Thomas Cannell, DVM
Vicinium led to 6- and 12-month complete response (CR) rates in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who did not respond to Bacillus Calmette-Guérin (BCG) therapy, according to updated results of the phase III VISTA trial (NCT02449239).1
Across 2 of the 3 patient cohorts, the 6-month CR rate was 28% (95% CI, 19%-39%) and the 12-month CR rate was 17% (95% CI, 10%-26%) in patients with carcinoma in situ (CIS) who had received prior BCG therapy.
These data will serve as the basis for a biologics license application (BLA) that will likely be submitted to the FDA in the fourth quarter of 2019, Sesen Bio, the developer of Vicinium, stated in a press release. Following the submission, the company stated that an Oncologic Drugs Advisory Committee meeting is expected to take place to review the risk-benefit profile of Vicinium.
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