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FMT plus immunotherapy showed clinical activity in NSCLC and melanoma

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Research area:medicine-clinical

What the study found

The study found that fecal microbiota transplantation, or FMT, given before immunotherapy was active in two cancer groups: non-small cell lung cancer and melanoma. The authors also report that the gut microbiome changes seen in responders were linked to loss of certain baseline bacterial species.

Why the authors say this matters

The authors conclude that these findings confirm the clinical activity of FMT combined with immune checkpoint inhibitors, which are treatments that help the immune system attack cancer. They also suggest that eliminating harmful bacterial species may be required for FMT to provide therapeutic benefit.

What the researchers tested

This was a multicenter, open-label, phase 2 trial called FMT-LUMINate. Healthy donor FMT was given as oral capsules before first-line immunotherapy in 20 patients with non-small cell lung cancer and 20 patients with melanoma; the primary endpoint was objective response rate in non-small cell lung cancer, with secondary endpoints including melanoma response, safety, and donor-host microbiome similarity.

What worked and what didn't

In non-small cell lung cancer, the objective response rate was 80% (16 of 20 patients), meeting the study's primary endpoint. In melanoma, the objective response rate was 75% (15 of 20 patients), and the independent committee deemed FMT safe in both groups; there were no grade 3 or higher adverse events in non-small cell lung cancer, while 13 melanoma patients had grade 3 or higher adverse events.

What to keep in mind

The abstract does not describe a control group, so the findings are based on a single-arm phase 2 trial. The microbiome findings were reported from sequencing analyses and mouse experiments, and the abstract does not provide longer-term outcomes or detailed limitations beyond the stated trial design.

Key points

  • FMT given before immunotherapy produced an 80% objective response rate in non-small cell lung cancer.
  • Melanoma patients had a 75% objective response rate after FMT plus dual immune checkpoint blockade.
  • The trial was multicenter, open-label, and phase 2, with 20 patients in each cancer cohort.
  • Responders showed a distinct post-FMT gut microbiome composition and greater loss of some baseline bacterial species.
  • The authors report that reintroducing those lost bacterial species into mice removed the antitumor effect of immunotherapy.

Disclosure

Research title:
FMT plus immunotherapy showed clinical activity in NSCLC and melanoma
Authors:
Sreya Duttagupta, Meriem Messaoudene, Sebastian Hunter, Antoine Desîlets, Rahima Jamal, Catalin Mihalcioiu, Wiam Belkaïd, Nicolas Marcoux, Marine Fidelle, Déborah Suissa, Mayra Ponce, Mallia Geiger, Julie Malo, Gianmarco Piccinno, Michal Punčochář, Alysé Filin, Vitor Heidrich, Diana Rusu, Babacar Mbaye, Sylvère Durand, I. Ben Aissa, Vadim Puller, Raynald de Lahondès, Normand Blais, Mustapha Tehfé, Scott Owen, Karl Bélanger, Seema Nair Parvathy, Benjamin Shieh, Jacques Raphael, John Gordon Lenehan, Daniel Breadner, J. Rothenstein, Nicholas Rozza, Jade Maillou, Somayeh Nili, Diogjena Katerina Prifti, Federica Pinto, Federica Armanini, Seunghee Kim‐Schulze, Thomas U. Marron, G. Kroemer, Lisa Derosa, Laurence Zitvogel, Michael S. Silverman, Nicola Segata, Saman Maleki Vareki, Bertrand Routy, Arielle Elkrief
Institutions:
Analyse moléculaire, modélisation et imagerie de la maladie cancéreuse, Analyse moléculaire, modélisation et imagerie de la maladie cancéreuse, Assistance Publique – Hôpitaux de Paris, Centre de Recherche des Cordeliers, Centre de Recherche des Cordeliers, Centre hospitalier de l'Université Laval, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre Hospitalier de l’Université de Montréal, Centre hospitalier universitaire de Québec, Centre National de la Recherche Scientifique, Centre National de la Recherche Scientifique, Hôpital Européen, Hôpital Européen Georges-Pompidou, Icahn School of Medicine at Mount Sinai, Icahn School of Medicine at Mount Sinai, Inserm, Inserm, Inserm, Inserm, Inserm, Inserm, Institut Gustave Roussy, Institut Gustave Roussy, Institut Gustave Roussy, Institut Gustave Roussy, Institut Gustave Roussy, Institut Gustave Roussy, Institute of Cancer Research, La Ligue Contre le Cancer, La Ligue Contre le Cancer, La Ligue Contre le Cancer, La Ligue Contre le Cancer, Lakeridge Health, Lawson Health Research Institute, Lawson Health Research Institute, London Health Sciences Centre, London Health Sciences Centre, London Health Sciences Centre, London Health Sciences Centre, McGill University, McGill University, McGill University, McGill University, Occupational Cancer Research Centre, Occupational Cancer Research Centre, Occupational Cancer Research Centre, Occupational Cancer Research Centre, Ontario Institute for Cancer Research, Sorbonne Université, St Joseph's Health Care, St Joseph's Health Care, Université de Montréal, Université de Montréal, Université de Rouen Normandie, Université de Rouen Normandie, Université Paris Cité, Université Paris-Saclay, Université Paris-Saclay, Université Paris-Saclay, Université Paris-Saclay, Université Paris-Saclay, Université Paris-Saclay, University of Trento, University of Trento, University of Trento, University of Trento, University of Trento, University of Trento, Western University, Western University, Western University, Western University, Western University, Western University
Publication date:
2026-01-28
DOI:
10.1038/s41591-025-04186-5
OpenAlex record:
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AI provenance: This post was generated by gpt-5.4-mini (OpenAI). The original authors did not write or review this post.

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