Protara Therapeutics, Inc. announced updated positive interim results on April 26, 2025, from its ongoing Phase 2 ADVANCED-2 trial of TARA-002 in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients. The data, with an April 16, 2025, cutoff, demonstrated durable 12-month landmark responses in both BCG-Unresponsive and BCG-Naïve cohorts.
In the BCG-Unresponsive cohort (n=5), TARA-002 achieved a 100% complete response (CR) rate at six months, 80% at nine months, and 67% at 12 months (n=3 evaluable at 12 months). For the BCG-Naïve cohort (n=21), the CR rate was 63% at six months (n=16 evaluable), 63% at nine months (n=8 evaluable), and 43% at 12 months (n=7 evaluable).
The safety profile remained favorable, with the majority of adverse events being Grade 1 and transient. No Grade 3 or greater treatment-related adverse events (TRAEs) were observed, and no patients discontinued treatment due to TRAEs. These results were presented during an interactive poster session at the American Urological Association 2025 Annual Meeting.
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