TARA-002 Achieves 72% Complete Response in BCG-Naïve NMIBC: Promising Data from ADVANCED-2 Trial
Durable Complete Response Rates Stand Out for TARA-002
Protara Therapeutics released updated interim data for its investigational therapy TARA-002 in non-muscle invasive bladder cancer (NMIBC), specifically targeting patients who have not previously received Bacillus Calmette-Guérin (BCG) treatment. As of the November 7, 2025 data cutoff, TARA-002 showed a notable 72% complete response (CR) rate at any time among evaluable BCG-naïve NMIBC patients, with durable efficacy observed at 6 and 12 months.
Strong Efficacy and Durability Backed by Key Trial Results
The interim analysis from the Phase 2 ADVANCED-2 trial involved 31 BCG-naïve patients who received at least one dose of TARA-002, with 29 considered evaluable for efficacy. The regimen included six weekly intravesical instillations, followed by maintenance every three months, and permitted re-induction for those with persistent or recurrent disease.
| Metric | Patients (n) | Response Rate |
|---|---|---|
| CR Rate (Any Time) | 29 | 72% |
| CR Rate at 6 Months | 26 | 69% |
| CR Rate at 12 Months | 14 | 50% |
| Maintained CR at 6 Months (Initial Responders) | 16 | 88% |
| Maintained CR at 12 Months (Initial Responders) | 3 | 100% |
| Re-Induction Success at 6 Months | 5 | 80% |
| Re-Induction Maintained at 12 Months | 4 | 100% |
Safety Profile Remains Favorable With Low Grade Adverse Events
In addition to efficacy, TARA-002 demonstrated a favorable safety and tolerability profile. Most treatment-related adverse events (TRAEs) were mild (Grade 1), with no Grade 3 or greater events and no discontinuations due to TRAEs. The most frequent side effects were dysuria and fatigue (each reported by 13% of patients) and hematuria (6%).
Regulatory Feedback Provides a Clear Path Forward
The U.S. Food and Drug Administration (FDA) has offered written support for a controlled registrational trial in BCG-naïve patients, endorsing intravesical chemotherapy as a suitable comparator instead of BCG. The agreed-upon primary endpoint will be the complete response rate at six months, with response duration as a key secondary measure. The company remains in ongoing dialogue to expand trial access and possibly include BCG-exposed patients, who currently lack approved options.
Next Steps: Awaiting More Data and Potential Clinical Impact
Protara expects to deliver additional interim results from BCG-unresponsive patients in the first quarter of 2026 and to finish enrollment for that cohort by the second half of 2026. TARA-002's promising results and manageable side effect profile continue to support its potential as a treatment for BCG-naïve NMIBC patients—an area with significant unmet need.
Key Takeaway: Data Suggest TARA-002 Could Address Gaps in Bladder Cancer Treatment
While these results are preliminary, the observed response rates and durability position TARA-002 as a compelling option for further clinical study. Investors, clinicians, and patients will be closely watching the progress of the registrational trials as Protara engages with regulators and prepares for broader enrollment in the coming year.
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