TARA-002 Achieves 72% Complete Response Rate in Phase 2 NMIBC Trial, Highlighting Strong Potential in BCG-Naive Patients

Updated Data Signals Durable Responses and Positive Regulatory Feedback

Protara Therapeutics has announced updated interim results from its ongoing Phase 2 ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC). Among BCG-naive patients—those who have not been treated with the current standard Bacillus Calmette-Guérin (BCG)—TARA-002 delivered a complete response (CR) rate of 72% at any time, with favorable results observed at both six and twelve months. The latest data reinforces the treatment's strong clinical potential and regulatory momentum.

Strong and Durable Response Rates Across Key Milestones

The study evaluated 31 BCG-naive NMIBC patients who received at least one dose of TARA-002. Evaluable data was available for 29 patients as of the November 2025 data cutoff. Results demonstrated:

Additionally, among initial responders, 88% (14/16) maintained their response through six months, while all initial responders followed to twelve months (3/3) remained disease-free. Re-induction therapy also contributed, with 80% of non-responders achieving CR at six months and all maintaining their response through twelve months.

Safety Profile Remains Favorable and Tolerable

Importantly, TARA-002 was associated with a strong safety profile. The majority of treatment-related adverse events (TRAEs) were Grade 1 (mild and transient), and there were no reports of Grade 3 or higher events. Common side effects included dysuria (13%), fatigue (13%), and hematuria (6%). No patients discontinued due to adverse events.

FDA Feedback Supports Clear Registrational Path Forward

Protara reported productive feedback from the FDA regarding the registrational path for TARA-002. Notably, the agency agreed that BCG is not required as a comparator for future studies in BCG-naive patients. Intravesical chemotherapy will serve as the control, and the six-month complete response rate will be the primary endpoint. The FDA is also engaged with Protara to potentially include BCG-exposed patients, a group with significant unmet need, in future trials.

Upcoming Milestones and What to Watch

Interim results for the BCG-unresponsive cohort (another population with few treatment options) are expected in Q1 2026, with enrollment for that cohort expected to be completed in the second half of 2026. Investors and researchers may wish to follow upcoming data releases, as positive outcomes could significantly influence the NMIBC treatment landscape.

Key Takeaways: Clinical Potential and Industry Momentum

TARA-002's high and durable response rates in BCG-naive NMIBC patients, coupled with a favorable safety profile and a regulatory green light for pivotal studies, suggest that this therapy could become a leading option for patients with limited alternatives. While continued data and final outcomes remain to be seen, today's results point to meaningful progress in both clinical efficacy and the regulatory process for Protara Therapeutics.

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