Efficacy
deaths, tumor
DISEASE, BEST, TUMOR
Sixty‐one of 99 patients enrolled (61.6%) were evaluable for response, and 38 patients (38.4%) did not have a post‐baseline scan and were considered non‐evaluable. Of these non‐evaluable patients, 8 (21.1%) were randomized but never treated, 21 (55.3%) died before imaging assessment, and 9 (23.7%) withdrew consent or refused follow‐up prior to the first disease response assessment.In the ITT population (Summary of best overall response (ITT population).
Abbreviations: CR, complete response; The best percentage change in tumor size relative to baseline was greater for those in Arm D than in any of the abemaciclib arms (Figure Best percentage change in tumor size in patients with measurable disease.Median PFS was 1.7 months (95% CI: 1.35–1.84) for abemaciclib, 1.8 months (95% CI: 1.28–1.91) for abemaciclib plus LY3023414, and 3.3 months (95% CI: 1.05–5.65) for SOC (Figure (A) Progression‐free survival in ITT population. (B) Overall survival in ITT population. ARM A, abemaciclib 200 mg; ARM B, abemaciclib 150 mg plus LY3023414; ARM D, SOC (gemcitabine or capecitabine); HR, Hazard Ratio; NC, not calculable. Hazard ratio was calculated using stratified Cox model with number of prior systemic therapy as the stratification factor. 2‐sided At the time of data cutoff, 22 deaths (66.7%) occurred in Arm A, 21 (63.6%) in Arm B, and 12 (36.4%) in Arm D. Median OS was 2.7 months (95% CI: 1.97–5.36) in Arm A and 3.3 months (95% CI: 1.97–5.03) in Arm B. Median OS was not reached in Arm D (Figure 