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Phase II TALASUR Trial to Study Maintenance Talazoparib Plus Avelumab in Urothelial Carcinoma

By: Kayci Reyer
Posted: Tuesday, January 17, 2023

The upcoming phase II TALASUR trial, details of which were presented in BMC Cancer, will seek to evaluate the efficacy and safety of joint administration of the PARP inhibitor talazoparib and the immune checkpoint inhibitor avelumab in urothelial carcinoma. This combination treatment will be investigated as maintenance therapy for patients with platinum-sensitive metastatic or locally advanced urothelial carcinoma.

“[Urothelial carcinoma] has targetable genomic alterations, including DNA damage repair (DDR) alterations. DDR deficiency is known to [be associated with] major sensitivity to both platinum-based chemotherapy and PD-1/PD-L1 blockade, and the combination of [immune checkpoint inhibitors] and PARP inhibitors showed promising results,” noted Elodie Coquan, MD, of Centre François Baclesse, Caen, France, and colleagues. “It therefore warrants [assessing] the interest of combining [immune checkpoint inhibitors] plus PARP inhibitors as maintenance treatment in [urothelial carcinoma] patients.”

The single-arm, multicenter study will include 50 patients with metastatic or locally advanced urothelial carcinoma who have already received platinum-based chemotherapy. Patients will receive 28-day cycles of 1 mg of daily talazoparib plus 800 mg of intravenous avelumab on days 1 and 15. The primary objective is efficacy measured by progression-free survival from treatment initiation. Secondary objectives include evaluating the treatment safety profile and measuring efficacy by overall survival, overall response rate, objective response rate, duration of response, disease control rate, treatment duration, quality of life, and time to subsequent therapy. Treatment discontinuation may occur due to unacceptable toxicity, disease progression, patient withdrawal, investigator’s decision, death, or other circumstances.

Disclosure: The study authors reported no conflicts of interest.


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