Overview
- Three studies published in Nature Medicine report improved outcomes when fecal microbiota transplantation is added to checkpoint inhibitors in kidney, lung and melanoma cancers.
- In the randomized Phase II TACITO trial for metastatic renal cell carcinoma, adding responder‑donor FMT to pembrolizumab plus axitinib extended median progression‑free survival to 24 months from 9 months and raised objective response rates to 52% from 32%, though the 12‑month progression‑free primary endpoint was not statistically met.
- The PERFORM Phase I study in metastatic kidney cancer found roughly a 50% objective response rate using capsule FMT from healthy donors with ipilimumab plus nivolumab, including two complete responses and fewer immune‑related side effects among responders.
- The Phase II FMT‑LUMINate trial reported tumor shrinkage in 80% of non‑small cell lung cancer patients and 75% of melanoma patients after a single FMT capsule course followed by standard immunotherapy, with frequent serious toxicities in melanoma linked to Prevotella‑rich donors.
- Microbiome profiling confirmed donor strain engraftment and greater diversity, and investigators tied benefit to specific bacterial taxa and the removal of harmful strains while emphasizing stringent donor screening and the need for larger, standardized trials.