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A phase II trial of durvalumab (MEDI4736) and tremelimumab in metastatic, nontransitional cell carcinoma of the urothelial tract

Journal of Clinical Oncology Feb 26, 2020

Sarfaty M, Ostrovnaya I, Teo MY, et al. - Researchers tested durvalumab and tremelimumab for activity and safety in patients with metastatic non-transitional cell carcinoma of the urothelial tract (non-TCC) in this single-arm, phase II study. The cases eligible for inclusion were those with unresectable/metastatic non-TCC with ECOG PS 0-1 irrespective of previous therapy (except for patients with small cell carcinoma who must have progressed post-chemotherapy). The treatment regimen used was: durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 cycles, then durvalumab 1500 mg IV Q4W for a total treatment duration of 12 months. The overall response rate by RECIST 1.1 was assessed as the primary endpoint. Overall 13 patients received the treatment, including 7 (54%) with small cell carcinoma, 3 (23%) with squamous cell carcinoma, and 3 (23%) with adenocarcinoma. A median follow-up of 6.8 months revealed a median PFS of 1.8 months and median OS of 6.43 months. The occurrence of grade 3-4 treatment-related adverse events was seen in 31% of patients. Findings revealed no responses to treatment with durvalumab and tremelimumab in this poor prognosis cohort of patients with non-TCC. There is an urgent requirement for new therapeutic strategies for patients with metastatic non-TCC.
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