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In this phase I study, 10 patients with anti–PD-1–refractory metastatic melanoma were treated with fecal microbiota transplantation (FMT) from 2 donors who had a complete response to immune checkpoint inhibitor (ICI) therapy. The combination of FMT and nivolumab resulted in 3 responses, including 1 complete response in a patient with no prior response to ICI treatment. FMT was associated with improvement in the nature of immune cell infiltrates and gene expression profiles in the gut and in the tumor.
Modulation of the gut microbiota may impact the response to cancer therapy.
The gut microbiome has been shown to influence the response of tumors to anti-PD-1 (programmed cell death-1) immunotherapy in preclinical mouse models and observational patient cohorts. However, modulation of gut microbiota in cancer patients has not been investigated in clinical trials. In this study, we performed a phase 1 clinical trial to assess the safety and feasibility of fecal microbiota transplantation (FMT) and reinduction of anti-PD-1 immunotherapy in 10 patients with anti-PD-1-refractory metastatic melanoma. We observed clinical responses in three patients, including two partial responses and one complete response. Notably, treatment with FMT was associated with favorable changes in immune cell infiltrates and gene expression profiles in both the gut lamina propria and the tumor microenvironment. These early findings have implications for modulating the gut microbiota in cancer treatment.
Fecal Microbiota Transplant Promotes Response in Immunotherapy-Refractory Melanoma Patients
Science 2021 Feb 05;371(6529)602-609, EN Baruch, I Youngster, G Ben-Betzalel, R Ortenberg, A Lahat, L Katz, K Adler, D Dick-Necula, S Raskin, N Bloch, D Rotin, L Anafi, C Avivi, J Melnichenko, Y Steinberg-Silman, R Mamtani, H Harati, N Asher, R Shapira-Frommer, T Brosh-Nissimov, Y Eshet, S Ben-Simon, O Ziv, MAW Khan, M Amit, NJ Ajami, I Barshack, J Schachter, JA Wargo, O Koren, G Markel, B Boursi