Protara Therapeutics Announces Updated Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients

Core Insights - Protara Therapeutics announced updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for treating non-muscle invasive bladder cancer (NMIBC) [1][2] - The results indicate a promising potential for TARA-002 in the NMIBC treatment landscape, particularly for Bacillus Calmette-Guérin (BCG)-Naïve patients [2] Updated Interim Results - The dataset includes 31 BCG-Naïve patients, with 29 evaluable for efficacy as of November 7, 2025 [3] - TARA-002 demonstrated a 72% complete response (CR) rate at any time, a 69% CR rate at six months, and a 50% CR rate at 12 months [4][5] - Among initial responders, 88% maintained their response through six months and 100% through 12 months [5] - Re-induction therapy showed high conversion rates, with 80% of re-induced patients achieving CR at six months [5] Safety Profile - The treatment exhibited a favorable safety and tolerability profile, with no Grade 3 or greater treatment-related adverse events reported [4][6] - Common treatment-related adverse events included dysuria (13%), fatigue (13%), and hematuria (6%) [6] Regulatory Update - The company is in dialogue with the FDA regarding the registrational path for TARA-002, with written feedback supporting a controlled trial design for BCG-Naïve patients [7] - The FDA has agreed that BCG is not required as a comparator, and intravesical chemotherapy is acceptable [7] About ADVANCED-2 Trial - ADVANCED-2 is a Phase 2 open-label trial assessing TARA-002 in NMIBC patients with carcinoma in situ or CIS [8] - The trial includes both BCG-Unresponsive and BCG-Naïve cohorts, with ongoing enrollment expected to complete in the second half of 2026 [9] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases, with TARA-002 as its lead candidate [14]