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BeyondSpring to Present Positive Data From Prospective Phase 2 Trial Comparing Plinabulin to Neulasta for the Prevention of Chemotherapy-Induced Neutropenia at 2018 ASCO Annual Meeting
Study 105 is part of BeyondSpring’s comprehensive development program for Plinabulin for the prevention of CIN. The Phase 2/3 study was designed as a head-to-head comparison of different dose levels of Plinabulin to Neulasta in a total of 55 patients. 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. Data from the Phase 2 portion, to be included in the poster presentation, are summarized below.
Similar Neutropenia Reduction
Plinabulin-Treated Patients Reported Two-Thirds Lower Rate of Bone Pain
Plinabulin Preserved Neutrophil Number in
“The Phase 2 data are extremely encouraging and underscore Plinabulin’s potential to address unmet needs in the treatment of CIN. These prospective data suggest that Plinabulin, given as a single dose per cycle, would be at least as effective as Neulasta, with the important benefit of causing less bone pain and enabling same-day dosing, compared with the next-day dosing per the G-CSF label. The neutrophil levels observed in this trial are also noteworthy, suggesting a different mechanism of action for Plinabulin compared with G-CSF,” said Dr.
“These are the first head-to-head comparison data between Plinabulin and Neulasta. We are highly encouraged by these Phase 2 trial results, and subject to confirmatory Phase 3 trial data, we plan to submit a New Drug Application (NDA) for CIN to the
“The CIN program with Plinabulin further illustrates BeyondSpring’s potential and our commitment to bringing first-in-class drugs to the market to serve important areas with unmet medical needs,” concluded Dr.
ASCO Poster Presentation on
About Chemotherapy-Induced Neutropenia (CIN)
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.
Cautionary Note Regarding Forward-Looking Statements
Neulasta is a registered trademark of