What is the role of nivolumab in the treatment of colon cancer?

Updated: Apr 15, 2020
  • Author: Tomislav Dragovich, MD, PhD; Chief Editor: N Joseph Espat, MD, MS, FACS  more...
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Answer

In the CheckMate 142 phase 2 study, nivolumab, with or without ipilimumab, appeared tolerable and demonstrated clinical activity for patients with microsatellite instability-high metastatic colorectal cancer. The study enrolled dMMR and MSI-H colorectal cancer patients who had progressed on, or were intolerant to, at least one prior line of therapy. Patients were dosed with nivolumab every two weeks. [121]

The primary endpoint was investigator-assessed objective response rate (ORR), defined as the percentage of patients whose tumor shrank or disappeared. Secondary endpoint was independent review committee-assessed ORR. Other measures, including safety, progression-free survival (PFS), overall survival (PS), and effectiveness in specific subsets were also assessed.

Data revealed patients receiving nivolumab had the investigator-assessed ORR and disease control rate were 31% and 69%. One year after entering the trial, 48.4% of patients were still alive and disease-free. One-year overall survival was 73.8%. Treatment was well-tolerated with no safety signals.

Nivolumab monotherapy demonstrated encouraging activity in patients with microsatellite instability-high status. The study brought an accelerated approval to nivolumab for the treatment of patients 12 years or older with dMMR and MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan in August 2017. The accelerated approval of nivolumab for this indication is contingent upon the outcomes of confirmatory trials. [122]


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