Combining the antibody drug conjugate, enfortumab vedotin (Padcev) with the immune checkpoint inhibitor pembrolizumab (Keytruda) showed encouraging results in patients with locally advanced or metastatic urothelial cancer who were unable to receive cisplatin-based chemotherapy in the first-line setting.
Preliminary results from a single-arm study demonstrated promising progression-free survival (PFS) and a clinically meaningful objective response rate (ORR) with the combination of pembrolizumab (Keytruda) and nab-paclitaxel (Abraxane) as second- or third-line therapy in patients with advanced urothelial carcinoma.
On June 30, 2020, the FDA approved avelumab (Bavencio; Pfizer) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This approval was based on results of the randomized, multicenter, open-label, phase 3 JAVELIN Bladder clinical trial. This study enrolled 700 patients with unresectable, locally advanced, or metastatic urothelial carcinoma that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy. Patients were randomized to avelumab given intravenously every 2 weeks plus best supportive care (BSC) or BSC alone.
Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.