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BeyondSpring’s Lead Asset, Plinabulin, Continues to Demonstrate Clinical Superiority Versus Standard of Care for Neutropenia
Phase 2 Data Show Plinabulin Significantly Reduces Thrombocytopenia in Docetaxel-Treated Patients Compared to Standard of Care
Data Presented at 2018
New data from the Company’s Phase 2 portion of the Phase 2/3 trial in Study 105 of Plinabulin was presented by Dr.
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, potentially resulting in a long ICU stay, as well as a high mortality rate.
In a head-to-head Phase 2 trial comparing Plinabulin with Neulasta® (pegfilgrastim), a long-acting G-CSF, Plinabulin at 20 mg/m2 (n=14) was shown to be effective in significantly reducing docetaxel-induced thrombocytopenia (p<0.001 to p<0.05 over different timepoints in Cycle 1), while Neulasta (n=14) did not show this benefit.
“The platelet protection data from this study further strengthens Plinabulin’s superior product profile compared to Neulasta through demonstrating anti-cancer activity, less bone pain and the benefit of same-day dosing, compared to next-day dosing with Neulasta,” said Dr. Blayney. “This further reinforces our confidence in the novel mechanism of action for Plinabulin, and we look forward to interim data from the Phase 3 portion of the study by the end of 2018 or early 2019.”
About Study 105
Plinabulin was given as a single dose per cycle 30 minutes after docetaxel chemotherapy, while Neulasta was given 24 hours after docetaxel chemotherapy, consistent with its approved product label. The Phase 2 portion met its primary endpoint, which was to determine the recommended Phase 3 Plinabulin dose, and the Phase 3 trial is now underway.
About Chemotherapy-Induced Neutropenia (CIN)
The current standard of care for CIN prevention is G-CSF, which accelerates the maturation and proliferation of neutrophil precursors. G-CSFs have serious limitations due to the excruciating bone pain that they may cause in some patients. In addition, G-CSFs may require patients to revisit the oncology clinic the day after chemotherapy, causing a significant inconvenience for some patients. Despite these setbacks, global sales for G-CSFs totaled more than
According to the CDC, approximately 650,000 patients receive outpatient chemotherapy in the U.S., and CIN remains a critical clinical problem despite 25+ years of G-CSF availability. Existing CIN therapies fail to address adverse events and efficacy issues that may cause doctors to lower target doses of chemotherapy (patients receive less than 85 percent of their target dose), end therapy early and / or delay chemotherapy cycles, each of which has a negative effect on long-term outcomes of cancer care.
Cautionary Note Regarding Forward-Looking Statements