Led by Thierry Andre, Head of the Department of Medical Oncology at the Hôpital Saint Antoine in Paris, the phase 3 open-label Checkmate 8HW trial evaluated first-line immunotherapy with nivolumab plus ipilimumab over chemotherapy in patients with microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) metastatic colorectal cancer (mCRC).
More than 1.9 million new cases of colorectal cancer (including anal cancers) and 904,000 deaths were estimated to occur in 2022, representing almost one in 10 cancer cases and deaths. Overall, colorectal cancer ranks in third place in terms of incidence but second in terms of mortality1. The overall 5-year survival rate for patients with metastatic disease is only 11%. Approximately 5-7% of patients diagnosed with mCRC have MSI-H or dMMR tumors.
The Checkmate 8HW study included a total of 303 patients with metastatic disease who had not previously received treatment. These patients were randomly assigned to receive immunotherapy with nivolumab plus ipilimumab or chemotherapy; among the 303 patients, 255 had confirmed MSI-H or dMMR tumors.
Recently published in The New England Journal of Medicine2 results show that at a median follow-up of 31.5 months, progression-free survival was significantly better in patients who received the nivolumab/ipilimumab combination than those who were treated with chemotherapy.
“At 24 months, progression-free survival was 72% with nivolumab plus ipilimumab as compared with 14% with chemotherapy. The restricted median survival time at 24 months was 10.6 months longer with the immunotherapy combination than with chemotherapy, demonstrating that this investigational immunotherapy duo delayed disease progression,” said Elena Élez, a Medical Oncologist at the Vall d’Hebron University Hospital, Head of VHIO’s Colorectal Cancer Group, and a co-author of this present study.
Grade 3 or 4 treatment-related adverse events occurred in 23% of the patients in the nivolumab plus ipilimumab group over 48% of the patients in the chemotherapy group.
“The next step should be to evaluate the efficacy of this combination versus single agent immunotherapy as first-line treatment, which is currently recommended in this patient population,” concluded Élez.
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References
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.
- Andre T, Elez E, Van Cutsem E, Jensen LH, Bennouna J, Mendez G, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Lenz HJ, Manzano Mozo JL, Tortora G, Garcia-Carbonero R, Dahan L, Chalabi M, Joshi R, Goekkurt E, Braghiroli MI, Cil T, Cela E, Chen T, Lei M, Dixon M, Abdullaev S, Lonardi S; CheckMate 8HW Investigators. Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. N Engl J Med. 2024 Nov 28;391(21):2014-2026.
