CatalYm Presents Phase 2 Data Showing Visugromab Substantially Enhances the Clinical Benefit of PD-1 Inhibition in Neoadjuvant Bladder Cancer at ESMO 2026
Visugromab combined with PD-1 inhibitor nivolumab demonstrated higher response rates versus nivolumab alone across primary and secondary endpoints: pathologic Complete Response (pCR; 33% vs. 8%), radiographic Objective Response Rate (ORR; 60% vs. 15%) and Major Pathologic Response (MPR; 60% vs. 23%)
Enhanced responses were associated with increased eligibility for bladder-sparing treatment approaches in cisplatin-ineligible or cisplatin-refusing patients with muscle-invasive bladder cancer (MIBC)
Independent central assessment was largely concordant with the locally assessed pathologic and radiographic response results, reinforcing the robustness of the observed benefit in the visugromab treatment arm
Visugromab combination was overall well tolerated, with no treatment-related discontinuations and no new safety signals
Results were simultaneously published in Nature Medicine and support the ongoing late-stage clinical development of visugromab in early treatment lines for high-need solid tumor indications, including checkpoint-inhibitor-naïve cancers
MUNICH & SAN FRANCISCO, October 24, 2026--CatalYm today announced final results from its randomized Phase 2 GDFATHER-NEO trial, which were presented in a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 and simultaneously published in Nature Medicine. The data showed that Growth Differentiation Factor-15 (GDF-15) blockade with visugromab substantially enhanced the anti-tumor activity of the PD‑1 inhibitor nivolumab in the neoadjuvant treatment of patients with newly diagnosed, checkpoint-inhibitor-naïve muscle-invasive bladder cancer (MIBC). Visugromab is a humanized monoclonal antibody designed to neutralize the tumor-derived cytokine GDF-15, a key mediator of immune suppression and resistance to anti-PD-(L)1 therapies.
"With more than one year of follow-up and support from independent central assessment, these final results further strengthen the clinical evidence for visugromab and extend its potential into another high-need solid tumor indication," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "The improvements observed across key endpoints highlight the potential of visugromab to add meaningful benefit to PD-1 inhibition already in earlier treatment lines, providing further support for our ongoing Phase 2b programs in first- and second-line lung and liver cancer settings with high medical need."
The Nature Medicine article, titled "Neoadjuvant nivolumab with visugromab versus placebo in patients with muscle-invasive bladder cancer: the GDFATHER-NEO phase 2 trial," reports the final results from the study. Both the publication and the ESMO presentation highlight the efficacy benefits observed with the addition of visugromab to nivolumab in the neoadjuvant setting, including improvements in pathologic Complete Response (pCR), Major Pathological Response (MPR) and radiographic Objective Response Rate (ORR), while maintaining an overall well-tolerated safety profile comparable to nivolumab alone. Importantly, independent central assessment of the study endpoints was largely concordant with the locally assessed results, reinforcing the robustness of the overall treatment benefit observed in the visugromab combination arm.