Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has published data from a Phase IIb study demonstrating the efficacy of its intravesical gemcitabine delivery system, TAR-200, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) carcinoma in situ-positive. The study results are a significant step forward in the treatment of this challenging condition.
Study Results and Response Rates
The study showed a complete response (CR) rate of 77% as confirmed by urine cytology and/or biopsy. Furthermore, the investigator-confirmed CR rate reached 80%, indicating a high level of efficacy. Importantly, the median duration of response (DOR) was not reached after 1 year of follow-up, suggesting sustained benefits for patients.
Implications for Bladder Cancer Treatment
These findings highlight the potential of TAR-200 to become a valuable treatment option for patients with HR-NMIBC who have not responded to standard therapies. The intravesical delivery system offers a targeted approach to treatment, potentially improving outcomes and reducing the need for more invasive procedures.-Fineline Info & Tech
