TARA-002 Shows 72% Complete Response Rate in BCG-Naive NMIBC Patients—Phase 2 Trial Interim Data Revealed
Phase 2 Data Underscores Strong Clinical Benefit
Protara Therapeutics (NASDAQ: TARA) has reported updated interim data from its ongoing Phase 2 ADVANCED-2 trial of TARA-002 for patients with non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guerin (BCG) treatment. The results—announced as of November 7, 2025—highlight a promising 72% complete response (CR) rate at any time among BCG-naive patients.
The study, which will be showcased at the Society of Urologic Oncology Annual Meeting, found 69% of participants achieved a complete response at the 6-month mark, and 50% maintained it at 12 months. For patients needing a second course, 80% responded at 6 months, with 100% of those sustaining response at 12 months.
| Patient Subset | CR Rate (Any Time) | CR Rate (6 Months) | CR Rate (12 Months) |
|---|---|---|---|
| All BCG-Naive | 72% | 69% | 50% |
| Initial Responders Maintaining Response | - | 88% | 100% |
| Re-Induction Responders (Maintained at 12 Months) | - | 80% | 100% |
Safety Profile Remains Favorable With No Severe Adverse Events
The majority of adverse events related to TARA-002 treatment were mild (Grade 1) and short-lived, with no Grade 3 or higher events observed. Common treatment-related effects included dysuria and fatigue (each reported by 13% of patients) and hematuria (6%). Notably, no participants discontinued therapy due to side effects.
| Adverse Event | Frequency | Grade 3 or Greater? |
|---|---|---|
| Dysuria | 13% | No |
| Fatigue | 13% | No |
| Hematuria | 6% | No |
Regulatory Alignment Paves Way for Future Expansion
The FDA has provided written feedback supporting a registrational pathway for TARA-002 in BCG-naive NMIBC, agreeing that a comparison to intravesical chemotherapy (rather than BCG) is acceptable and endorsing the six-month complete response rate as a primary endpoint. Protara also aims to include BCG-exposed patients—an underserved group lacking FDA-approved treatments—in future trials.
Key Takeaway: Interim Results Reinforce Promise of TARA-002 in NMIBC
The latest Phase 2 results bolster the case for TARA-002 as a potential first-line therapy for BCG-naive NMIBC, with meaningful and durable response rates alongside a reassuring safety profile. As the ADVANCED-2 trial progresses, interim data on BCG-unresponsive patients are expected in early 2026, with full enrollment anticipated by the end of 2026.
For those watching the space, the regulatory dialogue and clinical durability of response could position TARA-002 as an important addition to the bladder cancer treatment landscape. Further results next year will be crucial to see whether these trends hold as patient numbers expand.
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