Johnson & Johnson (JNJ) announced on Friday the achievement of a primary safety endpoint in a Phase 1 trial for a drug delivery system designed to administer its bladder cancer therapy erdafitinib, developed with Otsuka (OTSKY) (OTSKF).
The open-label trial evaluated the intravesical drug-releasing system with erdafitinib (Erda-iDRS) in non–muscle-invasive bladder cancer (NMIBC) with fibroblast growth factor receptor (FGFR) alterations.
The study involving intermediate-risk and high-risk NMIBC patients met its primary safety endpoint and indicated an 89% complete response rate, a secondary endpoint, JNJ said. Regarding the duration of complete response, another secondary endpoint, the trial demonstrated 18 months as the median duration of complete response.
In terms of safety, there were no dose-limiting toxicities, while 9% of patients discontinued the study due to adverse events. Meanwhile, 2% of the subjects experienced serious treatment-related adverse events.
J&J (JNJ) added that the results support its ongoing Phase 2 and Phase 3 studies designed to test Erda-iDRS in intermediate- and high-risk non–muscle-invasive bladder cancer.