What's Happening?
CatalYm has presented Phase 2 data from the GDFATHER-NEO trial at the ESMO Congress 2025, showing that visugromab, combined with the PD-1 inhibitor nivolumab, significantly enhances anti-tumor activity in muscle-invasive bladder cancer (MIBC). The combination
therapy more than quadrupled the rate of pathological complete response and substantially increased major pathologic response rates compared to nivolumab alone. Visugromab is designed to neutralize the tumor-derived cytokine GDF-15, which plays a central role in immune suppression and treatment resistance.
Why It's Important?
The data suggests that visugromab could offer a new treatment option for MIBC patients, particularly those ineligible for standard chemotherapy due to age or comorbidities. The enhanced anti-tumor activity and favorable safety profile of the visugromab combination could improve patient outcomes and provide a less toxic alternative to existing therapies. This development is significant given the poor survival rates associated with MIBC and the limited efficacy of current treatment regimens.
What's Next?
CatalYm is advancing its Phase 2b clinical program, including trials in non-small cell lung cancer and hepatocellular carcinoma. The ongoing GDFATHER-NEO trial will continue with biomarker analysis and final safety assessments. The promising results could lead to further studies and potential regulatory approval, expanding treatment options for cancer patients.
