Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study

Pembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study (NCT02628067)....

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Veröffentlicht in:	Journal of clinical oncology Jg. 40; H. 7; S. 752
Hauptverfasser:	O'Malley, David M, Bariani, Giovanni Mendonca, Cassier, Philippe A, Marabelle, Aurelien, Hansen, Aaron R, De Jesus Acosta, Ana, Miller, Jr, Wilson H, Safra, Tamar, Italiano, Antoine, Mileshkin, Linda, Xu, Lei, Jin, Fan, Norwood, Kevin, Maio, Michele
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.03.2022
Schlagworte:	Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents, Immunological - therapeutic use Biomarkers, Tumor - genetics DNA Mismatch Repair Endometrial Neoplasms - drug therapy Endometrial Neoplasms - genetics Endometrial Neoplasms - pathology Female Follow-Up Studies Humans Microsatellite Instability Middle Aged Non-Randomized Controlled Trials as Topic Prognosis Retrospective Studies Survival Rate
ISSN:	1527-7755, 1527-7755
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Abstract	Pembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study (NCT02628067). We report efficacy and safety outcomes for patients with MSI-H/dMMR endometrial cancer enrolled in KEYNOTE-158. Eligible patients from cohorts D (endometrial cancer, regardless of MSI-H/dMMR status) and K (any MSI-H/dMMR solid tumor, except colorectal) with previously treated, advanced MSI-H/dMMR endometrial cancer received pembrolizumab 200 mg once every 3 weeks for 35 cycles. The primary end point was objective response rate per RECIST version 1.1 by independent central radiologic review. Secondary end points included duration of response, progression-free survival, overall survival, and safety. As of October 5, 2020, 18 of 90 treated patients (20%) had completed 35 cycles of pembrolizumab and 52 (58%) had discontinued treatment. In the efficacy population (patients who received ≥ 1 dose of pembrolizumab and had ≥ 26 weeks of follow-up; N = 79), the median time from first dose to data cutoff was 42.6 (range, 6.4-56.1) months. The objective response rate was 48% (95% CI, 37 to 60), and median duration of response was not reached (2.9-49.7+ months). Median progression-free survival was 13.1 (95% CI, 4.3 to 34.4) months, and median overall survival was not reached (95% CI, 27.2 months to not reached). Among all treated patients, 76% had ≥ 1 treatment-related adverse event (grades 3-4, 12%). There were no fatal treatment-related events. Immune-mediated adverse events or infusion reactions occurred in 28% of patients (grades 3-4, 7%; no fatal events). Pembrolizumab demonstrated robust and durable antitumor activity and encouraging survival outcomes with manageable toxicity in patients with previously treated, advanced MSI-H/dMMR endometrial cancer.
AbstractList	Pembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study (NCT02628067). We report efficacy and safety outcomes for patients with MSI-H/dMMR endometrial cancer enrolled in KEYNOTE-158.PURPOSEPembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study (NCT02628067). We report efficacy and safety outcomes for patients with MSI-H/dMMR endometrial cancer enrolled in KEYNOTE-158.Eligible patients from cohorts D (endometrial cancer, regardless of MSI-H/dMMR status) and K (any MSI-H/dMMR solid tumor, except colorectal) with previously treated, advanced MSI-H/dMMR endometrial cancer received pembrolizumab 200 mg once every 3 weeks for 35 cycles. The primary end point was objective response rate per RECIST version 1.1 by independent central radiologic review. Secondary end points included duration of response, progression-free survival, overall survival, and safety.METHODSEligible patients from cohorts D (endometrial cancer, regardless of MSI-H/dMMR status) and K (any MSI-H/dMMR solid tumor, except colorectal) with previously treated, advanced MSI-H/dMMR endometrial cancer received pembrolizumab 200 mg once every 3 weeks for 35 cycles. The primary end point was objective response rate per RECIST version 1.1 by independent central radiologic review. Secondary end points included duration of response, progression-free survival, overall survival, and safety.As of October 5, 2020, 18 of 90 treated patients (20%) had completed 35 cycles of pembrolizumab and 52 (58%) had discontinued treatment. In the efficacy population (patients who received ≥ 1 dose of pembrolizumab and had ≥ 26 weeks of follow-up; N = 79), the median time from first dose to data cutoff was 42.6 (range, 6.4-56.1) months. The objective response rate was 48% (95% CI, 37 to 60), and median duration of response was not reached (2.9-49.7+ months). Median progression-free survival was 13.1 (95% CI, 4.3 to 34.4) months, and median overall survival was not reached (95% CI, 27.2 months to not reached). Among all treated patients, 76% had ≥ 1 treatment-related adverse event (grades 3-4, 12%). There were no fatal treatment-related events. Immune-mediated adverse events or infusion reactions occurred in 28% of patients (grades 3-4, 7%; no fatal events).RESULTSAs of October 5, 2020, 18 of 90 treated patients (20%) had completed 35 cycles of pembrolizumab and 52 (58%) had discontinued treatment. In the efficacy population (patients who received ≥ 1 dose of pembrolizumab and had ≥ 26 weeks of follow-up; N = 79), the median time from first dose to data cutoff was 42.6 (range, 6.4-56.1) months. The objective response rate was 48% (95% CI, 37 to 60), and median duration of response was not reached (2.9-49.7+ months). Median progression-free survival was 13.1 (95% CI, 4.3 to 34.4) months, and median overall survival was not reached (95% CI, 27.2 months to not reached). Among all treated patients, 76% had ≥ 1 treatment-related adverse event (grades 3-4, 12%). There were no fatal treatment-related events. Immune-mediated