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Cancer

Visugromab Demonstrates Durable Responses in Advanced Solid Tumors and Cachexia

Strategic Insights

— 2 min read

CatalYm, a world leader in neutralizing GDF-15 in cancer and cachexia, presented updated long-term data from its ongoing GDFATHER-1/2a trial at the European Society of Medical Oncology (ESMO) Congress 2025. The data provide further evidence that Growth Differentiation Factor-15 (GDF-15) blockade by visugromab can reverse resistance to PD-(L)1 treatment in patients with advanced solid tumors and deliver durable responses in patients who have relapsed or progressed on prior checkpoint inhibitor treatment. The updated dataset highlights visugromab's potential to reinvigorate immune responses in difficult-to-treat tumor types and patient populations with limited treatment alternatives.

Key Takeaways:

  • The median duration of response reached 32.2 months in non-squamous non-small cell lung cancer (nsqNSCLC), 28.8 months in urothelial cancer (UC), and 19.4 months in hepatocellular carcinoma (HCC), with more than half of responses ongoing at the data cut-off.
  • A majority of responders experienced deeper and longer-lasting responses when compared to prior anti-PD-1/PD-(L)1 treatment.
  • GDF-15 blockade re-sensitized tumors to immunotherapy and demonstrated favorable safety and tolerability in heavily pretreated patients.
  • Visugromab mitigated cachexia in affected patients, supporting dual benefit in tumor control and weight gain.
  • The combination of visugromab and nivolumab was well-tolerated, with treatment-related adverse events (TRAEs) reported in 58.4% of patients, most of which were Grade 1 or 2 and manageable.
  • Clinically meaningful weight gain was observed in cachectic patients, suggesting potential quality-of-life benefits.
  • The growing body of clinical data for visugromab confirms the company's conviction that GDF-15 neutralization provides a novel strategy to overcome immune resistance and support immune reactivation.

Statistics:

  • 77 patients with either non-squamous NSCLC (n=22), urothelial cancer (n=27), or hepatocellular carcinoma (n=28) received visugromab in combination with nivolumab, all with progression on prior anti-PD-(L)1 therapy.
  • Confirmed objective response rates (RECIST 1.1) were 18.2% (4/22) in non-squamous NSCLC, 18.5% (5/27) in urothelial cancer, and 14.3% (4/28) in hepatocellular carcinoma.
  • 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.
  • At data cut-off, 53.8% (7 of 13) of responses were ongoing across all three cohorts.
  • In 76.9% (10/13) of responders, the duration of response on visugromab plus nivolumab exceeded that of their prior checkpoint inhibitor treatment; 61.5% of responders also achieved a deeper response than previously recorded.

Sources:

  • CatalYm press release, "CatalYm Announces Long-Term Data from GDFATHER-1/2a Trial of Visugromab in Combination with Nivolumab to Be Presented at ESMO 2025", October 20, 2025
  • Nature publication, "Visugromab Demonstrates Durable Anti-Tumor Efficacy in Relapsed and Refractory Metastatic Solid Tumor Patients"
  • International Conference on Sarcopenia, Cachexia & Wasting Disorders, "Visugromab Can Significantly Counteract the Effects of Cachexia in Patients with Advanced Cancer"
  • Businesswire.com, "CatalYm Announces Long-Term Data from GDFATHER-1/2a Trial of Visugromab in Combination with Nivolumab to Be Presented at ESMO 2025"

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