Results from a Phase 2 clinical trial for patients with advanced uveal melanoma were presented at ESMO 2024 on September 15, 2024. Among patients with metastatic uveal melanoma, 80% have liver metastasis. There are insufficient treatment options for this patient population.

The clinical trial, GEM 2101, was designed to assess the treatment-related side effects and efficacy of combining the investigational agents, sitravatinib and tislelizumab.

Patients (n=16) enrolled in GEM 2101 had metastatic uveal melanoma with liver metastasis. In addition, these patients either had no prior treatment or failed to respond to treatment with tebentafusp (Kimmtrak).

Efficacy results presented at ESMO showed an overall response rate of 18.8% with three patients meeting the criteria for substantial liver tumor shrinkage. The median duration of treatment was 6.6 months, with a range of 3.5 – 12.2 months, and the median follow-up was 6.9 months.

Sitravatinib is an oral agent that targets signaling proteins inside cells, including proteins in the vascular endothelial growth factor receptor family, platelet-derived growth factor receptor family, and others. Tislelizumab is immunotherapy that is administered intravenously and to block the immune system checkpoint PD1 and re-energize the immune system to recognize the tumor.

Half of the patients reported treatment-related side effects that were mildly concerning and required dose adjustments. The most common side effects reported overall included hypertension (25%) and diarrhea (18.8%). The investigational treatment was stopped in three patients due to toxicity.

The data collected in the study are undergoing further research to understand more about from these investigational agents using blood samples and liver biopsies.

This report was created from the ESMO presentation on metastatic uveal melanoma presented on September 15, 2024 in Barcelona by Dr. del Carpio Huerta.