Andrea Necchi, MD, highlights data on neoadjuvant nivolumab plus visugromab in MIBC

Primary results from the phase 2 GDFather-NEO trial (NCT06059547) were presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany.¹ Overall, the trial explored the combination of nivolumab plus the GDF-15 neutralizing antibody visugromab vs nivolumab monotherapy as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC).

Presenting author Andrea Necchi, MD, joined Urology Times® to share the key findings from the study. Necchi is an associate professor of oncology at Vita-Salute San Raffaele University in Milan, Italy, and Director of GU Medical Oncology at San Raffaele Hospital.

Overall, data showed a pathologic complete response rate of 33.3% in the nivolumab/visugromab arm vs 7.7% in the nivolumab monotherapy arm. The rate of major pathologic response was 66.7% in the combination arm vs 23.1% in the monotherapy arm. Objective response rates were 60% vs 15.4%, respectively.

According to Necchi, “The baseline biomarker characteristics in terms of pre-existing immune infiltration in tumor microenvironment, GDF15 expression, circulating GDF15 levels, or circulating cytokine level that are associated with the immune response were pretty well-distributed between arms. So, [there was] nothing that would justify such disconnection in terms of efficacy according to the baseline biomarker monitor characteristics, baseline clinical and tumor characteristics, and so on.”

Necchi also noted that the combination was well-tolerated, with no grade 4 adverse events reported.

REFERENCE

1. Necchi A, Mercinelli C, Maiorana BA, et al. A blinded, exploratory phase II trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFather-NEO trial. Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA110