Nivolumab and ipilimumab in metastatic colorectal cancer

In a new randomised, open-label phase 3 trial, recently published on The Lancet, the dual-agent immunotherapy with nivolumab plus ipilimumab shows efficacy and manageable safety versus single-agent immunotherapy for the treatment of microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.

CheckMate 8HW is the first phase 3, randomised trial to investigate the use of dual-agent immunotherapy versus single-agent immunotherapy in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. 707 patients mmunotherapy-naive adults with unresectable or metastatic colorectal cancer across different lines of therapy and microsatellite instability-high or mismatch repair-deficient status per local testing were randomly assigned to nivolumab plus ipilimumab, nivolumab or chemotherapy with or without targeted therapies. After a median follow-up of 47 months, nivolumab plus ipilimumab treatment showed a significantly higher response rate and significant and clinically meaningful improvement in progression-free survival versus nivolumab monotherapy (hazard ratio 0.62). A higher incidence of treatment-related adverse events was observed with nivolumab plus ipilimumab versus nivolumab; the safety profile of nivolumab plus ipilimumab was manageable and no new safety signals were reported. As authors say, «Coupled with the data from nivolumab plus ipilimumab versus chemotherapy in the first-line setting, these results support nivolumab plus ipilimumab as a potential new standard of care in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer».