Phase II data come from the first randomized trial comparing immunotherapy outcomes after FMT with immunotherapy responders and placebo.
Fecal microbiota transplantation (FMT) may enhance the effectiveness of immunotherapy in advanced metastatic renal cell carcinoma (mRCC), according to a new study.
In Phase IIa TACITO trialthe first randomized trial comparing immunotherapy outcomes after FMT with immunotherapy responders and placebo, median progression-free survival was significantly longer in the donor-derived FMT group. A total of 45 patients with advanced kidney cancer participated in the study.
Co-principal investigator Professor Roberto Iacovelli added:[data showed] 24 months compared to 9 months in the control group. This corresponds to a 50% reduction in the risk of disease progression. ”
This is noteworthy given the evidence showing that immunotherapy does not seem to benefit the majority of patients.
Professor Giampaolo Tortola, full professor of medical oncology at the Sacro Católica University, explained: “The gut microbiota is known to influence the immune system, and in kidney cancer several factors, such as pronounced angiogenesis and inflammatory mediators such as IL-6, can reduce the effectiveness of immunotherapy.”
The study’s principal investigator, Dr. Gianluca Iannilo, added that the findings “provide further evidence that the gut microbiota is a key regulator of immunotherapy response…FMT from carefully selected donors may represent an important complementary strategy to improve outcomes in metastatic renal cell carcinoma, perhaps by providing immune stimulation that enhances therapeutic response.”
Leveraging FMT to improve immunotherapy outcomes in advanced cancer
FMT from carefully selected donors may represent an important complementary strategy to improve outcomes in metastatic renal cell carcinoma, perhaps by providing immune stimulation that enhances therapeutic responses. ”
Patients were initially treated with the standard first-line combination of the immune checkpoint inhibitor pembrolizumab and the antiangiogenic therapy axitinib and then randomized to receive either donor-derived FMT or a placebo.
This tested whether FMT from donors who achieved a complete response to immunotherapy could improve clinical outcomes in mRCC patients.
One-year data showed that 70% of patients in the donor-derived FMT group had no disease progression, compared with 41% in the placebo group, although this was not statistically significant. However, results for some secondary endpoints showed strong promise.
Another important finding showed that the objective response rate was higher (52 percent) in the donor-derived FMT group compared to 32 percent for placebo.
Dr. Chiara Chicarese, co-lead author of the study and oncology researcher at the University of Sacro Cuore, also said that this finding is particularly important for patients with intermediate or poor prognostic risk, “because these patients usually have fewer treatment options and worse outcomes.”
The study “Fecal microbiota transplantation versus pembrolizumab and axitinib in metastatic renal cell carcinoma: a randomized phase 2 TACITO trial” natural medicine.
Recent Phase II data Additionally, we are confirming the benefits of Merck’s anti-PD-1 therapy, particularly as a combination therapy. Pembrolizumab combined with Moderna’s mRNA-based endotismeran autogene (mRNA-4157 or V940) reduced the risk of disease recurrence or death in high-risk melanoma patients by 49 percent compared to Keytruda alone.