Interim results from the Phase 2/3 Duravelo-2 trial show that zelenectide pevedotin (BT8009) combined with pembrolizumab demonstrates strong anti-tumor activity and improved tolerability in patients with locally advanced or metastatic urothelial carcinoma.
Zelenectide pevedotin is a “Bicycle drug conjugate” designed to penetrate tumors rapidly and clear quickly from healthy tissue, reducing the severe side effects commonly seen with traditional antibody-drug conjugates targeting Nectin-4. This shorter exposure helps limit skin toxicity and other treatment-limiting complications.
In the optimized dosing group (6 mg/m² on days 1 and 8 every 21 days with pembrolizumab), the confirmed objective response rate reached 57.7%, including a 30.8% complete response rate. Treatment discontinuation due to adverse effects dropped to 3.3%, significantly lower than historical standards.
Side effects were generally mild, with low rates of severe skin reactions and neuropathy. The regimen may offer a promising first-line treatment option for advanced bladder cancer.