Cited by 3,099Cancer Immunotherapy and BiomarkersColorectal Cancer Treatments and StudiesGenetic factors in colorectal cancer

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Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer

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André, Thierry, Shiu, Kai-Keen, Kim, Tae Won, Jensen, Benny Vittrup, Jensen, Lars Henrik, Punt, Cornelis, Smith, Denis, Garcia-Carbonero, Rocio, Benavides, Manuel, Gibbs, Peter, de la Fouchardiere, Christelle, Rivera, Fernando, Elez, Elena, Bendell, Johanna, Le, Dung T., Yoshino, Takayuki, Van Cutsem, Eric, Yang, Ping, Farooqui, Mohammed Z.H., Marinello, Patricia, Diaz, Luis A.·2020·New England Journal of Medicine

DOI 10.1056/nejmoa2017699

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Abstract

BACKGROUND: Programmed death 1 (PD-1) blockade has clinical benefit in microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) tumors after previous therapy. The efficacy of PD-1 blockade as compared with chemotherapy as first-line therapy for MSI-H-dMMR advanced or metastatic colorectal cancer is unknown. METHODS: In this phase 3, open-label trial, 307 patients with metastatic MSI-H-dMMR colorectal cancer who had not previously received treatment were randomly assigned, in a 1:1 ratio, to receive pembrolizumab at a dose of 200 mg every 3 weeks or chemotherapy (5-fluorouracil-based therapy with or without bevacizumab or cetuximab) every 2 weeks. Patients receiving chemotherapy could cross over to pembrolizumab therapy after disease progression. The two primary end points were progression-free survival and overall survival. RESULTS: At the second interim analysis, after a median follow-up (from randomization to data cutoff) of 32.4 months (range, 24.0 to 48.3), pembrolizumab was superior to chemotherapy with respect to progression-free survival (median, 16.5 vs. 8.2 months; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.80; P = 0.0002). The estimated restricted mean survival after 24 months of follow-up was 13.7 months (range, 12.0 to 15.4) as compared with 10.8 months (range, 9.4 to 12.2). As of the data cutoff date, 56 patients in the pembrolizumab group and 69 in the chemotherapy group had died. Data on overall survival were still evolving (66% of required events had occurred) and remain blinded until the final analysis. An overall response (complete or partial response), as evaluated with Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was observed in 43.8% of the patients in the pembrolizumab group and 33.1% in the chemotherapy group. Among patients with an overall response, 83% in the pembrolizumab group, as compared with 35% of patients in the chemotherapy group, had ongoing responses at 24 months. Treatment-related adverse events of grade 3 or higher occurred in 22% of the patients in the pembrolizumab group, as compared with 66% (including one patient who died) in the chemotherapy group. CONCLUSIONS: Pembrolizumab led to significantly longer progression-free survival than chemotherapy when received as first-line therapy for MSI-H-dMMR metastatic colorectal cancer, with fewer treatment-related adverse events. (Funded by Merck Sharp and Dohme and by Stand Up to Cancer; KEYNOTE-177 ClinicalTrials.gov number, NCT02563002.).

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Authors: André, T., Shiu, K.-K., Kim, T. W., Jensen, B. V., Jensen, L. H., Punt, C., Smith, D., Garcia-Carbonero, R., Benavides, M., Gibbs, P., de la Fouchardiere, C., Rivera, F., Elez, E., Bendell, J., Le, D. T., Yoshino, T., Van Cutsem, E., Yang, P., Farooqui, M. Z. H., Marinello, P., & Diaz, L. A.
Affiliations: University College Hospital (GB)
From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) — all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) — both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam ...
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
ORCID: André, Thierry
Shiu, Kai-Keen
Kim, Tae Won
Jensen, Benny Vittrup
Jensen, Lars Henrik
Punt, Cornelis
Smith, Denis
Benavides, Manuel
Gibbs, Peter
Rivera, Fernando
Bendell, Johanna
Le, Dung T.
Yoshino, Takayuki
Yang, Ping
Farooqui, Mohammed Z.H.
Diaz, Luis A.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2020-12-03
Volume: 383
Issue: 23
Pages: 2207-2218
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2017699
OpenAlex: W3110528877
Cited by: 3,099
References: 27
Citations by year: 2026: 522 · 2025: 536 · 2024: 526 · 2023: 587 · 2022: 554 · 2021: 367 · 2020: 4
FWCI: 136.81
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, other-oa)
Lirias (submittedVersion, other-oa)
Pure Amsterdam UMC (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
HAL (submittedVersion)
Digital Access to Libraries (submittedVersion, other-oa)
RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
Funders: Merck (N/A)
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: pembrolizumab, microsatellite instability-high, mismatch repair deficiency, advanced colorectal cancer, metastatic colorectal cancer, anti-PD-1 therapy, immunotherapy, first-line therapy, 5-fluorouracil chemotherapy, bevacizumab, cetuximab, progression-free survival, overall survival, treatment-related adverse events, immune-related adverse events
MeSH terms: Antineoplastic Agents, Immunological, Progression-Free Survival, Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Female, Fluorouracil, Humans, Male, Middle Aged, Mutation, Neoplastic Syndromes, Hereditary, Biomarkers, Tumor, Colorectal Neoplasms, Kaplan-Meier Estimate, Microsatellite Instability, Antibodies, Monoclonal, Humanized

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Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer

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