FDA Approves Nivolumab Plus Ipilimumab for MSI-H/dMMR Metastatic Colorectal Cancer

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This FDA approval is the first immuno-oncology combination therapy for MSI-H or dMMR mCRC.
This FDA approval is the first immuno-oncology combination therapy for MSI-H or dMMR mCRC.

The US Food and Drug Administration (FDA) granted approval to nivolumab plus ipilimumab for the treatment of patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC) who experienced disease progression after receiving fluoropyrimidine, irinotecan, and oxaliplatin.1

The approval marks the first immuno-oncology combination therapy for MSI-H or dMMR mCRC.

The FDA based its approval on evidence from the ongoing, nonrandomized CheckMate-142 phase 2 (ClinicalTrials.gov Identifier: NCT02060188) study, for which researchers treated 119 patients with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg. Eligible patients had histologically confirmed recurrent or metastatic colorectal cancer, and received at least 1 prior line of therapy.

Results showed that of the 82 patients who had been previously treated with fluoropyrimidine, irinotecan, and oxaliplatin, the overall response rate (ORR) was 46%, including complete response (CR) and partial response (PR) rates of 3.7% and 43%, respectively. The median duration of response was not reached among these patients;89% had responses lasting at least 6 months, and 21% had responses lasting for greater than 1 year.

Among all study participants, ORR was 49% with a CR of 4.2% and a PR of 45%. Of these responders, the median DOR was not reached as well; a response of at least 6 months and longer than 12 months was observed in 83% and 19% of patients respectively.

Warnings and precautions for nivolumab plus ipilimumab include colitis, encephalitis, endocrinopathies, hepatitis, immune-mediated pneumonitis, nephritis and renal dysfunction, and adverse reactions of the skin.

The trial is ongoing, and this FDA-accelerated approval is contingent upon additional verification and description of positive clinical benefit in confirmatory trials.


  1. Bristol-Myers Squibb's Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and... [press release]. Princeton, NJ; Bristol-Myers Squibb. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-low-dose-yervoy-ipilimu. Published July 11, 2018. Accessed July 11, 2018.

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