) and over all four cycles of the study (p < 0.02).
“These promising data show that Plinabulin – not Neulasta – prevented thrombocytopenia, which is an important added clinical benefit with Plinabulin that we didn’t see in the Neulasta treatment arm,” said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and the founding member of NCCN guidelines of neutropenia management in US. “In clinical trials to date, Plinabulin has a more convenient dosing schedule and avoid bone pain compared to Neulasta, and now has shown to prevent chemotherapy-induced platelet reduction as well. I look forward to seeing results from BeyondSpring’s large-scale Phase 3 study to confirm Plinabulin’s distinctive profile in the prevention of CIN.”
“In clinical trials, Plinabulin has demonstrated therapeutic effect as a cancer supportive care drug in preventing CIN and as an anti-cancer agent. We believe Plinabulin’s unique mechanism of action and therapeutic profile provide compelling evidence for its utility in a range of oncology indications, both as a standalone therapy and with potential to augment immunological effects as a combination with existing immuno-oncology agents,” added Dr. Ramon Mohanlal, Executive Vice President and Chief Medical Officer at BeyondSpring. “The data announced today are very encouraging and reveal additional facets to the emerging therapeutic profile for Plinabulin. We look forward to multiple important data readouts in the near future for both CIN and NSCLC to add to the totality of data supporting Plinabulin’s differentiated profile.”
The poster presentation will take place during Session P1.01 on Sept. 24, 2018, from 9:45 a.m. to 6 p.m. ET at the Metro Toronto Convention Centre North Building in the Exhibit Hall.
About Plinabulin
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in NSCLC. Studies of Plinabulin's mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to up-regulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia by reducing the neutrophil breakdown.
About Chemotherapy-Induced Neutropenia (CIN)
CIN is a common side effect in cancer patients that involves the destruction of a type of white blood cell (neutrophil), which are a patient’s first line of defense against infections. Patients with severe, or grade 4, neutropenia have an abnormally low concentration of neutrophils, making them more susceptible to severe bacterial and fungal infections and sepsis, which can require hospitalization. When severe neutropenia occurs, the chemotherapy dose has to be reduced or interrupted until the neutropenia subsides. Up to 18 percent of patients could die from first-cycle chemotherapy treatment, according to Cancer Network. The severity of neutropenia is measured by DSN, which measures the days a patient has a dangerously low neutrophil count. DSN of less than one day is considered clinically meaningful.
The current standard of care for prevention of CIN is G-CSF, which accelerates maturation and proliferation of neutrophil precursors, and, when administered the day after chemotherapy, reduces DSN of docetaxel to less than one day. G-CSF has the limitation of second-day dosing after chemotherapy treatment and bone pain in some patients, with some patients citing bone pain as “excruciating.” For the intermediate-risk chemotherapy market, which represents 60 percent of cases, National Comprehensive Cancer Network (NCCN) guidelines recommend G-CSF treatment only in limited, patient-specific circumstances.
Global sales of G-CSF totaled more than $8 billion in 2017, with the current G-CSF market leader, Neulasta, contributing approximately $6 billion. In the U.S., Neulasta sales totaled more than $4 billion in 2016. According to the CDC, about 650,000 patients receive outpatient chemotherapy in the U.S. Approximately 4 million new patients are diagnosed with cancer in China each year, according to the American Cancer Journal of Clinicians, and up to 65 percent of patients use chemotherapy, according to a nationwide study.
About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with University of Washington in de novo drug discovery using a ubiquitination platform. 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 a seasoned management team with many years of experience bringing drugs to the global market.
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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