Protara Therapeutics (TARA) Study Update summary

Study design and patient population

• Ongoing open-label phase II ADVANCED-2 trial evaluates TARA-002 in high-risk NMIBC patients, including both BCG unresponsive and BCG naive cohorts, with carcinoma in situ.

• The BCG-unresponsive cohort is designed to be registrational, aligned with FDA guidance.

• Induction and maintenance dosing regimens are used, with reinduction for non-responders.

• Interim dataset includes 20 patients at three months, 18 at six months, and three at nine months.

• The trial includes 100 BCG-unresponsive and 27 BCG-naive patients.

Efficacy results

• Six-month landmark complete response (CR) rate was 72% across all patients; 70% CR at any time.

• BCG-unresponsive cohort showed 100% CR at six months and 80% CR at any time.

• BCG-naive cohort had a 64% CR at six months and 67% at any time.

• 100% durability of CR from three to six months in nine of nine patients.

• 80% reinduction salvage rate observed, outperforming other immune-activating therapies.

Safety and tolerability

• No grade two or higher treatment-related adverse events reported.

• No patient discontinuations due to adverse events.

• Most adverse events were grade one, transient, and consistent with immune potentiation.

• Most common urinary symptoms were mild and resolved quickly.