Abstract
In LOTUS (NCT02162719), adding the oral AKT inhibitor IPAT to 1st-line PAC for mTNBC improved progression-free survival (PFS; primary endpoint) [Kim, Lancet Oncol 2017]. The stratified PFS hazard ratio in the intent-to-treat (ITT) population was 0.60 (95% CI 0.37–0.98; p=0.037; median PFS 6.2 vs 4.9 mo with IPAT vs PBO, respectively), with an enhanced effect in patients (pts) with PIK3CA/AKT1/PTEN-altered tumours. Overall survival (OS) results were immature at the primary and updated analyses (deaths in 21% and 55% of pts, respectively).
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