Mark Tyson, MD, highlights ADVANCED-2 trial in BCG-naïve NMIBC

TARA-002 demonstrated promising safety and initial efficacy in patients with BCG-naïve non–muscle invasive bladder cancer (NMIBC), according to interim results from the ADVANCED-2 trial (NCT05951179) presented at the 2025 Society of Urology Oncology Annual Meeting in Phoenix, Arizona.¹

According to the authors, 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.”

In an interview with Urology Times®, presenting author Mark D. Tyson, II, MD, MPH, of Mayo Clinic, Phoenix, Arizona, highlighted the key interim findings from the ADVANCED-2 trial and shared his thoughts on the potential implications of TARA-002 for clinical practice.

At the time of data collection, the trial had enrolled 31 patients with BCG-naïve NMIBC who had received at least 1 dose of TARA-002. Of these, 29 patients had completed at least 1 response assessment and were evaluable for efficacy. The primary end point is high-grade complete response (CR) at any time point, and the secondary end point is duration of response.

Overall, data showed a CR rate at any time of 72%. The CR rate was 69% at 6 months and 50% at 12 months. Among those with an initial response to treatment, 88% remained in response through 6 months, and 100% through 12 months.

Five patients in the trial underwent re-induction therapy, of whom 80% (4 of 5) converted to a CR at 6 months, and 100% maintained their CR at 12 months.

Treatment was also well-tolerated in the study. Treatment-related adverse events (TRAEs) were generally grade 1 and transient, and there were no grade 3 or higher TRAEs reported. The most common TRAEs were dysuria (13%), fatigue (13%), and hematuria (6%).

Based on these fidnigns, Protara Therapeutics has been in communication with the FDA to align on the design for a registrational trial for TARA-002 in the BCG-naïve setting.²

REFERENCES
1. Tyson M, Jayram G, Doronina MV, et al. ADVANCED-2: preliminary efficacy and safety data in BCG-naïve participants with high-grade non-muscle invasive bladder cancer. Presented at: Society of Urologic Oncology Annual Meeting; December 2-5, 2025; Phoenix, Arizona. Abstract 149. https://suo-abstracts.secure-platform.com/a/gallery/rounds/24/details/4688

2. Protara Therapeutics announces updated interim data from phase 2 ADVANCED-2 trial of TARA-002 in BCG-naïve NMIBC patients. News release. Protara Therapeutics. December 3, 2025. Accessed January 13, 2025. https://ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-announces-updated-interim-data-phase-2