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BeyondSpring Announces Phase 3 Study 105 of its Lead Asset Plinabulin for Chemotherapy-Induced Neutropenia Meets Primary Endpoint at Interim Analysis
Based on the results from this Phase 3 trial, as well as the top line data from the Phase 2 portion of Study 106 released at the recent
The double-blind, randomized Phase 3 portion of Study 105 was to enroll approximately 150 patients in the U.S.,
“Our Study 105 Phase 3 data with Plinabulin as a single agent compares well with Neulasta as a single agent for the prevention of CIN. Single agent Plinabulin had a superior product profile in regard to bone pain, thrombocytopenia protection, and a favorable, non-immunosuppressive phenotype in Study 105 Phase 2 data, which we presented at recent professional society meetings. These collective data demonstrate Plinabulin’s profile as an effective CIN prevention, with a superior product profile,” said Dr.
“This represents a significant milestone for
About Study 105 Phase 3
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.
About Chemotherapy-Induced Neutropenia
The current standard of care for chemotherapy-induced neutropenia prevention is G-CSF monotherapy. However, G-CSF monotherapy has limitations as described in its product information summary. As many as 90 percent of patients on chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia. Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain while on therapy. NCCN guidelines require that patients with grade 3/4 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.
Cautionary Note Regarding Forward-Looking Statements
Neulasta® is a registered trademark of