KEY TAKEAWAYS
- The GEMDOCE phase 2 trial aimed to investigate the efficacy and safety of GemDoce as a 1L therapy for patients with BCG-naïve NMIBC.
- The primary endpoint was to determine CR.
- Researchers noticed favorable tolerability and promising efficacy of GemDoce in patients with BCG-naïve high-risk NMIBC.
A combination of intravesical Gemcitabine and Docetaxel (GemDoce) has shown effectiveness as a second-line therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Given the widespread shortages of Bacillus Calmette-Guérin (BCG), alternative treatments are crucial.
Sunil H. Patel and the team aimed to conduct a phase 2 prospective trial to evaluate GemDoce for BCG-naïve NMIBC.
They performed an inclusive analysis in a prospective single-arm open-label phase II trial for patients with BCG-naïve high-risk NMIBC. Intravesical gemcitabine and docetaxel were administered weekly for 6 weeks as induction, followed by monthly maintenance therapy for 2 years among responders. The primary endpoint was 3-month complete response (CR), and key secondary endpoints included adverse events (AE) and 12-month CR.
About 25 patients were enrolled between August 2020 and August 2022, with a median follow-up of 19.6 months. Pre-trial pathologic stages included HGT1 with CIS (n=7), HGT1 without CIS (n=6), HGTa (n=9), and CIS alone (n=3). The 3-month and 12-month CR rates were 100% and 88%, respectively. Recurrences of HGT1 occurred in 2 patients at 9 and 12 months.
No progression to T2 disease, radical cystectomy, or radiographic evidence of progressive disease was observed. Grade 1 AE’s were common (23/25 patients) including hematuria, urinary frequency, urgency, and fatigue. 5 patients (20%) experienced Grade 3 AE’s, including hematuria and UTI.
The study concluded that GEMDOCE demonstrated good tolerability and promising efficacy in patients with BCG-naïve high-risk NMIBC.
The trial was sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Source: https://www.auajournals.org/doi/10.1097/01.JU.0001008640.01272.9d.14
Clinical Trial: https://clinicaltrials.gov/study/NCT04386746
Patel S. H., Gabrielson A. T., Chan S, et al. (2024). “A PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND DOCETAXEL (GEMDOCE) IN THE TREATMENT OF BCG-NAÏVE NON-MUSCLE INVASIVE UROTHELIAL CARCINOMA OF THE BLADDER.” Presented at AUA 2024 (Abstract MP16-14).
