What's Happening?
CatalYm has presented updated long-term data from its GDFATHER-1/2a trial at the European Society of Medical Oncology (ESMO) Congress 2025. The trial evaluates visugromab, a monoclonal antibody designed to neutralize Growth Differentiation Factor-15 (GDF-15),
in combination with an anti-PD-1 inhibitor for patients with advanced solid tumors. The data shows that visugromab can reverse resistance to PD-(L)1 treatment and deliver durable responses in patients who have relapsed or progressed on prior checkpoint inhibitor treatment. The trial involved 199 patients, with confirmed objective response rates of 18.2% in non-squamous NSCLC, 18.5% in urothelial cancer, and 14.3% in hepatocellular carcinoma. The median duration of response reached 32.2 months in non-squamous NSCLC, 28.8 months in urothelial cancer, and 19.4 months in hepatocellular carcinoma.
Why It's Important?
The findings from CatalYm's trial are significant as they offer a potential new treatment strategy for patients with advanced solid tumors who have limited options after progressing on prior immunotherapy. Visugromab's ability to reinvigorate immune responses in difficult-to-treat tumor types could lead to improved outcomes for these patients. The trial results also suggest that visugromab may provide a dual benefit by mitigating cancer cachexia, a severe condition affecting many advanced cancer patients. This could enhance the quality of life for patients by supporting weight gain and tumor control. The data underscores the potential of GDF-15 blockade to establish immune sensitivity in resistant tumors, which could be pivotal in developing new cancer therapies.
What's Next?
CatalYm is advancing visugromab into multiple Phase 2b studies, including first-line metastatic NSCLC and cachexia. The company aims to translate the approach of GDF-15 neutralization into improved outcomes across different patient populations and tumor types. With several Phase 2b trials underway, CatalYm is focused on further developing visugromab in earlier treatment lines where maintaining immune sensitivity is critical. The ongoing research and trials could lead to new therapeutic options for cancer patients, potentially changing the landscape of cancer treatment.
Beyond the Headlines
The development of visugromab highlights the importance of targeting specific immunosuppressive factors like GDF-15 in cancer treatment. This approach not only addresses tumor resistance but also tackles cachexia, a condition that significantly impacts patient health and quality of life. The success of visugromab could pave the way for similar strategies in other types of cancer, emphasizing the need for personalized medicine that considers both tumor biology and patient well-being.
