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Title: Seven-Year Follow-Up of the Phase III KEYNOTE-006 Study: Pembrolizumab Versus Ipilimumab in Advanced Melanoma.
Austin Authors: Robert, Caroline;Carlino, Matteo S;McNeil, Catriona;Ribas, Antoni;Grob, Jean-Jacques;Schachter, Jacob;Nyakas, Marta;Kee, Damien ;Petrella, Teresa M;Blaustein, Arnold;Lotem, Michal;Arance, Ana;Daud, Adil I;Hamid, Omid;Larkin, James;Anderson, James;Krepler, Clemens;Grebennik, Dmitri;Long, Georgina V
Affiliation: Gustave Roussy and Paris-Saclay University, Villejuif, France.
Melanoma Institute Australia, The University of Sydney, Westmead and Blacktown Hospitals, Sydney, NSW, Australia.
Chris O'Brien Lifehouse, Camperdown, NSW, Australia.
Jonsson Comprehensive Cancer Center at The University of California, Los Angeles (UCLA), Los Angeles, CA.
Aix-Marseille University, Hospital of the Timone, Marseille, France.
Sheba Medical Center-Tel HaShomer, Ramat Gan, Israel.
Oslo University Hospital, Oslo, Norway.
Austin Health
Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Mount Sinai Medical Center Comprehensive Cancer Center, Miami Beach, FL.
Sharett Institute of Oncology, Hadassah University Hospital Ein Kerem, Jerusalem, Israel.
Hospital Clinic Barcelona and IDIBAPS, Barcelona, Spain.
UCSF, San Francisco, CA.
The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, CA.
The Royal Marsden NHS Foundation Trust, London, United Kingdom.
Merck & Co, Inc, Rahway, NJ.
Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.
Issue Date: 20-Aug-2023
Date: 2023
Publication information: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology 2023-08-20; 41(24)
Abstract: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Immune checkpoint inhibitors have led to unprecedented prolongation of overall survival (OS) for patients with advanced melanoma. Five-year follow-up of KEYNOTE-006 showed pembrolizumab prolonged survival versus ipilimumab. Efficacy results with 7-year follow-up are presented. At data cutoff (April 19, 2021), median follow-up was 85.3 months (range, 0.03-90.8 months). Median OS was 32.7 months for pembrolizumab versus 15.9 months for ipilimumab (hazard ratio [HR], 0.70; 95% CI, 0.58 to 0.83); 7-year OS was 37.8% and 25.3%, respectively. OS HRs favored pembrolizumab regardless of BRAF status or prior BRAF/MEK-inhibitor treatment and prognostic characteristics (elevated lactate dehydrogenase, large tumor size, and brain metastasis). Median modified progression-free survival (mPFS) was 9.4 months for pembrolizumab versus 3.8 months for ipilimumab; 7-year mPFS was 23.8% and 13.3%, respectively. In patients who completed ≥94 weeks of pembrolizumab, the 5-year OS was 92.9% and the 5-year mPFS was 70.1%. The objective response rate with second-course pembrolizumab (n = 16) was 56% (95% CI, 30 to 80) and the 2-year mPFS was 62.5%. These findings confirm that pembrolizumab provides long-term survival benefit in advanced melanoma.
DOI: 10.1200/JCO.22.01599
ORCID: 0000-0002-9493-0238
Journal: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Start page: JCO2201599
PubMed URL: 37348035
ISSN: 1527-7755
Type: Journal Article
Appears in Collections:Journal articles

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