Researchers have found that fecal microbiota transplants from healthy donors may be safe and show potential in improving response rates to immunotherapy in patients with advanced melanoma, according to a phase I study published by Routy et al in Nature Medicine. Researchers administered about 40 oral fecal microbiota transplant capsules during a single session 1 week prior to the initiation of immunotherapy to 20 patients with melanoma.
They found that combining the fecal microbiota transplants with immunotherapy was potentially safe for the patients who participated in the study. They also discovered that 65% of the patients who retained the donors’ fecal microbiota had clinical responses to the combination treatment. However, 5 of them experienced adverse events sometimes associated with immunotherapy and had their treatment discontinued. The researchers are currently conducting a larger phase II trial and are also analyzing the potential of fecal microbiota transplants in the treatment of other cancer types—including renal cell carcinoma, pancreatic cancer, and lung cancer—as well as in patients with the human immunodeficiency virus and rheumatoid arthritis.