Intravesical Gemcitabine, Docetaxel for BCG-Naïve NMIBC

A phase 2 clinical trial assessed combination intravesical gemcitabine and docetaxel (GemDoce) for bacillus Calmette-Guérin (BCG)-naïve non-muscle invasive bladder cancer (NMIBC).

Results of the assessment were presented at the 2024 American Urological Association Annual Meeting.

Previous research has demonstrated positive efficacy for GemDoce as a second-line treatment option in patients with BCG-unresponsive NMIBC.

Sunil H. Patel, MD, and colleagues designed a prospective, single-arm, open-label, phase 2 trial of 25 patients with BCG-naïve NMIBC enrolled from August 2020 to August 2022. The pathologic stages at baseline were HGT1 with carcinoma in situ (CIS; n=7), HGT1 without CIS (n=6), HGTa (n=9), and CIS alone (n=3).

Patients were given intravesical GemDoce weekly for 6 weeks as induction, and responders were given monthly maintenance therapy for 2 years.

The primary end point of the study was 3-month complete response (CR). Key secondary end points included adverse events (AEs) and 12-month CR.

After a median follow-up of 19.6 months, the 3.0- and 12.0-month CR rates were 100% and 88%, respectively. Researchers noted that 2 patients with baseline HGT1 disease had HGT1 recurrences at 9 and 12 months.

No patients in the study progressed to T2 disease, underwent radical cystectomy, or had any radiographic evidence of progressive disease, they added.

Twenty-three of the patients experienced grade 1 AEs, including hematuria, urinary frequency, urgency, and fatigue. Additionally, 5 patients experienced grade 3 AEs, including hematuria or urinary tract infection. No grade 4 or 5 AEs were observed.

These results led Dr. Patel and colleagues to conclude that “GemDoce was well tolerated with promising efficacy for patients with BCG-naïve NMIBC.”