Panagiotis A Konstantinopoulos, Su-Chun Cheng, Elizabeth K Lee, Alexandre André B A da Costa, Doga Gulhan, Andrea E Wahner Hendrickson, Bose Kochupurakkal, David L Kolin, Elise C Kohn, Joyce F Liu, Richard T Penson, Elizabeth H Stover, Jennifer Curtis, Hannah Sawyer, Madeline Polak, Dipanjan Chowdhury, Alan D D'Andrea, Anniina Färkkilä, Geoffrey I Shapiro, Ursula A Matulonis
PURPOSE: The multicenter, open-label, randomized phase 2 NCI-9944 study (NCT02595892) demonstrated that addition of ATR inhibitor (ATRi) berzosertib to gemcitabine increased progression-free survival (PFS) compared to gemcitabine alone (hazard ratio [HR]=0.57, one-sided log-rank P = .044, which met the one-sided significance level of 0.1 used for sample size calculation). METHODS: We report here the final overall survival (OS) analysis and biomarker correlations (ATM expression by immunohistochemistry, mutational signature 3 and a genomic biomarker of replication stress) along with post-hoc exploratory analyses to adjust for crossover from gemcitabine to gemcitabine/berzosertib...
April 2024: JCO Precision Oncology