Tony Berberabe, MPH

The investigators concluded that a phase 3 trial is warranted.

Investigators reported that all responders had FGFR3 mutations and that most non-responders had a prior history of bladder cancer, with 1 patient having a FGFR3-TACC3 fusion.

The investigators concluded that time to event end points and response rates were similar regardless of which first-line immunotherapy was administered.

The combo of the PARP inhibitor niraparib and the multikinase inhibitor cabozantinib showed positive early efficacy and safety signals in patients with metastatic urothelial carcinoma or renal cell carcinoma.

The findings showed a benefit for the immunotherapy/TKI regimen over sunitinib in adjusted overall survival as well as in the type and timing of subsequent therapy.

Based on these findings, an application has been filed with the FDA to expand enfortumab vedotin’s approval to include cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor.