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Purpose  To model absolute neutrophil count (ANC) suppression in response to acute radiation (AR) exposure and evaluate ANC time course as a predictor of overall survival (OS) in response to AR exposure with or without treatment with granulocyte colony-stimulating factor in nonhuman primates.    Methods  Source data were obtained from two pivotal studies conducted in rhesus macaques exposed to 750 cGy of whole body irradiation on day 0 that received either placebo, daily filgrastim, or pegfilgrastim (days 1 and 8 after irradiation). Animals were observed for 60 days with ANC measured every 1 to 2 days. The population model of ANC response to AR and the link between observed ANC time course and OS consisted of three submodels characterizing injury due to radiation, granulopoiesis, and a time-to-event model of OS.    Results  The ANC response model accurately described the effects of AR exposure on the duration of neutropenia. ANC was a valid surrogate for survival because it explained 76% (95% CI, 41%–97%) and 73.2% (95% CI, 38.7%–99.9%) of the treatment effect for filgrastim and pegfilgrastim, respectively.    Conclusion  The current model linking radiation injury to neutropenia and ANC time course to OS can be used as a basis for translating these effects to humans.    Electronic supplementary material  The online version of this article (10.1007/s11095-020-02839-3) contains supplementary material, which is available to authorized users.

pharmaceutical research

Quantification of Radiation Injury on Neutropenia and the Link between Absolute Neutrophil Count Time Course and Overall Survival in Nonhuman Primates Treated with G-CSF