113 of 115 enrolled patients underwent timely surgery; two had surgery delayed by more than two weeks
By Elana Gotkine HealthDay Reporter
WEDNESDAY, June 5, 2024 (HealthDay News) — Neoadjuvant nivolumab plus ipilimumab has an acceptable safety profile in patients with locally advanced mismatch repair-deficient (dMMR) colon cancer, according to a study published in the June 6 issue of the New England Journal of Medicine.
Myriam Chalabi, M.D., Ph.D., from the Netherlands Cancer Institute in Amsterdam, and colleagues conducted a phase 2 study involving patients with nonmetastatic, locally advanced, previously untreated dMMR colon cancer treated with neoadjuvant nivolumab plus ipilimumab. Safety, defined by timely surgery, and three-year disease-free survival were the two primary end points.
The researchers found that 113 of the 115 enrolled patients underwent timely surgery; two had surgery delayed by more than two weeks. In five patients (4 percent), grade 3 or 4 immune-related adverse events occurred; no patients discontinued treatment due to adverse events. A pathological response occurred in 98 percent of the 111 patients included in the efficacy analysis, including 95 and 68 percent with a major pathological response and a pathological complete response, respectively (defined as ≤10 and 0 percent residual viable tumor). No patients had disease recurrence during a median follow-up of 26 months.
“The high proportion of patients with a pathological response observed after only four weeks of treatment in our study, together with the safety profile, may provide sufficient justification to provide immunotherapy to patients with radiographically assessed high-risk disease, especially if three-year disease-free survival data from this study are positive,” the authors write.
The study was funded by Bristol Myers Squibb, the manufacturer of nivolumab and ipilimumab.
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