CanStem111P

Between January 2017 and February 2019, 1,779 patients were screened and 1,134 randomised (565 napabucasin, 569 control), 206 and 176 of them biomarker-positive. Median overall survival was 11.4 months (95 percent confidence interval 10.5 to 12.2) with napabucasin against 11.7 months (10.7 to 12.7) with chemotherapy alone (hazard ratio 1.07, 0.93 to 1.23), with no difference in the phospho-STAT3-positive subgroup, and the trial was terminated for futility. Grade 3 or worse adverse events occurred in 85.4 against 83.9 percent, with more gastrointestinal events on napabucasin (diarrhoea 11.6 against 4.9 percent; abdominal pain 10.0 against 4.8). The 11.7-month control-arm survival, higher than MPACT's 8.5 months, reflects fitter trial populations and better supportive care a decade on, and is the yardstick against which NAPOLI 3's 9.2-month control arm is often compared.