The phase II CheckMate 142 trial has shown that nivolumab (Opdivo) produces durable responses in recurrent or metastatic DNA mismatch repair–deficient (dMMR)/microsatellite instability–high (MSI-H) colorectal cancer. These study findings were reported in The Lancet Oncology by Overman et al.
In this ongoing trial, 74 patients with recurrent or metastatic colorectal cancer locally assessed as dMMR/MSI-H from 31 sites in Australia, Belgium, Canada, France, Ireland, Italy, Spain, and the United States received nivolumab at 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. Patients had disease progression on or after or had been intolerant of at least one previous line of treatment, including a fluoropyrimidine and oxaliplatin or irinotecan. Overall, 54% of patients had received three or more previous treatments. The primary endpoint was investigator-assessed objective response.
At a median follow-up of 12.0 months, objective response had occurred in 23 patients (31.1%, all partial responses), with an additional 28 (37.8%) having stable disease for 12 weeks or longer. At the time of analysis, median duration of response had not been reached, with all responders remaining alive and 8 having responses of 12 months or longer. Twelve-month progression-free survival was 50%, and 12-month overall survival was 73%.
Grade 3 or 4 adverse events occurred in 54% of patients. The most common grade 3 or 4 treatment-related adverse events were increased lipase (8%) and increased amylase (3%). Treatment was discontinued due to drug-related adverse events in 8%. No deaths were considered to be related to study treatment.
The investigators concluded: “Nivolumab provided durable responses and disease control in pretreated patients with dMMR/MSI-H metastatic colorectal cancer and could be a new treatment option for these patients.”
The study was funded by Bristol-Myers Squibb.
Michael J. Overman, MD, of The University of Texas MD Anderson Cancer Center, is the corresponding author of The Lancet Oncology article.
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