Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): First results of the CheckMate 8HW study
Abstract
LBA768 Background: Patients (pts) with MSI-H/dMMR mCRC have poor outcomes with standard chemo ± targeted therapies. NIVO ± IPI are approved in previously treated pts with MSI-H/dMMR mCRC in many countries, based on the phase 2 CheckMate 142 study. CheckMate 8HW (NCT04008030) is a randomized phase 3 study comparing NIVO + IPI with NIVO or chemo in pts with MSI-H/dMMR mCRC. We report progression-free survival (PFS) by blinded independent central review (BICR) at a prespecified interim analysis for NIVO + IPI vs chemo in the 1L setting. Methods: Pts ≥ 18 years with recurrent or mCRC not amenable to surgery and MSI-H/dMMR status per local testing were enrolled across different lines of therapy. Previously untreated pts were randomized 2:2:1 to NIVO (240 mg) + IPI (1 mg/kg) Q3W (4 doses, then NIVO 480 mg Q4W), NIVO (240 mg) Q2W (6 doses, then NIVO 480 mg Q4W), or chemo ± targeted therapies; treatments continued until disease progression or unacceptable toxicity (all arms), or a maximum of 2 years (NIVO ± IPI arms). For pts with BICR-documented progression with chemo, optional crossover to NIVO + IPI was permitted. Dual primary endpoints were PFS by BICR per RECIST v1.1 for NIVO + IPI vs chemo (1L) and NIVO + IPI vs NIVO (all lines) in pts with centrally confirmed MSI-H/dMMR mCRC. Results: In the 1L setting, 303 pts were randomized to NIVO + IPI (n = 202) or chemo (n = 101); of these pts, 171 pts in the NIVO + IPI arm and 84 pts in the chemo arm had centrally confirmed MSI-H/dMMR result by either immunohistochemistry and/or polymerase chain reaction-based tests. With 24.3 months of median follow-up, NIVO + IPI demonstrated clinically meaningful and statistically significant improvement in PFS vs chemo, with a 79% reduction in the risk of disease progression or death (HR 0.21 [95% CI 0.14–0.32]; P < 0.0001) (Table). No new safety signals were identified (Table). Conclusions: NIVO + IPI demonstrated superior PFS vs chemo in previously untreated pts with MSI-H/dMMR mCRC. NIVO + IPI had a different safety profile compared to chemo, with fewer grade 3–4 treatment-related adverse events (TRAEs). These results support 1L NIVO + IPI as a standard-of-care option for pts with MSI-H/dMMR mCRC. Clinical trial information: NCT04008030 . [Table: see text]
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In another phase II study, the objective response rate with nivolumab-ipilimumab combination therapy in first-line treatment was 80% in the RAS mutant patient group.
“In another phase II study evaluating the effectiveness of nivolumab–ipilimumab combination therapy in first-line treatment, the objective response rate with combination immunotherapy was found to be 80% in the RAS mutant patient group [85].”
From RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches (2025) · cites this paper as [85]
Checkmate 8HW confirmed efficacy of dual ICB with ipilimumab and nivolumab in the first-line treatment of metastatic dMMR/MSI-H mCRC.
“Recent results from the Checkmate 8HW trial confirmed the outstanding efficacy of dual ICB with the anti-CTLA-4 antibody ipilimumab and the anti-PD-1 antibody nivolumab in the first-line treatment of metastatic dMMR/MSI-H mCRC,103”
From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [103]
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- Authors
- Andre, T., Elez, E., Van Cutsem, E., Jensen, L. H., Bennouna, J., Mendez, G., Schenker, M., De La Fouchardiere, C., Limon, M. L., Yoshino, T., Li, J., Lenz, H.-J., Manzano Mozo, J. L., Tortora, G., Garcia-Carbonero, R., Cela, E., Yang, Y., Lei, M., Jin, L., & Lonardi, S.
- Affiliations
- Sorbonne Université, and Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Paris, France
- Vall d’Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain
- University Hospitals Gasthuisberg and University of Leuven (KU Leuven), Leuven, Belgium
- Vejle Sygehus (DK)
- Centre Hospitalier Universitaire de Nantes (FR)
- Fundacion Favaloro Hospital Universitario (AR)
- Centrul de Oncologie Sf. Nectarie, Craiova, Romania
- Centre Léon Bérard, Lyon Cedex, France
- Hospital Universitario Virgen del Rocio, Sevilla, Spain
- National Cancer Center Hospital East (JP)
- Shanghai East Hospital (CN)
- USC Norris Comprehensive Cancer Center (US)
- Institut Català d'Oncologia, Badalona, Spain
- Agostino Gemelli University Polyclinic (IT)
- Hospital Universitario 12 de Octubre Imas12, UCM, Madrid, Spain
- Bristol-Myers Squibb (United States) (US)
- Istituto Oncologico Veneto (IT)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2024-01-20
- Volume
- 42
- Issue
- 3_suppl
- Pages
- LBA768-LBA768
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4391096773
- Cited by
- 63
- References
- 0
- Citations by year
- 2026: 6 · 2025: 28 · 2024: 29
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Funders
- Bristol Myers Squibb
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
- Keywords
- nivolumab, ipilimumab, metastatic colorectal cancer, MSI-H/dMMR, first-line therapy, immune checkpoint inhibitors, chemotherapy, progression-free survival, immune-related adverse events, predictive biomarkers, PD-L1 expression, tumor-infiltrating lymphocytes, tumor mutational burden, microsatellite instability, immune-related pneumonitis
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