adverse events or infusion reactions occurred in 28% of patients (grades 3-4, 7%; no fatal events).Pembrolizumab demonstrated robust and durable antitumor activity and encouraging survival outcomes with manageable toxicity in patients with previously treated, advanced MSI-H/dMMR endometrial cancer.CONCLUSIONPembrolizumab demonstrated robust and durable antitumor activity and encouraging survival outcomes with manageable toxicity in patients with previously treated, advanced MSI-H/dMMR endometrial cancer. Pembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study (NCT02628067). We report efficacy and safety outcomes for patients with MSI-H/dMMR endometrial cancer enrolled in KEYNOTE-158. Eligible patients from cohorts D (endometrial cancer, regardless of MSI-H/dMMR status) and K (any MSI-H/dMMR solid tumor, except colorectal) with previously treated, advanced MSI-H/dMMR endometrial cancer received pembrolizumab 200 mg once every 3 weeks for 35 cycles. The primary end point was objective response rate per RECIST version 1.1 by independent central radiologic review. Secondary end points included duration of response, progression-free survival, overall survival, and safety. As of October 5, 2020, 18 of 90 treated patients (20%) had completed 35 cycles of pembrolizumab and 52 (58%) had discontinued treatment. In the efficacy population (patients who received ≥ 1 dose of pembrolizumab and had ≥ 26 weeks of follow-up; N = 79), the median time from first dose to data cutoff was 42.6 (range, 6.4-56.1) months. The objective response rate was 48% (95% CI, 37 to 60), and median duration of response was not reached (2.9-49.7+ months). Median progression-free survival was 13.1 (95% CI, 4.3 to 34.4) months, and median overall survival was not reached (95% CI, 27.2 months to not reached). Among all treated patients, 76% had ≥ 1 treatment-related adverse event (grades 3-4, 12%). There were no fatal treatment-related events. Immune-mediated adverse events or infusion reactions occurred in 28% of patients (grades 3-4, 7%; no fatal events). Pembrolizumab demonstrated robust and durable antitumor activity and encouraging survival outcomes with manageable toxicity in patients with previously treated, advanced MSI-H/dMMR endometrial cancer.
Author	Italiano, Antoine Jin, Fan Hansen, Aaron R Norwood, Kevin O'Malley, David M De Jesus Acosta, Ana Miller, Jr, Wilson H Cassier, Philippe A Xu, Lei Maio, Michele Mileshkin, Linda Bariani, Giovanni Mendonca Marabelle, Aurelien Safra, Tamar
Author_xml	– sequence: 1 givenname: David M orcidid: 0000-0002-2828-0177 surname: O'Malley fullname: O'Malley, David M organization: Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, Columbus, OH – sequence: 2 givenname: Giovanni Mendonca surname: Bariani fullname: Bariani, Giovanni Mendonca organization: Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo, Brazil – sequence: 3 givenname: Philippe A orcidid: 0000-0003-3857-1688 surname: Cassier fullname: Cassier, Philippe A organization: Department of Medical Oncology, Centre Léon Bérard, Lyon, France – sequence: 4 givenname: Aurelien orcidid: 0000-0002-5816-3019 surname: Marabelle fullname: Marabelle, Aurelien organization: Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Institut National de la Santé et de la Recherche Médicale (INSERM U1015), Gustave Roussy, Université Paris Saclay, Villejuif, France – sequence: 5 givenname: Aaron R orcidid: 0000-0002-2363-8707 surname: Hansen fullname: Hansen, Aaron R organization: Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada – sequence: 6 givenname: Ana surname: De Jesus Acosta fullname: De Jesus Acosta, Ana organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD – sequence: 7 givenname: Wilson H surname: Miller, Jr fullname: Miller, Jr, Wilson H organization: Departments of Oncology and Medicine, McGill University, Montreal, QC, Canada – sequence: 8 givenname: Tamar orcidid: 0000-0001-6910-6426 surname: Safra fullname: Safra, Tamar organization: Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 9 givenname: Antoine orcidid: 0000-0002-8540-5351 surname: Italiano fullname: Italiano, Antoine organization: Faculty of Medicine, University of Bordeaux, France – sequence: 10 givenname: Linda surname: Mileshkin fullname: Mileshkin, Linda organization: Peter MacCallum Cancer Centre and the Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia – sequence: 11 givenname: Lei surname: Xu fullname: Xu, Lei organization: Merck & Co, Inc, Kenilworth, NJ – sequence: 12 givenname: Fan surname: Jin fullname: Jin, Fan organization: Merck & Co, Inc, Kenilworth, NJ – sequence: 13 givenname: Kevin surname: Norwood fullname: Norwood, Kevin organization: Merck & Co, Inc, Kenilworth, NJ – sequence: 14 givenname: Michele orcidid: 0000-0002-0323-6321 surname: Maio fullname: Maio, Michele organization: Division of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, Department of Oncology, University Hospital of Siena, Siena, Italy
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/34990208$$D View this record in MEDLINE/PubMed
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PublicationTitle	Journal of clinical oncology
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Snippet	Pembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch...
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SubjectTerms	Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents, Immunological - therapeutic use Biomarkers, Tumor - genetics DNA Mismatch Repair Endometrial Neoplasms - drug therapy Endometrial Neoplasms - genetics Endometrial Neoplasms - pathology Female Follow-Up Studies Humans Microsatellite Instability Middle Aged Non-Randomized Controlled Trials as Topic Prognosis Retrospective Studies Survival Rate
Title	Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study
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