The Fierce-21 and Fierce-22 clinical trials of vofatamab are currently open for enrollment. The Fierce-23 trial is planned to open enrollment in 2019.

FIERCE-21

Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma 

The Fierce 21 trial is evaluating vofatamab alone and in combination with docetaxel versus docetaxel alone to determine safety and efficacy in the treatment of FGFR3 mutant/fusion patients with Stage IV, locally advanced or metastatic bladder cancer who have relapsed after, or are refractory to, at least one prior line of chemotherapy. For more on this trial, visit www.clinicaltrials.gov (NCT0240542).

FIERCE-22

A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma 

The Fierce 22 trial is evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of 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. For more on this trial, visit www.clinicaltrials.gov (NCT03123055).

FIERCE-23

The Fierce 23 will evaluate vofatamab monotherapy in non-muscle invasive bladder cancer (NMIBC) for patients who are unresponsive to Bacillus Calmette-Guerin (BCG) therapy. The study will explore 2 dose levels of vofatamab in patients with completely resected disease and a single dose level in patients with surgicaly unresectable disease. The study is planned to start in 2019.