BeyondSpring's e-poster presentation, titled, "Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial," compares Plinabulin versus Neulasta as a monotherapy for CIN prevention.
Additionally, BeyondSpring's e-publication, titled, "Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin)," demonstrates the efficacy of BeyondSpring's Plinabulin-Neulasta combination in increasing CD34+ counts for patients.
E-Poster: Plinabulin's strength further solidified in head-to-head PROTECTIVE-1 trial with Plinabulin versus Neulasta.
In BeyondSpring's PROTECTIVE-1 (Study 105) Phase 3 trial, non-small cell lung, hormone-refractory prostate and breast cancer patients were randomized to receive either 40mg of Plinabulin (on Day 1; n=53) or 6mg of Neulasta (on Day 2; n=52), with Duration of Severe Neutropenia (DSN) as the primary endpoint. The trial aims to demonstrate non-inferiority of Plinabulin versus Neulasta.
"The National Comprehensive Cancer Network (NCCN) recently updated its guidelines considering COVID-19 as a risk factor," said Dr. Ramon Mohanlal, BeyondSpring's Chief Medical Officer and Executive Vice President, Research and Development. "It recommends that intermediate-risk patients be considered for prophylactic CIN therapy, in addition to the high-risk population, to minimize hospital and ER visits from cancer patients experiencing neutropenia due to myelosuppressive chemotherapies. This guideline change represents a potential increase of more than 100 percent in the addressable U.S. patient population, according to our recent market research. BeyondSpring previously reported that the non-inferiority primary endpoint of the PROTECTIVE-1 Phase 3 trial was met at a pre-specified interim analysis. In addition, Plinabulin has a superior profile compared to long- or short-acting G-CSF therapies with its dosing on the same day as chemotherapy and its avoidance of bone pain and thrombocytopenia, which meets the NCCN's objective of minimizing healthcare touches and the risk of contracting COVID-19 by these cancer patients."
E-Publication: When combined with Plinabulin, low-dose Neulasta increased CD34+ counts and resulted in fewer adverse events for patients.
In clinical practice for CD34+ progenitor stem cell mobilization, the standard-dose of Neulasta at 6mg is often reduced to a low-dose at 3mg due to intolerable and unwanted side effects1. The low-dose of Neulasta is, however, less effective than the standard dose for CD34+ cell mobilization. In BeyondSpring's PROTECTIVE-2 (Study 106) Phase 2 trial for CIN prevention for breast cancer patients receiving TAC (taxotere, doxorubicin and cyclophosphamide) chemotherapy, BeyondSpring analyzed whether adding Plinabulin to low-dose Neulasta at 3mg or 1.5mg would maintain CD34+ cell mobilization efficacy at the level of the standard dose of Neulasta, while still avoiding unwanted side effects from this standard dose.
The data shows that the low dose of Neulasta + Plinabulin had comparable efficacy in terms of blood CD34+ counts but reported fewer cases of bone pain, myalgia (muscle pain) and leukocytosis (high white blood cell count) side effects, compared with the standard dose of Neulasta alone at 6mg.
1 Pardee, T. S et al. Journal of Applied Research, 6(3), 196-200 (2006)
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring's lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, 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. BeyondSpring is headquartered in New York City.
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.
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