Exposure–response analysis for key efficacy endpoints
Ph+
REGRESSION
Overall, the observed responses for cumulative MMR and cumulative CCyR were similar across the three studies evaluated in the exposure‐response analysis. MMR was achieved in 68% of patients in BELA, 74% in BFORE and 70% in B1871048. CCyR was achieved in 80% of patients in BELA and B1871048, and 83% in BFORE. Using pooled data across all three studies, the predicted bosutinib exposures were higher in patients with an MMR or CCyR response compared to those without a response (Table Metrics of bosutinib exposure in PK‐evaluable patients by MMR and CCyR response and non‐response.Abbreviations: AUC, area under the concentration‐time curve; AUCA total of 573 patients were included in the exposure–response analysis of cumulative MMR.Only Ph+ patients were included in the analysis of cumulative CCyR (A significant exposure–response relationship was identified between bosutinib exposures of log(Final logistic regression equation for cumulative MMR:Final logistic regression equation for cumulative CCyR:To better illustrate the probability of achieving MMR and CCyR in relation to bosutinib exposures, Figure Predicted probability of achieving (A) cumulative MMR with 