ESMO 2025 | Neoadjuvant nivolumab with or without visugromab in cisplatin-ineligible MIBC
Clara Steiner, MD, Dana-Farber Cancer Institute, Boston, MA & University Hospital Leipzig, Leipzig, Germany, presents the primary findings from the Phase II GDFather-NEO trial (NCT06059547), which evaluated neoadjuvant nivolumab with or without the GDF-15 inhibitor visugromab in cisplatin-ineligible patients with muscle-invasive bladder cancer. The dual-agent regimen achieved substantially higher pathological and radiologic response rates than nivolumab monotherapy, while maintaining a manageable safety profile. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
The Godfather NEO trial is a phase 2 trial presented by Dr. Necky. And the primary endpoints of the trial were looking at radiological and histopathological response to the combination of nivolumab plus visogromab compared to nivolumab alone. And both endpoints favored the combination arm of nivolumab and visogromab compared to nivolumab. The caveat here is that there were only few responses in the nivolumab monotherapy arm, and we have to be cautious with cross-trial comparisons...
The Godfather NEO trial is a phase 2 trial presented by Dr. Necky. And the primary endpoints of the trial were looking at radiological and histopathological response to the combination of nivolumab plus visogromab compared to nivolumab alone. And both endpoints favored the combination arm of nivolumab and visogromab compared to nivolumab. The caveat here is that there were only few responses in the nivolumab monotherapy arm, and we have to be cautious with cross-trial comparisons. But if we’re looking at other trials in this space, then there was only one pathological complete response to nivolumab, and this is comparatively low to other IO regimen that we’ve seen in this space.
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