Clinical TrialMay 15, 2026, 07:01 AM
Protara TARA-002 Shows 55% CR Rate at 12 Months in NMIBC Trial
AI Summary
Protara Therapeutics announced positive updated 12-month data from Cohort A of its Phase 2 ADVANCED-2 trial for TARA-002 in BCG-Naïve non-muscle invasive bladder cancer (NMIBC) patients. The trial demonstrated a 72% complete response (CR) rate at any time, with 67% at 6 months and 55% at 12 months. TARA-002 also showed a favorable safety profile with no Grade 3 or greater treatment-related adverse events. The company plans to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in the second half of 2026.
Key Highlights
- TARA-002 demonstrated a 72.4% complete response rate at any time in BCG-Naïve NMIBC patients.
- The complete response rate was 66.7% at 6 months and 55.0% at 12 months.
- No Grade 3 or greater treatment-related adverse events were reported.
- The Kaplan-Meier estimated probability of maintaining a complete response for six months was 73.1%.
- 91.7% of responders maintained their complete response from nine to 12 months.
- Protara Therapeutics plans to initiate the ADVANCED-3 registrational trial in 2H 2026.
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