Vofatamab on Fast Track for Advanced or Metastatic Bladder Cancer

Targeted Antibody for FGR3-Positive Mutation

Rainier Therapeutics, Inc.’s vofatamab has received FDA fast track designation for the treatment of patients with advanced or metastatic urothelial cell carcinoma that is positive for FGFR3 mutation and/or fusion.

The company has ongoing phase 1b and phase 2 clinical studies––Fierce 21 and Fierce 22––of vofatamab in metastatic bladder cancer. The company also plans to study the drug in early stage bladder cancer in the Fierce 23 trial.

Fierce 21 is evaluating vofatamab alone and in combination with docetaxel versus docetaxel alone to determine safety and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer with FGFR3 mutation/fusion who have relapsed after, or are refractory to, at least one previous line of chemotherapy.

Fierce 22 is evaluating vofatamab in combination with pembrolizumab to determine safety, tolerability, and efficacy in patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

Source: Rainier Therapeutics, January 8, 2019