Cabozantinib Plus Temozolomide Shows Clinical Activity in Advanced Soft Tissue Sarcomas
Key Clinical Summary:
- Design/Population: This multicenter, single-arm, phase 2 trial evaluates cabozantinib plus temozolomide in patients with unresectable or metastatic leiomyosarcoma and other soft tissue sarcomas who had received prior systemic therapy.
- Key Outcomes: The combination demonstrated clear signals of antitumor activity with durable disease control in a subset of patients and a manageable safety profile consistent with the known effects of both agents.
- Clinical Relevance: These findings support cabozantinib plus temozolomide as a promising therapeutic strategy in advanced leiomyosarcoma and reinforce the potential of biologically rational combination approaches in a disease with limited effective options beyond first-line therapy.
Varun Monga, MBBS, University of California San Francisco, San Francisco, California, discusses results from a single-arm, phase 2 trial evaluating cabozantinib plus temozolomide in patients with unresectable or metastatic leiomyosarcoma and other soft tissue sarcomas.
The study demonstrated clinically meaningful disease control in cohort 1, with manageable toxicity and no treatment-related deaths. These findings support further investigation of rational combination strategies in advanced sarcoma.
Source:
Monga V, Okuno S, Van Tine B, et al. Cabozantinib and temozolomide in patients with unresectable or metastatic leiomyosarcoma and other soft tissue sarcomas: A multicentre, single-arm, lead-in phase 2 trial. Lancet Oncol. Published online: January 16, 2026. doi:10.1016/S1470-2045(25)00654-0
