TACITO: Does FMT improve ICI plus VEGFR TKI therapy in mRCC?

Patients with metastatic renal cell carcinoma (mRCC) appeared to experience an additional benefit from targeted faecal microbiota transplantation (FMT) on top of their regimen of pembrolizumab plus axitinib, in the phase 2 TACITO trial.

Dr Gianluca Ianiro (Agostino Gemelli University Policlinic, Italy) and colleagues designed the randomised-controlled TACITO trial (NCT04758507) to compare FMT with placebo among 50 patients with mRCC already receiving pembrolizumab plus axitinib [1]. The primary endpoint was the rate of participants free of progression after 1 year from randomisation. “We used single donors and no antibiotic pre-treatment,” added Dr Ianiro.

The 1-year progression-free survival (PFS) rates were 66.7% and 35.0%, 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.” Although the overall survival data was not yet mature, the preliminary data suggests a benefit for the FMT group over the placebo group (5/25 deceased vs 10/25). The overall response rates were also in favour of the FMT arm (52% vs 28%). Finally, the authors did not see any adverse events related to FMT.

In summary, this data indicates that FMT may increase the efficacy of immune checkpoint inhibitor (ICI) plus VEGF tyrosine kinase inhibitor (TKI) combination therapy in patients with mRCC.

1. 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). Abstract LB01, UEG Week 2024, 12–15 October, Vienna, Austria.

Medical writing support was provided by Robert van den Heuvel.

Copyright ©2024 Medicom Medical Publishers



Posted on 15 October 202415 October 2024