HR and 95% CIs were based on a stratified Cox regression model. Stratified log-rank tests were used to assess treatment group differences. PFS was estimated using the Kaplan-Meier method. Dual primary endpoints are PFS (RECIST v1.1, blinded independent central review) and OS by tumor PD-L1 expression (CPS ≥10 and ≥1) and in all pts. Pts were stratified by chemo type (taxane vs gemcitabine/carboplatin), PD-L1 status (CPS ≥1 vs <1), and prior (neo)adjuvant treatment with same-class chemo (yes vs no). Methods: Pts with ≥6 mo DFI were randomized 2:1 to pembro + chemo (nab-paclitaxel paclitaxel or gemcitabine/carboplatin) or pbo + chemo for up to 35 administrations of pembro/pbo or until progression/intolerable toxicity. KEYNOTE-355 (, NCT02819518) compared pembro + chemotherapy (chemo) vs placebo (pbo) + chemo for previously untreated locally recurrent inoperable or metastatic TNBC. IOB Institute of Oncology, Quiron Group & Vall d´Hebron Institute of Oncology (VHIO), Madrid & Barcelona, Spain Princess Margaret Cancer Centre, Toronto, ON, Canada University of California San Francisco Comprehensive Cancer Center, San Francisco, CA Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland Seoul National University Hospital, Seoul, South Korea Pantai Hospital, Kuala Lumpur, Malaysia Arturo Lopez Perez Foundation, Santiago, Chile Republican Clinical Oncology Dispensary of the Ministry of Public Health of Bashkortostan Republic, Ufa, Russian Federation Centro de Hematologia e Oncologia, Porto Alegre, Brazil Aichi Cancer Center Hospital, Nagoya, Japan National Hospital Organization, Osaka National Hospital, Osaka, Japan Oncomedica S.A., Monteria, Colombia Ege University Medical Faculty, Izmir, Turkey Peter MacCallum Cancer Institute, Melbourne, VIC, Australia Merck & Co., Inc., Kenilworth, NJ Barts Cancer Institute, Centre for Experimental Cancer Medicine, London, United Kingdomīackground: Pembrolizumab (pembro) monotherapy showed promising antitumor activity and manageable safety in patients (pts) with metastatic TNBC in KEYNOTE-012, -086 and -119.
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