Safe Neoadjuvant Nivolumab, Ipilimumab for dMMR Colon Cancer

WEDNESDAY, June 5, 2024 — A recent study has demonstrated that combining neoadjuvant nivolumab and ipilimumab for treating locally advanced, mismatch repair-deficient (dMMR) colon cancer exhibits an acceptable safety profile. This study, detailed in the June 6th edition of the New England Journal of Medicine, was led by Dr. Myriam Chalabi of the Netherlands Cancer Institute in Amsterdam. The research forms part of a phase 2 trial focusing on patients with nonmetastatic, locally advanced, untreated dMMR colon cancer.

The investigation spotlighted two primary endpoints: the safety of the treatment, as determined by the ability to perform timely surgery, and the three-year disease-free survival rate. Safety was primarily assessed based on whether patients could undergo surgery within the expected timeframe.

Out of the 115 participants enrolled in the study, 113 underwent surgery as scheduled, with only two patients experiencing delays exceeding two weeks. The treatment's safety profile was further supported by the relatively low incidence of severe immune-related adverse events, with only 4 percent of patients (5 individuals) experiencing grade 3 or 4 events. Importantly, none of the patients had to discontinue treatment due to these adverse effects.

The efficacy of the treatment was also notable. A pathological response was observed in 98 percent of the 111 patients included in the efficacy analysis. Among these, 95 percent exhibited a major pathological response, defined as having 10 percent or less residual viable tumor. Furthermore, a remarkable 68 percent of patients achieved a complete pathological response, meaning there was no detectable viable tumor remaining. During a median follow-up period of 26 months, none of the patients experienced disease recurrence.

The authors of the study highlight the significant pathological responses observed after just four weeks of treatment. Combined with its favorable safety profile, this could provide a compelling reason to administer immunotherapy to patients identified as high-risk based on radiographic assessment. The anticipation of positive three-year disease-free survival data could further bolster the case for this treatment approach.

It is noteworthy that the study received funding from Bristol Myers Squibb, the pharmaceutical company responsible for producing both nivolumab and ipilimumab.

In conclusion, the combination of neoadjuvant nivolumab and ipilimumab shows promise as a safe and effective treatment option for patients with locally advanced dMMR colon cancer. The encouraging results regarding pathological responses and the absence of disease recurrence in the follow-up period suggest that this immunotherapy regimen could become a vital component of treatment for high-risk patients. Further data on long-term outcomes will be critical in confirming these preliminary findings.

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