Cited by 729Cancer Immunotherapy and BiomarkersColorectal Cancer Treatments and StudiesGenetic factors in colorectal cancer

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First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study

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Lenz, Heinz-Josef, Van Cutsem, Eric, Luisa Limon, Maria, Wong, Ka Yeung Mark, Hendlisz, Alain, Aglietta, Massimo, García-Alfonso, Pilar, Neyns, Bart, Luppi, Gabriele, Cardin, Dana B., Dragovich, Tomislav, Shah, Usman, Abdullaev, Sandzhar, Gricar, Joseph, Ledeine, Jean-Marie, Overman, Michael James, Lonardi, Sara·2022·Journal of Clinical Oncology

DOI 10.1200/jco.21.01015

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Abstract

PURPOSE: Nivolumab received US Food and Drug Administration approval as a single agent or in combination with ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) that progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan based on CheckMate 142. Presented are results of nivolumab plus low-dose ipilimumab in the first-line therapy cohort from the phase II CheckMate 142 study. PATIENTS AND METHODS: Patients with no prior treatment in the metastatic setting for MSI-H/dMMR CRC were treated with nivolumab every 2 weeks plus low-dose ipilimumab every 6 weeks until disease progression. The primary end point was objective response rate (investigator assessment; RECIST v1.1). RESULTS: Median age of treated patients was 66 years (N = 45). Median follow-up was 29.0 months. Objective response rate and disease control rate were 69% (95% CI, 53 to 82) and 84% (95% CI, 70.5 to 93.5), respectively, with 13% complete response rate. Median duration of response was not reached; 74% of responders had ongoing responses at data cutoff. Median progression-free survival and median overall survival were not reached with minimum follow-up of 24.2 months (24-month rates, 74% and 79%, respectively). Clinical benefit was observed regardless of baseline demographic and tumor characteristics, including BRAF or KRAS mutation status. In a post hoc analysis, of 14 patients who discontinued treatment and did not receive subsequent therapy, 10 remained progression-free. Patient-reported outcomes were stable over the treatment period. Grade 3-4 treatment-related adverse events occurred in 22% of patients; 13% discontinued because of any-grade treatment-related adverse events. CONCLUSION: Nivolumab plus low-dose ipilimumab demonstrated robust and durable clinical benefit and was well tolerated as a first-line treatment for MSI-H/dMMR mCRC. Based on these promising data, randomized studies are warranted.

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2020, Opdivo (nivolumab) Injection for Intravenous Use [prescribing information]
National Comprehensive Cancer Network, Colon Cancer (Version 2.2021)
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Nivolumab plus low-dose ipilimumab as first-line therapy in microsatellite instability-high/DNA mismatch repair deficient metastatic colorectal cancer: Clinical update.
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Lenz, H., Lonardi, S., Zagonel, V., Cutsem, E. V., Limón, M. L., Wong, M. K., Hendlisz, A., Aglietta, M., Alfonso, P. G., Neyns, B., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.2020.38.15_suppl.4040 · Cited by 43
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Authors: Lenz, H.-J., Van Cutsem, E., Luisa Limon, M., Wong, K. Y. M., Hendlisz, A., Aglietta, M., García-Alfonso, P., Neyns, B., Luppi, G., Cardin, D. B., Dragovich, T., Shah, U., Abdullaev, S., Gricar, J., Ledeine, J.-M., Overman, M. J., & Lonardi, S.
Affiliations: USC Norris Comprehensive Cancer Center (US)
University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven, Belgium
Hospital Universitario Virgen del Rocio, Sevilla, Spain
Westmead Hospital (AU)
Institut Jules Bordet (BE)
Candiolo Cancer Institute (IT)
Hospital General Universitario Gregorio Marañón (ES)
Universitair Ziekenhuis Brussel (BE)
University of Modena and Reggio Emilia (IT)
Vanderbilt University (US)
Banner MD Anderson Cancer Center (US)
Lehigh Valley Cancer Institute, Allentown, PA
Bristol-Myers Squibb (United States) (US)
The University of Texas MD Anderson Cancer Center (US)
Istituto Oncologico Veneto (IT)
ORCID: Lenz, Heinz-Josef
Van Cutsem, Eric
Luisa Limon, Maria
Hendlisz, Alain
Aglietta, Massimo
Neyns, Bart
Cardin, Dana B.
Overman, Michael James
Lonardi, Sara
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2022-01-10
Volume: 40
Issue: 2
Pages: 161-170
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.21.01015
OpenAlex: W3206775306
Semantic Scholar: 2e81a9ea94ac646baf31c284ca8497f8b3df6f0e
Cited by: 728
References: 30
Citations by year: 2026: 125 · 2025: 148 · 2024: 182 · 2023: 173 · 2022: 93
FWCI: 41.26
Type: journal article
Language: en
Open access: green
biblio.vub.ac.be
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Lirias (submittedVersion)
Funders: Bristol-Myers Squibb
Agilent Technologies (PD-L1 IHC 28-8)
Ono Pharmaceutical
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
Keywords: nivolumab, ipilimumab, metastatic colorectal cancer, microsatellite instability-high, mismatch repair deficiency, first-line therapy, immune checkpoint inhibitors, combination immunotherapy, objective response rate, progression-free survival, treatment-related adverse events
MeSH terms: Ipilimumab, Nivolumab, Progression-Free Survival, Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Time Factors, Colorectal Neoplasms, Disease Progression, Microsatellite Instability, DNA Mismatch Repair, Young Adult

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First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study

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