Protara’s TARA-002 Achieves 68% Six-Month NMIBC Response Rate
Interim analysis of Protara’s ADVANCED-2 trial in 35 BCG-unresponsive NMIBC patients reported a 68.2% complete response rate at six months, 71.1% Kaplan-Meier durability and no Grade 3 or higher treatment-related adverse events. BCG-naïve cohort of 27 patients showed 72.4% CR, 66.7% at six months and 100% durability from nine to 12 months.
1. Interim ADVANCED-2 Trial Results
The interim analysis evaluated 35 BCG-unresponsive Non-Muscle Invasive Bladder Cancer patients receiving TARA-002, revealing a 68.2% complete response rate at six months and a Kaplan-Meier estimated 71.1% probability of maintaining response over six months.
2. Cohort-Specific Outcomes
In the BCG-naïve cohort of 27 patients, TARA-002 achieved a 72.4% complete response rate at any time, 66.7% at six months and sustained 100% response from nine to 12 months. Re-induction patients saw a 66.7% conversion to complete response at six months.
3. Safety Profile and Next Milestones
No Grade 3 or greater treatment-related adverse events were reported, underscoring a favorable tolerability profile. Protara expects to complete enrollment of the BCG-naïve cohort in the second half of 2026, advancing TARA-002 toward pivotal development stages.