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BeyondSpring’s Plinabulin Continues to Build on Superior Product Profile in Breast Cancer Trial for Neutropenia Prevention
In Study 106,
BeyondSpring’s data shows that the increasing Pegfilgrastim doses caused a statistically significant dose-dependent increase in thrombocytopenia (p<0.0001 for all grade thrombocytopenia). At the standard dose of Pegfilgrastim (6 mg), the frequency of grades 1, 2 and 3 thrombocytopenia were 56 percent, 19 percent, and 19 percent, respectively. The frequency of grades 1, 2 and 3 thrombocytopenia in the Plinabulin (20mg/m2) treatment arm were 20 percent, 7 percent and 0 percent, which is similar to the frequency of thrombocytopenia reported with the use of TAC chemotherapy, without the use of either Pegfilgrastim or Plinabulin.
“While we know that breast cancer patients who receive chemotherapy treatment experience both neutropenia and thrombocytopenia, Pegfilgrastim itself, which is given to patients to help prevent neutropenia, seems to exacerbate chemotherapy induced thrombocytopenia,” said Dr.
“As a single agent, Plinabulin appears to have a superior product profile over Pegfilgrastim. When we combine Plinabulin with Pegfilgrastim, we create a superior treatment regimen that is more effective for CIN than either agent alone, while improving on the product characteristics of Pegfilgrastim alone. Not only does Plinabulin have anticancer activity, but it reduces bone pain and an immune-suppressive neutrophil profile caused by Pegfilgrastim. To date, BeyondSpring’s studies have proven time and time again that Plinabulin has a differentiated mechanism of action from Pegfilgrastim, and by combining the two agents, we can combat CIN better, and provide superior supportive care than each of the agents alone,” added Dr.
About Chemotherapy-Induced Neutropenia (CIN)
As many as 90 percent of patients who receive high-risk chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia [Lee et al., Annals of Surgical treatment and research 94(5): 223-228 (2018)]. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial / fungal infections and sepsis, which can require hospitalization and be fatal. Grade 4 CIN can have an adverse effect on chemotherapy administration and is usually considered a significant predictor of low relative dose intensity (RDI), dose delays and dose reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 – 179 (2017)]. Even a 15 percent chemotherapy dose reduction can reduce long-term survival by as much as 50 percent [Bonadonna, Med Oncol 29:1495–1501 (2012)].
Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients also report that the pain is severe. The National Comprehensive Cancer Network (NCCN) guidelines require that patients with grade 3 or 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 [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].
Cautionary Note Regarding Forward-Looking Statements
Source: BeyondSpring, Inc.