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Tumor Immunotherapy

Tumor Immunotherapy

Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.

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Neoadjuvant Immunotherapy in Locally Advanced Mismatch Repair-Deficient Colon Cancer.

Myriam Chalabi¹, Yara L Verschoor¹, Pedro Batista Tan¹

¹From the Departments of Gastrointestinal Oncology (M.C., Y.L.V., P.B.T., C.G., S.D., N.V.B., I.L.H., M.E.V.L.), Medical Oncology (M.C., C.G., N.V.B., E.E.V., J.B.H.), Biometrics (S.B.), Surgery (B.A.G., K.K., G.L.B.), Pathology (P.S., J.G.B.), Molecular Oncology and Immunology (E.E.V., T.N.S.), and Radiology (R.G.B.-T.), and the Division of Molecular Carcinogenesis (L.F.W.), Netherlands Cancer Institute, and the Department of Gastroenterology and Hepatology, OLVG Hospital (A.U.V.L.), Amsterdam, the Department of Surgery, Catharina Hospital Eindhoven, Eindhoven (J.W.B.), the Department of Surgery, Haga Hospital, the Hague (T.S.A.), the Department of Surgery, Tergooi MC, Hilversum (E.R.H.), the Department of Surgery, Spaarne Gasthuis, Haarlem (S.J.O.), Oncode Institute, Utrecht (E.E.V., L.F.W., T.N.S.), the Faculty of EEMCS, Delft University of Technology, Delft (L.F.W.), GROW School for Oncology and Reproduction, Maastricht University, Maastricht (R.G.B.-T., G.L.B.), and the Departments of Gastroenterology and Hepatology (M.E.V.L.), Hematology (T.N.S.), and Medical Oncology (J.B.H.), Leiden University Medical Center, Leiden - all in the Netherlands; the Faculty of Medicine, University of Iceland, Reykjavik (P.S.); and the Melanoma Clinic, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (J.B.H.).

The New England Journal of Medicine

|June 5, 2024

Summary

Neoadjuvant nivolumab plus ipilimumab demonstrated a favorable safety profile in patients with locally advanced mismatch repair-deficient colon cancer. This immunotherapy combination achieved high pathological response rates, indicating significant tumor reduction with no observed disease recurrence in initial follow-up.

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Area of Science:

Oncology
Gastrointestinal Cancers
Immunotherapy

Background:

Mismatch repair-deficient (dMMR) colon cancer affects 10-15% of patients with nonmetastatic disease.
Chemotherapy efficacy is limited in dMMR colon cancer patients.
Neoadjuvant immunotherapy shows promise but requires further data.

Purpose of the Study:

To evaluate the safety and efficacy of neoadjuvant nivolumab plus ipilimumab in patients with nonmetastatic, locally advanced, previously untreated dMMR colon cancer.
To assess timely surgery rates and 3-year disease-free survival.
To explore pathological response and genomic analyses.

Main Methods:

Phase 2 study involving patients with locally advanced, untreated dMMR colon cancer.
Treatment with neoadjuvant nivolumab and ipilimumab.
Primary endpoints: safety (timely surgery) and 3-year disease-free survival; secondary endpoints: pathological response and genomic analyses.

Main Results:

98% of patients (113/115) underwent timely surgery; only 2 patients experienced delays.
4% (5/115) experienced Grade 3 or 4 immune-related adverse events, with no treatment discontinuations.
98% (109/111) showed a pathological response, including 95% with major pathological response and 68% with complete pathological response. No recurrences observed with median 26-month follow-up.

Conclusions:

Neoadjuvant nivolumab plus ipilimumab offers an acceptable safety profile for locally advanced dMMR colon cancer.
The combination therapy induced high pathological response rates in this patient group.
Further investigation is warranted based on promising safety and efficacy signals.