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TACITO: Does faecal microbiota transplantation improve survival in mRCC?

Presented by
Dr Gianluca Ianiro, Agostino Gemelli University Policlinic, Italy
Conference
UEGW 2024
Trial
Phase 2, TACITO
Doi
https://doi.org/10.55788/24c2ed5f
Participants with metastatic renal cell carcinoma (mRCC) may experience an additional benefit from targeted faecal microbiota transplantation (FMT) on top of their regimen of pembrolizumab plus axitinib, according to the results of the phase 2 TACITO trial.

The microbiome has previously been associated with an enhanced response to immune checkpoint inhibitors in epithelial cancers [1,2]. A study including 10 patients with refractory melanoma and treated with immune checkpoint inhibitors showed that FMT may improve the clinical response of these patients [3]. Another study among 16 patients with refractory melanoma displayed similar results [4]. “Moreover, there is evidence that FMT may improve the response to immune checkpoint inhibitors among newly diagnosed patients with melanoma,” according to Dr Gianluca Ianiro (Agostino Gemelli University Policlinic, Italy) [5]. “However, all this evidence comes from studies that are not randomised-controlled trials.”

Dr Ianiro and colleagues designed the randomised-controlled TACITO trial (NCT04758507) to compare FMT with a placebo among 50 participants with mRCC already receiving pembrolizumab plus axitinib [6]. The primary endpoint was progression-free survival (PFS) at 1 year post-randomisation “We used single donors and no antibiotic pre-treatment,” added Dr Ianiro.

The 1-year PFS rates were 66.7% and 35%, significantly favouring the active arm over the placebo arm (P=0.036). “We did not see a difference in PFS at 2 years of follow-up,” mentioned Dr Ianiro. “The significant difference during the active period of the trial matches very well with the biological data we have on FMT.” The preliminary data on overall survival also suggests a benefit for the FMT group over the placebo group (5/25 deceased vs 10/25). The overall response rates also favour the FMT arm (52% vs 28%). Finally, the authors did not see any adverse events related to FMT.

In summary, these findings indicate that FMT may increase the efficacy of immune checkpoint inhibitor plus VEGF tyrosine kinase inhibitor combination therapy in patients with mRCC.


    1. Routy B, et al. Science. 2018;359(6371):91-97.
    2. Gopalakrishnan V, et al. Science. 2018;359(6371):97-103.
    3. Baruch EN, et al. Science. 2021;371(6529):602-609.
    4. Davar D, et al. Science. 2021;371(6529):595-602.
    5. Routy B, et al. Nat Medicine. 2023;29(8):2121-2132.
    6. Porcari S, et al. Targeted fecal microbiota transplantation in patients receiving pembrolizumab plus axitinib for metastatic renal cell carcinoma: preliminary results from a randomized, double-blind placebo-controlled trial (TACITO trial). LB01, UEG Week 2024, 12–15 October, Vienna, Austria.

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