Study finds increased survival with nivolumab plus ipilimumab vs. chemo for metastatic colorectal cancer

For patients with microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) metastatic colorectal cancer who had not previously received systemic treatment, progression-free survival is longer with nivolumab plus ipilimumab than with chemotherapy, according to a study published online in the Nov. 27 issue of the New England Journal of Medicine.

Thierry Andre, M.D., from Sorbonne Université in Paris, and colleagues randomly assigned patients with unresectable or metastatic colorectal cancer and MSI-H or dMMR status according to local testing to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy with or without targeted therapies in a 2:2:1 ratio in a phase 3, open-label trial.

In this prespecified interim analysis, nivolumab plus ipilimumab was compared to chemotherapy. Overall, 303 patients who had not previously received systemic treatment were randomly assigned to receive nivolumab plus ipilimumab or chemotherapy; 255 of the patients had centrally confirmed MSI-H or dMMR tumors.

The researchers found that progression-free survival outcomes were significantly better with nivolumab plus ipilimumab than with chemotherapy at a median follow-up of 31.5 months (24-month progression-free survival, 72 versus 14% with nivolumab plus ipilimumab versus chemotherapy).

The restricted mean survival time was 10.6 months longer with nivolumab plus ipilimumab versus chemotherapy at 24 months, which was consistent with the primary analysis of progression-free survival. Grade 3 or 4 treatment-related adverse events occurred in 23 and 48% of patients in the nivolumab plus ipilimumab and chemotherapy groups, respectively.

“Progression-free survival outcomes with nivolumab plus ipilimumab were superior to those with chemotherapy in the first-line treatment of MSI-H or dMMR metastatic colorectal cancer,” the authors write.

The study was funded by Bristol Myers Squibb and Ono Pharmaceutical; Bristol Myers Squibb manufactures nivolumab and ipilimumab.

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