BeyondSpring presents plinabulin data in DIN in NSCLC patients

BeyondSpring announced data from the ESMO Asia Congress 2022 and the American Society of Hematology Annual Meeting about the use of lead asset, plinabulin, for the prevention of docetaxel-induced neutropenia in non-small cell lung cancer patients. In addition, data was presented on plinabulin for the prevention of docetaxel-induced neutropenia in breast cancer at the 2022 San Antonio Breast Cancer Symposium. The analyses in the NSCLC studies support the efficacy of plinabulin as a monotherapy in reducing the mean duration of severe neutropeniawith a greater than1 day benefit for patients receiving docetaxel and plinabulin in two independent randomized trials. Title: Prevention of Docetaxel Induced Neutropenia with Single Agent Plinabulin Versus Control in Non-Small Cell Lung Cancer in Two Randomized Trials: The presentation summarized data from two randomized NSCLC studies, and DIN results were compared between the plinabulin arm and the control arm. The DSN was calculated based on Day 8 absolute neutrophil count values in the plinabulin and control arms. In NSCLC patients, docetaxel 75 mg/m2 is typically used without G-CSF prophylaxis. This analysis focuses on the effectiveness of plinabulin vs. control for the prevention of DIN in the 101 and 103 studies. In summary, in these two independent randomized studies, plinabulin demonstrated a superior benefit for Gr4N, Gr3/4N, all GrN and DSN compared to the control. Importantly, in both these randomized studies, there was a reduction in mean DSN of greater than1 day for plinabulin vs. control. Title: Superior single agent effectiveness with plinabulin versus placebo for docetaxel-induced neutropenia prevention in non-small cell lung cancer patients: The presentation summarized DIN data from a non-randomized comparison derived from two different studies: plinabulin data from study 105 and the control data from study 103. In the 105 study, NSCLC pts with at least one febrile neutropenia risk factor received docetaxel 75 mg/m2 with plinabulin. In the 103 study, patients received docetaxel 75 mg/m2 without plinabulin. In summary, plinabulin was superior for the prevention of DIN and hematologic complications vs control: Grade 4 Neutropenia: 17% with plinabulin vs 40% with placebo. In addition, the mean DSN was 0.43 days for plinabulin vs. 1.32 days for placebo. There was also a favorable quality of life and safety profile with plinabulin. Title: Superior effectiveness of Plinabulin versus no-treatment for Docetaxel-induced neutropenia and other hematologic complication in breast cancer patients: The presentation summarized DIN data for plinabulin from study 105 and the control data was taken from the literature. The hematologic complications endpoints from the 27 early breast cancer patients with at least one NCCN high FN risk factor from the Phase 3 portion of 105 study were compared with the no-treatment studies from literature where patients were given 75 mg/m2 docetaxel without G-CSF. Blood sampling in the no-treatment studies were infrequent and likely underestimated the true grade 4 neutropenia frequency. In summary, despite a higher frequency of ANC sampling in cycle 1, plinabulin was superior vs no-treatment for DIN and hematologic complications. Quality of life was maintained, and there were minimal adverse effects including minimal bone pain burden in the plinabulin arm vs. no-treatment.