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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;Cebon, Jonathan S ;Jameson, Michael B;Fitzharris, Bernard M;McNeil, Catriona M;Hill, Andrew G;Ribas, Antoni;Atkins, Michael B;Thompson, John A;Hwu, Wen-Jen;Hodi, F Stephen;Guminski, Alexander D;Kefford, Richard;Wu, Haiyan;Ibrahim, Nageatte;Homet Moreno, Blanca;Long, Georgina V
Affiliation: Department of Clinical Medicine, Macquarie University, Macquarie Park, New South Wales, Australia
Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia
Department of Medicine, Blacktown Hospital, Blacktown, New South Wales, Australia
Department of Medicine, Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, New South Wales, Australia
Department of Medical Oncology, Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia
Department of Medical Oncology, Gallipoli Medical Research Foundation, Greenslopes Private Hospital, University of Queensland, Greenslopes, Queensland, Australia
Olivia Newton-John Cancer Research Institute
School of Cancer Medicine, La Trobe University, Heidelberg, Victoria, Australia
Medical Oncology
Department of Medical Oncology, Tasman Health Care, Gold Coast University Hospital, Southport, Queensland, Australia
Regional Cancer Centre, Waikato Hospital, and Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand
Canterbury Regional Cancer & Haematology Service, Christchurch Hospital, Christchurch, New Zealand
Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California
Department of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC
Department of Medicine, Seattle Cancer Care Alliance, University of Washington, Seattle, Washington
Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts
Department of Clinical Oncology, MSD China, Beijing, China
Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jersey
Clinical Haematology
Issue Date: 1-Oct-2020
Date: 2020-06-30
Publication information: Clinical Cancer Research 2020; 26(19): 5086-5091
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
Journal: Clinical Cancer Research
PubMed URL: 32605909
Type: Journal Article
Appears in Collections:Journal articles

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