1. Immunotherapy in MSI/dMMR tumors in the perioperative setting: The IMHOTEP trial.
- Author
-
Coutzac, Clélia, Bibeau, Frederic, Ben Abdelghani, Meher, Aparicio, Thomas, Cohen, Romain, Coquan, Elodie, Dubreuil, Olivier, Evesque, Ludovic, Ghiringhelli, François, Kim, Stefano, Lesourd, Samuel, Neuzillet, Cindy, Phelip, Jean-Marc, Piessen, Guillaume, Rochigneux, Philippe, Samalin, Emmanuelle, Soularue, Emilie, Touchefeu, Yann, Tougeron, David, and Zaanan, Aziz
- Abstract
Immune checkpoint inhibitors (ICI) targeting Programmed death-1 (PD-1) have shown their efficacy in advanced MSI/dMMR (microsatellite instability/deficient mismatch repair) tumors. The MSI/dMMR status predicts clinical response to ICI. The promising results evaluating ICI in localized MSI/dMMR tumors in neoadjuvant setting need to be confirmed in MSI/dMMR solid tumors. The aim of the IMHOTEP trial is to assess the efficacy of neoadjuvant anti-PD-1 treatment in MSI/dMMR tumors regarding the pathological complete response rate. This study is a prospective, multicenter, phase II study including 120 patients with localized MSI/dMMR carcinomas suitable for curative surgery. A single dose of pembrolizumab will be administered before the surgery planned 6 weeks later. Primary objective is to evaluate the efficacy of neoadjuvant pembrolizumab according to pathological complete tumor response. Secondary objectives are to assess safety, recurrence-free survival and overall survival. Ancillary studies will assess molecular and immunological biomarkers predicting response/resistance to ICI. First patient was enrolled in December 2021. The IMHOTEP trial will be one of the first clinical trial investigating perioperative ICI in localized MSI/dMMR in a tumor agnostic setting. Assessing neoadjuvant anti-PD-1 is mandatory to improve MSI/dMMR patient's outcomes. The translational program will explore potential biomarker to improve our understanding of immune escape and response in this ICI neoadjuvant setting. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF