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FMT with immunotherapy showed activity in NSCLC and melanoma

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Research area:OncologyCancer Immunotherapy and BiomarkersLung cancer

What the study found

Fecal microbiota transplantation (FMT, transfer of gut microbes from a healthy donor) combined with immune checkpoint inhibitor treatment showed clinical activity in first-line non-small cell lung cancer (NSCLC) and melanoma. The study also found that responders developed a distinct gut microbiome after FMT, and that loss of certain baseline bacterial species was associated with response.

Why the authors say this matters

The authors conclude that these findings confirm clinical activity of FMT with immune checkpoint inhibitors (drugs that help the immune system attack cancer) and suggest that eliminating harmful bacterial species may be required for FMT-mediated benefit.

What the researchers tested

This was a multicenter, open-label, phase 2 trial called FMT-LUMINate. It included 20 patients with NSCLC who received healthy donor FMT plus anti-PD-1 therapy, and 20 patients with melanoma who received FMT plus dual immune checkpoint therapy with anti-PD-1 and anti-CTLA-4, all in the first-line setting.

What worked and what didn't

In NSCLC, the objective response rate was 80% (16 of 20), meeting the study's primary endpoint. In melanoma, the objective response rate was 75% (15 of 20). FMT was judged safe by an independent monitoring committee; no grade 3 or higher adverse events were reported in NSCLC, while 13 melanoma patients (65%) had grade 3 or higher adverse events.

What to keep in mind

The abstract does not describe a control group, so comparisons beyond these trial results are not provided here. The microbiome findings and mouse experiments are reported as supporting evidence, but the abstract gives limited detail on how they translate beyond the study setting.

Key points

In first-line NSCLC, FMT plus anti-PD-1 therapy had an objective response rate of 80% (16/20).
In melanoma, FMT plus anti-PD-1 plus anti-CTLA-4 therapy had an objective response rate of 75% (15/20).
Responders developed a distinct post-FMT gut microbiome, and they showed greater loss of baseline bacterial species than non-responders.
The abstract reports no grade 3 or higher adverse events in the NSCLC cohort, but 65% of melanoma patients had grade 3 or higher adverse events.
Mouse experiments suggested that reintroducing specific bacteria lost after FMT removed the antitumor effect of immune checkpoint therapy.

Disclosure

Research title:: FMT with immunotherapy showed activity in NSCLC and melanoma
Publication date:: 2026-01-28
DOI:: 10.1038/s41591-025-04186-5
OpenAlex record:: View
Image credit:: Photo by Maksim Goncharenok on Pexels

AI provenance: AI provenance information is not available for this post.