ESMO 2026 | GDFather-NEO: 2026 updates of nivolumab with or without visugromab in MIBC
Andrea Necchi, MD, IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy, comments on final pathological and radiological outcomes and initial event-free survival data from the Phase II GDFather-NEO trial (NCT06059547), which evaluated nivolumab with or without the GDF-15-neutralizing antibody visugromab in muscle-invasive bladder cancer (MIBC). Addition of visugromab enhanced pathological and radiological responses, with early evidence of event-free survival benefit, including in a bladder-preserving subset. No new safety signals emerged, supporting further investigation and GDF-15 as a therapeutic target. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.
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Transcript
Yeah, it was a nice story. So the GDFather-NEO trial brought the nivolumab and visugromab combination neoadjuvantly after the results that have been published recently with the use of the same combination in the advanced setting. The target is GDF15, which is an interesting target that was found by a German gynecologist as being highly expressed by placenta, as being an immune suppressive factor...
Yeah, it was a nice story. So the GDFather-NEO trial brought the nivolumab and visugromab combination neoadjuvantly after the results that have been published recently with the use of the same combination in the advanced setting. The target is GDF15, which is an interesting target that was found by a German gynecologist as being highly expressed by placenta, as being an immune suppressive factor. And then it was realized that it was highly expressed in most tumor types, including urothelial cancer. Phase one trial in immunotherapy refractory tumors, including urothelial cancer, with a combination of nivo and visugromab which is the antibody neutralizing GDF15 provided on almost 20% response rate and then we jump to the neoadjuvant setting with with them with the stratified the location of patients 15 and 15 patients to receive nivolumab and visugromab for cycles before cystectomy or RIT-URBT, so a bladder sparing opportunity depending on response or nivolumab and placebo and the same cystectomy or RIT-URBT. The main outcomes, the main endpoint, the primary endpoint was the pathological complete response rate and we presented the update of the PCR rates in the two arms. The PCR rate with NIVO and VISU combination was 33%, 60% the major response rate, four-fold higher than nivolumab and placebo. And we initially presented here, this year, the initial EFS outcomes showing that no relapses occurred with the median follow-up of 15 months in those who got PCR. There was only one tumor relapse in those who had the major response after Nivo and Viso, consisting of a superficial high-grade relapse. Safety was quite good, no new safety signal and there was a confirmation that baseline immune cell infiltration CD8 and proliferating CD8 infiltration was associated with benefit with Nivolumab and Visuglumab in particular. So overall this trial could be informative in the way we could conceive an additional player in the game of new adjuvant therapies maybe for next association maybe with ev pembrol or similar or similar companion drugs
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