Faecal microbiota transplantation for PD-1 non-responders
Transplanting gut bacteria from patients who responded to immunotherapy into those who did not. In small studies a minority of resistant melanomas started responding. Randomised trials are running.
Two single-arm phase 1 studies published together in Science in 2021 (Pittsburgh, NCT03341143; Sheba, NCT03353402) gave responder-derived faecal microbiota transplantation (FMT) plus anti-PD-1 to patients with anti-PD-1-refractory melanoma: 6 of 15 and 3 of 10 patients had clinical benefit, with increased CD8 infiltration and engraftment of donor taxa. In the first-line setting, MIMic-01 (Montreal, NCT03772899, Nature Medicine 2023) combined healthy-donor FMT with anti-PD-1 in 20 patients and reported a 65% objective response rate, above historical controls. Randomised phase 2 trials are now running in Canada, Norway and the Netherlands using capsule FMT, and defined bacterial consortia and single-strain products (for example, CBM588, Akkermansia) are in development as a more controllable alternative. Donor screening, transmission risk and lack of a validated 'good microbiome' signature remain the problems.
How it works
Replacing a non-permissive gut community with a responder-derived one restores microbial signals (metabolites, pattern-recognition ligands) that prime dendritic cells and systemic anti-tumour T-cell immunity.
- Responses in genuinely refractory patients
- Agnostic to tumour genotype
- Cheap relative to drugs
- Single-arm studies, small numbers
- Donor variability and safety (screening for pathogens)
- Antibiotics, diet and proton-pump inhibitors confound everything
Latest papers
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