- TARA-002 achieves a 100% complete response rate in BCG-Unresponsive patients.
- A 76% complete response rate observed in BCG-Naïve patients.
- TARA-002 exhibits a favorable safety profile with no severe adverse events.
Protara Therapeutics (TARA, Financial), a clinical-stage company, revealed promising interim results from its ongoing Phase 2 ADVANCED-2 trial of TARA-002 for treating Non-Muscle Invasive Bladder Cancer (NMIBC). The cell-based therapy demonstrated impressive efficacy across both patient cohorts, highlighting its potential as a transformative treatment option.
In the BCG-Unresponsive cohort, consisting of five patients, TARA-002 achieved a complete response rate of 100% at any time, which remained at 100% at six months, reduced to 80% at nine months, and maintained a 67% response at 12 months.
In the BCG-Naïve cohort with 21 patients, the complete response rate stood at 76% at any time, with sustained rates of 63% at both six and nine months, and 43% at 12 months. These results indicate significant clinical activity and durability in a challenging patient population.
TARA-002 also exhibited a favorable safety profile, with no Grade 3 or greater treatment-related adverse events reported. The observed side effects were mild and transient, allowing all patients to continue their treatment without interruption.
Protara Therapeutics is on track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025, which will further illuminate the efficacy and safety profile of TARA-002. The company will host a conference call and webcast to discuss these findings on April 28, 2025, at 8:30 a.m. ET.
