Updated data confirm the long-term clinical benefits of nivolumab plus low-dose ipilimumab for previously treated patients with microsatellite instability high/mismatch repair-deficient (MSI-H/dMMR) recurrent or metastatic colorectal cancer (CRC), according to researchers. These phase 2 data were published in the Annals of Oncology.
The phase 2 CheckMate 142 trial (ClinicalTrials.gov Identifier: NCT02060188) enrolled adults with histologically confirmed recurrent or metastatic CRC classified as MSI-H and/or dMMR. Eligible patients had disease progression on or after therapy or were intolerant to at least 1 prior systemic treatment.
Per study protocol, patients received intravenous nivolumab at 3 mg/kg (60-minute infusion) and low-dose ipilimumab at 1 mg/kg (90-minute infusion) once every 3 weeks for 4 total doses, followed by nivolumab at 3 mg/kg every 2 weeks until disease progression, discontinuation, or study conclusion.
A total of 119 patients were treated. The median age at baseline was 58 (range, 21-88) years, 58% of patients were men, 92% were White, and 76% had at least 2 prior lines of treatment. The median follow-up was 50.9 (range, 46.9-62.7) months. The median treatment duration was 24.9 months.
The investigator-assessed objective response rate increased from 55% at 13.4 months to 65% at 50.9 months. Overall, 13% of patients had a complete response, 52% had partial response, 21% had stable disease, and 12% had progressive disease.
Most patients (81%) had disease control for at least 12 weeks. The median time to response was 2.8 (range, 1.1-37.1) months from the first infusion. The median duration of response and median progression-free survival were not reached.
No new safety signals or treatment-related deaths were observed during follow-up. Treatment-related adverse events were reported in 85% of patients, the most common of which were diarrhea (27%) and pruritis (21%). Discontinuation due to adverse events occurred in 13% of patients.
These long-term follow-up data support the continued clinical benefit of nivolumab plus low-dose ipilimumab in previously treated patients with MSI-H/dMMR recurrent or metastatic CRC, according to researchers. Study limitations include the lack of a comparator group. Further study with a randomized design is underway.
“Nivolumab plus low-dose ipilimumab provided durable clinical benefit over 4 years of follow-up, characterized by high response rates, low rates of disease progression, and long-term survival benefit,” the researchers wrote.
Disclosures: This research was supported by Bristol-Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
André T, Lonardi S, Wong KYM, et al. Nivolumab plus low-dose ipilimumab in previously treated patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: 4-year follow-up from CheckMate 142. Ann Oncol. Published online June 25, 2022. doi:10.1016/j.annonc.2022.06.008
This article originally appeared on Gastroenterology Advisor