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Neoadjuvant Nivolumab Plus Ipilimumab Showed Promise Among Patients With Locally Advanced Mismatch-Repair Deficient Colon Cancer
According to results from the phase 2 NICHE-2 trial, neoadjuvant nivolumab plus ipilimumab showed promising safety and response results among patients with locally advanced mismatch repair-deficient (dMMR) colon cancer.
“In these patients, the efficacy of chemotherapy is limited,” stated Myriam Chalabi, MD, PhD, Netherlands Cancer Institute, Amsterdam, Netherlands, and coauthors. “The use of neoadjuvant immunotherapy has shown promising results, but data from studies of this approach are limited.”
In this study, 115 previously untreated patients with non-metastatic, locally advanced dMMR colon cancer received nivolumab plus ipilimumab followed by surgical resection. The primary end points were safety, defined by undergoing timely surgery ≤2 weeks following the planning period due to treatment-related adverse events and 3-year disease-free survival (DFS). A key secondary end point was pathological response.
Of the 115 patients, 113 underwent a timely surgery, with 2 patients having surgery delayed by more than 2 weeks. Grade 3/4 immune-related adverse events occurred in 5 patients. There were no incidences of treatment discontinuation due to adverse events. Pathological response was observed in 109 patients of the 111 included in the efficacy analysis, including 105 patients with a major pathological response (≤10% residual viable tumor) and 75 with a pathological complete response (0% residual viable tumor). At a median follow-up of 26 months, no patients experienced disease recurrence.
As Dr Chalabi et al concluded, “in patients with locally advanced dMMR colon cancer, neoadjuvant nivolumab plus ipilimumab had an acceptable safety profile and led to a pathological response in a high proportion of patients.”
Source:
Chalabi M, Verschoor YL, Tan PB, et al. Neoadjuvant immunotherapy in locally advanced mismatch repair–deficient colon cancer. N Engl J Med. Published online: June 5, 2024. doi: 10.1056/NEJMoa2400634
