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ESMO 2025 | CheckMate 8HW: nivolumab & ipilimumab in MSI-H/dMMR metastatic CRC
Sara Lonardi, MD, Veneto Institute of Oncology, Padua, Itay, discusses the Phase III CheckMate 8HW trial (NCT04008030) of nivolumab plus ipilimumab versus nivolumab monotherapy in patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (CRC). Nivolumab and ipilimumab improved progression-free survival, overall survival, and objective response rates in the first-line setting and across all lines of therapy, with a manageable safety profile. These findings reinforce nivolumab plus ipilimumab as a preferred standard of care for MSI-H/dMMR metastatic CRC. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
Today I presented on behalf of all the authors the results of the CheckMate 8HW trial with a specific focus on the population treated in first line with the nivolumab plus ipilimumab over nivolumab monotherapy. The trial, as you already know, was positive having met both the dual primary endpoint of a superiority in PFS for nivolumab plus ipilimumab versus chemotherapy in first line and a superiority in PFS for nivolumab plus ipilimumab versus nivolumab alone across all lines of treatment...
Today I presented on behalf of all the authors the results of the CheckMate 8HW trial with a specific focus on the population treated in first line with the nivolumab plus ipilimumab over nivolumab monotherapy. The trial, as you already know, was positive having met both the dual primary endpoint of a superiority in PFS for nivolumab plus ipilimumab versus chemotherapy in first line and a superiority in PFS for nivolumab plus ipilimumab versus nivolumab alone across all lines of treatment. But actually, we are treating now the patients only in first line and so the comparison between the doublet and the mono immune checkpoint inhibitor, it was very relevant in the population of the first line and today we presented the new data addressing this specific question and demonstrating that nivolumab plus ipilimumab was able to improve progression-free survival compared to nivolumab alone with a reduction of the risk of progression or death of 31%. The benefit was consistent along all the curves, ranging from 10% to 13%. And at four years, we had 65% of the patients in the combination arm free of progression. This secondary endpoint is not formally statistically significant but the clinical relevance is huge and along with other data showing an improvement of 12% in the response rate with a higher number of complete response rates and lower number of disease progressions are reinforcing the concept that the doublet combination is more efficient compared to a monotherapy with the PD-1 inhibitor nivolumab. Today I also presented for the first time in a randomized trial overall survival across multiple lines of treatment, showing a benefit for nivolumab plus ipilimumab compared to nivolumab, with a reduction of the risk of death of 39%, starting from 7% of absolute benefit at one year, a long time reaching 13 percent and having four out of five patients with metastatic disease microsatellite instability at four years so all the burden of data for sure are indicating that a combination of nivolumab and ipilimumab in patients with advanced colorectal cancer, MSI high or dMMR is highly effective and it should be the preferred first-line treatment for this population.
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