biostudies-literatureUnknown28(12)Verset GMerck &amp; Co., Inc., Kenilworth, NJMerck Sharp &amp; Dohme Corp.<h4>Purpose</h4>KEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. We report results from KEYNOTE-224 (NCT02702414) cohort 2, which enrolled patients with advanced HCC and no prior systemic therapy.<h4>Patients and methods</h4>KEYNOTE-224 was an open-label, multicountry phase II trial. Eligible patients in cohort 2 had advanced HCC not amenable or refractory to locoregional therapy and not previously treated with systemic therapy. Patients received pembrolizumab 200 mg intravenously every 3 weeks for ≤2 years. Primary endpoint was objective response rate (ORR) by central imaging review per RECIST v1.1. Secondary endpoints included duration of response (DOR), disease cClinical cancer research : an official journal of the American Association for Cancer Research2547-2554https://www.ebi.ac.uk/biostudies/studies/S-EPMC9784157biostudies-literaturePembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial.PMC9784157Hatogai KWang AChan SLSiegel ABKnox JJQin SZhu AXBorbath IZagonel VKudo MPalmer DHVerset GSarker DChisamore MKarwal MKardosh AEdeline JVogel AOgasawara SStal PVerslype CCattan SDaniele BVan Vlierberghe HCheng ALFinn RSfalsePembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial.<h4>Purpose</h4>KEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. We report results from KEYNOTE-224 (NCT02702414) cohort 2, which enrolled patients with advanced HCC and no prior systemic therapy.<h4>Patients and methods</h4>KEYNOTE-224 was an open-label, multicountry phase II trial. Eligible patients in cohort 2 had advanced HCC not amenable or refractory to locoregional therapy and not previously treated with systemic therapy. Patients received pembrolizumab 200 mg intravenously every 3 weeks for ≤2 years. Primary endpoint was objective response rate (ORR) by central imaging review per RECIST v1.1. Secondary endpoints included duration of response (DOR), disease c2022-01-01T00:00:00Z2022 Jun2026-05-28T03:45:32.627Z2025-04-06T00:53:05.483ZS-EPMC97841573542122810.1158/1078-0432.CCR-21-3807