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Long-term Follow-up of Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Patients with Advanced Melanoma: KEYNOTE-029 Part 1B.
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
  • Carlino MS; Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia. matteo.carlino@sydney.edu.au.
  • Menzies AM; Department of Medicine, Blacktown Hospital, Blacktown, New South Wales, Australia.
  • Atkinson V; Department of Medicine, Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, New South Wales, Australia.
  • Cebon JS; Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.
  • Jameson MB; Department of Medical Oncology, Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.
  • Fitzharris BM; Department of Medical Oncology, Gallipoli Medical Research Foundation, Greenslopes Private Hospital, University of Queensland, Greenslopes, Queensland, Australia.
  • McNeil CM; Department of Hematology and Oncology, Olivia Newton John Cancer Research Institute, Heidelberg, Victoria, Australia.
  • Hill AG; School of Cancer Medicine, La Trobe University, Heidelberg, Victoria, Australia.
  • Ribas A; Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia.
  • Atkins MB; Regional Cancer Centre, Waikato Hospital, and Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand.
  • Thompson JA; Canterbury Regional Cancer & Haematology Service, Christchurch Hospital, Christchurch, New Zealand.
  • Hwu WJ; Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.
  • Hodi FS; Department of Medical Oncology, Tasman Health Care, Gold Coast University Hospital, Southport, Queensland, Australia.
  • Guminski AD; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California.
  • Kefford R; Department of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.
  • Wu H; Department of Medicine, Seattle Cancer Care Alliance, University of Washington, Seattle, Washington.
  • Ibrahim N; Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Homet Moreno B; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Long GV; Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.
Clin Cancer Res ; 26(19): 5086-5091, 2020 10 01.
Article in En | MEDLINE | ID: mdl-32605909
PURPOSE: 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. PATIENTS AND METHODS: 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). RESULTS: 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. CONCLUSIONS: Standard-dose pembrolizumab plus reduced-dose ipilimumab demonstrated robust antitumor activity, durable response, and favorable long-term survival with manageable toxicity.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / CTLA-4 Antigen / Ipilimumab / Melanoma Type of study: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2020 Document type: Article Affiliation country: Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / CTLA-4 Antigen / Ipilimumab / Melanoma Type of study: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2020 Document type: Article Affiliation country: Country of publication: