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Title: Long-Term Follow-Up of Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Patients With Advanced Melanoma: KEYNOTE-029 Part 1B.
Austin Authors: Carlino, Matteo S;Menzies, Alexander M;Atkinson, Victoria G;Cebon, Jonathan S ;Jameson, Michael B;Fitzharris, Bernard M;McNeil, Catriona M;Hill, Andrew Graham;Ribas, Antoni;Atkins, Michael B;Thompson, John A;Hwu, Wen-Jen;Hodi, F Stephen;Guminski, Alexander;Kefford, Richard F;Wu, Haiyan;Ibrahim, Nageatte;Homet Moreno, Blanca;Long, Georgina V
Affiliation: Medicine, Melanoma Institute Australia, The University of Sydney, Blacktown Hospital, and Crown Princess Mary Cancer Centre, Westmead Hospital
Melanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitals
Division of Cancer Services, University of Queensland
Cancer Immunobiology, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
Oncology Department, Waikato Hospital
Canterbury Regional Cancer & Haematology Service, Christchurch Hospital
Medical Oncology, Chris O'Brien Lifehouse
Oncology, Tasman Oncology Research
Department of Medicine, Jonsson Comprehensive Cancer Center at University of California, Los Angeles, Los Angeles
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Medicine/Medical Oncology, University of Washington
Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center
Medical Oncology, Dana-Farber Cancer Institute
Medicine, Royal North Shore Hospital
Clinical Medicine, Macquarie University
Department of Clinical Oncology, MSD China
Oncology, Merck Research Laboratories
Merck & Co., Inc
Medical Oncology, Melanoma Institute Australia, University of Sydney
Issue Date: 30-Jun-2020 2020-06-30
Publication information: Clinical Cancer Research 2020; online first: 30 June
Abstract: Combination therapy with reduced-dose programmed death 1 inhibitor plus standard-dose cytotoxic T-lymphocyte-associated antigen 4 inhibitor demonstrated efficacy, but substantial toxicity, in melanoma. We present long-term results of part 1B of KEYNOTE-029, which assessed safety and efficacy of standard-dose pembrolizumab plus reduced-dose ipilimumab in advanced melanoma. -Part 1B was an expansion cohort of the open-label, phase Ib portion of KEYNOTE-029. Eligible patients had advanced melanoma and no previous immune checkpoint inhibitor therapy. Patients received pembrolizumab 2 mg/kg (amended to 200 mg) every 3 weeks plus ipilimumab 1 mg/kg every 3 weeks (four cycles), then pembrolizumab alone for up to 2 years. Primary end point was safety; secondary end points included objective response rate (ORR), progression-free survival (PFS), duration of response (DOR), and overall survival (OS). -A total of 153 patients received at least one dose of pembrolizumab plus ipilimumab. At a median follow-up of 36.8 months, 71.9% had received four doses of ipilimumab and 30.7% had completed 2 years of pembrolizumab; 26.1% completed both treatments. Treatment-related adverse events occurred in 96.1% (47.1% grade 3/4; no deaths), leading to discontinuation of one or both study drugs in 35.9%. ORR was 62.1% with 42 (27.5%) complete and 53 (34.6%) partial responses. Median DOR was not reached; 36-month ongoing response rate was 84.2%. Median PFS and OS were not reached; 36-month rates were 59.1% and 73.4%, respectively. -Standard-dose pembrolizumab plus reduced-dose ipilimumab demonstrated robust antitumor activity, durable response, and favorable long-term survival with manageable toxicity.
DOI: 10.1158/1078-0432.CCR-20-0177
ORCID: 0000-0002-3898-950X
PubMed URL: 32605909
ISSN: 1078-0432
Type: Journal Article
Appears in Collections:Journal articles

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