What's Happening?
CatalYm has presented Phase 2 data from the GDFATHER-NEO trial at the European Society of Medical Oncology (ESMO) Congress, demonstrating 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 increased major pathologic response rates compared to nivolumab alone. The trial showed a fourfold increase in radiologic objective response rate, with good tolerability and safety profiles. Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a cytokine that suppresses immune response and contributes to treatment resistance.
Why It's Important?
The promising results from the GDFATHER-NEO trial suggest that visugromab could become a new treatment option for patients with muscle-invasive bladder cancer, 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 offer a less toxic alternative to existing therapies. This development is significant for the oncology field, as it addresses the unmet need for effective treatments in bladder cancer, potentially influencing future therapeutic strategies and clinical practices.
What's Next?
CatalYm plans to continue the Phase 2 GDFATHER-NEO trial with further biomarker analysis and safety assessments. The company is also advancing a broad Phase 2b clinical program with randomized trials in non-small cell lung cancer, hepatocellular carcinoma, and cachexia. These efforts aim to expand the application of visugromab across various cancer types, potentially leading to new treatment regimens and improved patient outcomes.
