Protara shares positive Phase 2 bladder cancer data at 12 months

Protara Therapeutics (NASDAQ:TARA) reported updated 12-month interim data from the Cohort A arm of its Phase 2 ADVANCED-2 clinical trial, demonstrating sustained tumor clearance and a favorable safety profile for its lead oncology candidate.

The New York-based biopharmaceutical company stated that its investigational therapy, TARA-002, generated a 72% complete response rate at any point during the observation window among evaluated patients with high-grade, Bacillus Calmette-Guérin (BCG)-naïve non-muscle invasive bladder cancer.

According to the study's timeline metrics, the intravesical treatment maintained a 67% complete response rate at the 6-month evaluation mark, which subsequently stood at 55% at the 12-month threshold.

The data indicate a competitive durability profile for the biological preparation, which is designed to activate local innate immune pathways to trigger immunogenic cell death within malignant urothelial tissue.

On the safety front, the investigational treatment was well tolerated by the trial participants.

The vast majority of reported treatment-emergent adverse events were classified as Grade 1 and characterized as transient in nature.

No Grade 3 or higher treatment-related adverse events were documented during the 12-month tracking period.

The clinical update comes as Protara advances its broader regulatory strategy for the compound.

Management plans to leverage these data to initiate its ADVANCED-3 registrational trial in the BCG-naïve patient population during the second half of 2026, alongside finishing enrollment for its parallel BCG-unresponsive cohort within the ongoing ADVANCED-2 protocol.