(UroToday.com) The American Urological Association (AUA) 2025 Annual Meeting, held in Las Vegas, NV, was host to a bladder cancer clinical trials in progress session. Dr. Brian Mazzarella presented Advanced-2, a phase II, open-label study evaluating the safety and efficacy of TARA-002 intravesical instillations in adult patients with high-grade, non-muscle invasive bladder cancer (NMIBC).
Approximately 80,000 people are diagnosed with bladder cancer annually in the United States, and it is estimated that there are ~725,000 people currently living with bladder cancer in the United States.
TARA-002 is a broad immunopotentiator that has the potential for durable responses. It has a mechanism of action that is similar to that of BCG. It activates the Th1 immune cascade, leading to a pro-inflammatory cascade that destroys tumoral cells.
ADVANCED-2 is a single arm registrational trial in BCG unresponsive patients with CIS +/- Ta/T1 disease. Eligible patients (n=100) will receive induction therapy (6 weekly instillations), followed by maintenance therapy (3 weekly instillations every 3 months) over a 15-month period (months 3–18). All patients will undergo a mandatory biopsy at 3 months to ascertain the complete response status. Re-induction is permitted in select patients.
The key inclusion and exclusion criteria are as follows:
The proof-of-concept study in BCG-naïve patients with CIS +/- Ta/T1 disease (n=31) has completed enrollment.
The primary endpoint of both the ADVANCED-2 registrational trial in BCG-unresponsive and proof-of-concept trial in BCG-naïve patients is high-grade complete response at any time. The additional endpoints are summarized below:
There are ongoing plans for the addition of exploratory systemic dosing cohorts, as follows:
Presented by: Brian Mazzarella, MD, Urology Austin, Austin, TX
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 American Urological Association (AUA) annual meeting held in Las Vegas, NV, Saturday, April 26 - Tuesday, April 29, 2025
Related content: ADVANCED-2 Trial: TARA-002 in BCG-Naive High-Risk NMIBC - Brian Mazzarella