Overview
- In the randomized Phase II TACITO trial for metastatic renal cell carcinoma, donor FMT added to pembrolizumab plus axitinib led to 70% progression‑free at 12 months versus 41% with placebo, with median PFS of 24 months versus 9 months and a higher objective response rate, though the primary endpoint was not statistically significant.
- PERFORM, a Phase I kidney‑cancer study, reported about 50% objective responses with FMT plus ipilimumab and nivolumab and observed reduced immune‑related toxicities that may help patients remain on treatment.
- The Phase II FMT‑LUMINate trial found tumor shrinkage in 80% of lung cancer patients and 75% of melanoma patients, with frequent serious adverse events in the melanoma cohort receiving ipilimumab plus nivolumab linked to Prevotella‑rich donor microbiomes.
- Microbiome analyses confirmed donor strain engraftment and increased diversity, with clinical benefit associated with specific taxa such as introduction of Blautia wexlerae and reduction of harmful strains rather than overall engraftment alone.
- Across studies, donor material underwent extensive screening and was delivered via manufactured capsules such as LND101, and investigators called for larger randomized trials, predictive biomarkers, and potential defined microbial consortia.