BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Phase 3 portion of its pivotal Study 105, evaluating its lead asset, Plinabulin, in the 105 enrolled patients treated with docetaxel chemotherapy, has met its primary endpoint of non-inferiority versus Neulasta® for the duration of severe neutropenia (DSN) of the first cycle, with statistical significance in a pre-specified interim analysis. In this trial, Plinabulin as a single agent was compared head-to-head with Neulasta as a single agent.
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 American Society of Hematology (ASH) Annual Meeting, BeyondSpring now has the necessary data to submit a new drug application (NDA) to the China Food and Drug Administration (China FDA) or National Medical Products Administration (NMPA), for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia (CIN). The Company is also on track to submit an NDA to the U.S. Food and Drug Administration (FDA) for the treatment of CIN. Both submissions will be for broad claims for the treatment of CIN in terms of type of chemotherapy as well as cancer type.
The double-blind, randomized Phase 3 portion of Study 105 was to enroll approximately 150 patients in the U.S., Europe and China with advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer (NSCLC), who were randomized to receive docetaxel (75 mg/m2), with either Plinabulin at a fixed dose of 40 mg on Day 1, or pegfilgrastim (Neulasta) at 6 mg on Day 2 of each 21-day treatment cycle. Plinabulin is administered on the same day of chemotherapy, 30 minutes after chemo administration. Neutrophil count and other hematological parameters were evaluated by Covance Central Laboratory. Covance is also the global clinical CRO for the study for patient enrollment. The primary endpoint of the study was the DSN in the first cycle. A pre-specified interim analysis following approximately 100 patients enrolled was built into the protocol study design to evaluate the primary endpoint of non-inferiority for DSN versus Neulasta.
“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. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University School of Medicine.
“This represents a significant milestone for BeyondSpring that illustrates the effectiveness of our development strategy and ability to deliver as promised and ahead of schedule. Coupled with the recently announced positive topline efficacy and safety data from Study 106, BeyondSpring is well-positioned to submit NDAs in both China and the U.S. in the near future, to address the unmet clinical needs of cancer patients,” added Dr. Lan Huang, CEO and co-founder at BeyondSpring.