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Durvalumab Plus Cabozantinib in Advanced Urothelial Cancer: ARCADIA Trial

By: Susan Reckling
Posted: Friday, October 30, 2020

The checkpoint inhibitor durvalumab and the MET, AXL, and VEGFR inhibitor cabozantinib have both shown single-agent activity in patients with urothelial cancer. Consequently, Laura Marandino, MD, of the Istituto Nazionale dei Tumori, Milan, Italy, and colleagues conducted the phase II ARCADIA trial to assess the effectiveness of combining these two agents in this patient population. Early clinical activity was demonstrated with the combination regimen, although more mature results with longer follow-up are forthcoming. These findings were presented as an e-poster at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 773P).

A total of 14 patients were enrolled in this study as of May 2019, with a median follow-up of 5 months. The median age of patients was 66 years, nearly approximately one-quarter were men, and many patients (60%) had an Eastern Cooperative Oncology Group performance status of 1. Four patients had received two prior systemic therapies.

Nine patients experienced treatment-related adverse events, and all were either grade 1 or 2, during the first two cycles of therapy. One patient stopped cabozantinib due to toxicity, and no patients stopped durvalumab as a result of toxicity. Asthenia was the most common treatment-related adverse event reported in 28.6% of treated patients. Diarrhea, creatinine increase, and hypertension were observed in 21.4% of patients.

In terms of early efficacy, of the 10 response-evaluable patients, a partial response was seen in 2 patients. In one case with a driver RET mutation, the response was ongoing at more than 6 months. Nearly 30% of patients experienced a clinical benefit (partial response plus stable disease).

Disclosure: The study authors reported no conflicts of interest.

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