(UroToday.com) The 2026 AUA annual meeting featured a non invasive bladder cancer session and a presentation by Dr. Boris Chertin discussing updated 12 month complete response data from a prospective open-label study evaluating the efficacy of intravesical sustained release gemcitabine + docetaxel combination in high risk non muscle invasive bladder cancer. Sequential intravesical gemcitabine + docetaxel represents a promising option to treat patients with high-risk non muscle invasive bladder cancer, including those who are BCG-naïve, -exposed, and -unresponsive. Gemcitabine + docetaxel is not available in a sustained-release formulation, limiting intravesical exposure. As such, NDV-01 is an investigational intravesical agent designed for sustained release of gemcitabine + docetaxel continuously over a 10-day period. Importantly, NDV-01 does not require a specialized pharmacy or hood and can be administered in <5 minutes. NDV-01 may also help overcome the burdens to patients and to providers of traditional gemcitabine + docetaxel instillation.
TRCG-011 is a phase 2, single-arm, open-label trial of NDV-01 in subjects with high grade non muscle invasive bladder cancer. Subjects were given 6 bi-weekly instillations followed by monthly maintenance instillations through month 12. Complete response was defined as a negative cystoscopy, cytology, and biopsy (if indicated), and the first assessment for complete response was evaluated at 3 months. Subjects with a non-complete response at 3 or 6 months were eligible to be re-induced with an additional 6 bi-weekly courses of therapy. Disease assessments for complete response were also performed at 6, 9, and 12 months. There were 38 patients who have reached the first disease assessment (3-months follow-up) and are included in the per-protocol efficacy analysis, with 10 patients pending their first response assessment. All 48 patients who have received >=1 treatment are included in the safety analysis. The study design of TRCG-011 is as follows:
Baseline characteristics of the 48 enrolled subjects are shown in the following table:
Of note, all patients had an ECOG performance score of 0-1. Among the 48 patients who received >=1 dose of NDV-01, 30 (63%) had a treatment related adverse event (54% dysuria, 8% asymptomatic positive urine culture, and 8% hematuria). No patient had >=Grade 3 treatment related adverse event, and no patients discontinued treatment due to adverse events. Response rates in the 38 patients who received >=3-month disease assessment are shown in the following table (95% anytime complete response rate), including 25 patients who have reached the 12-month assessment (12 month complete response rate: 76%):
Dr. Chertin also provided complete response rates in the BCG-unresponsive subpopulation, which were notable for a 12 month complete response rate of 80%:
No patient had progression to muscle invasive disease, and no patient has undergone a cystectomy. The following figure highlights the Swimmer plot for all patients enrolled in the TRCG-011 trial:
Dr. Chertin concluded his presentation discussing updated 12 month complete response data from a prospective open-label study evaluating the efficacy of intravesical sustained release gemcitabine + docetaxel combination with the following take home points:
- NDV-01 is a novel sustained formulation of gemcitabine + docetaxel for intravesical use
- NDV-01 provides a durable 76% complete response rate at 12 months, with a 95% complete response rate at any time in high risk non muscle invasive bladder cancer
- The tolerability profile remains favorable, with no >= grade 3 treatment related adverse events and no treatment related discontinuations
- Next steps include:
- Initiate the phase 3 RESCUE trial in mid-2026
- Targeting two independent registrational pathways: second line BCG-unresponsive non muscle invasive bladder cancer and adjuvant intermediate risk non muscle invasive bladder cancer
Presented by: Boris Chertin, Shaare Zedek Medical Center, Jerusalem, Israel
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the American Urological Association (AUA) 2026 Annual Meeting, Washington, DC, Fri, May 15 – Mon, May 18, 2026.