(UroToday.com) The 2026 AUA annual meeting featured a non invasive bladder cancer session and a presentation by Dr. Mark Tyson discussing ADVANCED-2 cohort A assessing interim 12 month efficacy and safety data in BCG-naïve participants with high grade non muscle invasive bladder cancer. There continues to be a significant unmet need for safe, effective, and bladder-sparing treatment options for patients with non muscle invasive bladder cancer, and this need is more pronounced in patients who are unable to receive BCG. TARA-002 is a lyophilized biological preparation for intravesical instillation containing inactivated cells of Streptococcus pyogenes (Group A, type 3) Su strain. TARA-002 rapidly enters cancer cells, activating TLR2 and NOD2 to trigger innate immunity, inflammation, and potential immunogenic cell death. Importantly, TARA-002 requires no special handling or thawing and can be rapidly administered via catheter by a healthcare professional in a routine office-based setting. This work, presented at the AUA 2026 annual meeting, reported interim efficacy and safety data of TARA-002 from the BCG-naïve cohort of the ADVANCED-2 study.
ADVANCED-2 (Cohort A) is an ongoing phase 2, open-label study to evaluate the safety and efficacy of intravesical TARA002 in adults ≥ 18 years with high-grade non muscle invasive bladder cancer CIS (±Ta/T1) who are BCG-naïve. Key exclusion criteria include (i) penicillin allergy, (ii) history of ≥ T2 bladder cancer, nodal, or metastatic disease, and (iii) concomitant prostatic or upper tract urothelial involvement. Each participant is treated with intravesical TARA-002 induction (6 weekly doses), reinduction (if disease persists at 3 months), and maintenance (through 24 months). Response is assessed every 3 months for 2 years, and long-term follow-up is conducted up to 60 months. Safety is monitored throughout the study. The primary endpoint is high grade complete response at any time according to central pathology, and the key secondary endpoint is duration of response at 12 months. The data cutoff is April 5, 2026, and enrollment is complete. The study schema for ADVANCED-2 Cohort A is as follows:
Overall, 31 BCG-naïve participants (median age: 71.0; range: 45 to 89) were enrolled. The majority of BCG-naïve participants are white (93.5%, 29 of 31), male (80.6%, 25 of 31), and non-Hispanic (90.3%, 28 of 31). The majority of participants had a baseline ECOG score of 0 (83.9%, 26 of 31) and baseline diagnoses of CIS only (58.1%, 18 of 31):
Over a median follow-up of 9.44 months (min: 2.4, max: 22.6 months), TARA-002 demonstrated 72.4% (21 of 29) high grade complete response at any time in evaluable participants. The 6-month complete response was 66.7% (18 of 27), the 9-month complete response was 61.1% (11 of 18), and the 12-month complete response was 55.0% (11 of 20):
Among responders, the Kaplan Meier estimated probability of maintaining a complete response for 6 months was 73.1% (95% CI 52.9-93.4), and 91.7% maintained their complete response from 9 to 12 months. Further, 66.7% (4 of 6) of re-induced participants converted to a complete response at 6 months:
The majority of treatment related adverse events were grade 1 and transient, with the most common event being dysuria, fatigue, and hematuria. No participants experienced grade 3 or greater treatment related adverse events, related serious adverse events, or treatment related adverse events leading to study drug withdrawal:
Dr. Tyson concluded his presentation discussing results from ADVANCED-2 cohort A with the following take home points:
- In BCG-naïve high grade non muscle invasive bladder cancer participants, TARA-002 demonstrated a high rate of complete response, with a substantial proportion maintaining a durable response at month 12
- Re-induction therapy successfully salvaged most initial non-responders, resulting in high conversion rates and durable responses
- TARA-002 was well tolerated, with common urinary treatment related adverse events reflect urinary tract instrumentation effects, and systemic treatment related adverse events were mild and easily managed
- These findings support continued investigation of TARA-002 in BCG-naïve high grade non muscle invasive bladder cancer
- A phase 3 randomized controlled study, ADVANCED-3 (NCT07480356), is planned to start this year
Presented by: Mark Tyson, MD, MPH, Mayo Clinic, Scottsdale, AZ
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.