KEY TAKEAWAYS
- The phase I trial aimed to test the idea that FMT can be used as the first-line treatment for IMC to improve symptoms and reduce the need for steroids, which can have side effects.
- Interim data from a clinical trial of front-line FMT for IMC in pts with grade ≥ 2 symptoms and no prior immunosuppressive treatment.
- The study found that FMT was a safe and effective first-line IMC treatment that can help pts avoid steroids and resume immunotherapy.
Fecal Microbiota Transplantation (FMT) is a new treatment that could help patients(pts) with moderate to severe immune-mediated colitis(IMC) avoid long-term immunosuppression and its side effects. This study will test whether FMT can be used as a first-line treatment for IMC to improve symptoms and reduce the need for steroids.
Researchers aimed to test the idea that FMT can be used as the first-line treatment for IMC to improve symptoms and reduce the need for steroids, which can have side effects.
The study presented preliminary results from a clinical trial assessing FMT as a first-line treatment for immune-mediated colitis. Eligible pts had to exhibit grade ≥ 2 immune-related diarrhea or colitis symptoms within 45 days of FMT. They must not have received any immunosuppressive treatments for IMC or other conditions around the time of FMT.
About 7 pts have participated in the trial. They received initial FMT treatment within a median of 35 days (IQR: 18-57 days) after the onset of IMC. Encouragingly, 71.4% of pts experienced symptom improvement within a median of 1 day (IQR: 1-5 days) after FMT. The sole adverse events(AEs) associated with FMT were temporary fever and self-resolving abdominal cramping in three pts (42.8%) during the first week. All pts had to discontinue immunotherapy due to IMC, but after FMT, 85.7% were able to resume their cancer treatments, with 57.1% resuming immunotherapy. By the end of the study period, 57.1% of pts achieved colitis remission, and 1 patient showed symptom improvement but passed away before the outcome of IMC could be assessed.
The study found that FMT is a safe and effective first-line treatment for IMC that can help patients avoid steroids and resume immunotherapy.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.2510
Clinical Trial: https://www.clinicaltrials.gov/study/NCT04038619
Yinghong Wang, Krishnavathana Varatharajalu, Malek Shatila, Matthew T Campbell, Pavlos Msaouel, and Craig A. Kovitz. DOI: 10.1200/JCO.2023.41.16_suppl.2510 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 2510-2510.
