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dc.contributor.authorCarlino, Matteo S-
dc.contributor.authorMenzies, Alexander M-
dc.contributor.authorAtkinson, Victoria-
dc.contributor.authorCebon, Jonathan S-
dc.contributor.authorJameson, Michael B-
dc.contributor.authorFitzharris, Bernard M-
dc.contributor.authorMcNeil, Catriona M-
dc.contributor.authorHill, Andrew G-
dc.contributor.authorRibas, Antoni-
dc.contributor.authorAtkins, Michael B-
dc.contributor.authorThompson, John A-
dc.contributor.authorHwu, Wen-Jen-
dc.contributor.authorHodi, F Stephen-
dc.contributor.authorGuminski, Alexander D-
dc.contributor.authorKefford, Richard-
dc.contributor.authorWu, Haiyan-
dc.contributor.authorIbrahim, Nageatte-
dc.contributor.authorHomet Moreno, Blanca-
dc.contributor.authorLong, Georgina V-
dc.identifier.citationClinical Cancer Research 2020; 26(19): 5086-5091en
dc.description.abstractCombination 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.en
dc.titleLong-term Follow-up of Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Patients with Advanced Melanoma: KEYNOTE-029 Part 1B.en
dc.typeJournal Articleen
dc.identifier.journaltitleClinical Cancer Researchen
dc.identifier.affiliationDepartment of Clinical Medicine, Macquarie University, Macquarie Park, New South Wales, Australiaen
dc.identifier.affiliationDepartment of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australiaen
dc.identifier.affiliationMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australiaen
dc.identifier.affiliationDepartment of Medicine, Blacktown Hospital, Blacktown, New South Wales, Australiaen
dc.identifier.affiliationDepartment of Medicine, Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, New South Wales, Australiaen
dc.identifier.affiliationDepartment of Medical Oncology, Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australiaen
dc.identifier.affiliationDepartment of Medical Oncology, Gallipoli Medical Research Foundation, Greenslopes Private Hospital, University of Queensland, Greenslopes, Queensland, Australiaen
dc.identifier.affiliationOlivia Newton-John Cancer Research Instituteen
dc.identifier.affiliationSchool of Cancer Medicine, La Trobe University, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationMedical Oncologyen
dc.identifier.affiliationDepartment of Medical Oncology, Tasman Health Care, Gold Coast University Hospital, Southport, Queensland, Australiaen
dc.identifier.affiliationRegional Cancer Centre, Waikato Hospital, and Waikato Clinical Campus, University of Auckland, Hamilton, New Zealanden
dc.identifier.affiliationCanterbury Regional Cancer & Haematology Service, Christchurch Hospital, Christchurch, New Zealanden
dc.identifier.affiliationDepartment of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, Californiaen
dc.identifier.affiliationDepartment of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington, DCen
dc.identifier.affiliationDepartment of Medicine, Seattle Cancer Care Alliance, University of Washington, Seattle, Washingtonen
dc.identifier.affiliationDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texasen
dc.identifier.affiliationDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusettsen
dc.identifier.affiliationDepartment of Clinical Oncology, MSD China, Beijing, Chinaen
dc.identifier.affiliationDepartment of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jerseyen
dc.identifier.affiliationClinical Haematologyen
dc.identifier.pubmedid32605909, Jonathan S
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
item.openairecristype Newton-John Cancer Research Institute-
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