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# Protara Reports Positive Data on Bladder Cancer Drug
- URL: https://www.fdaweb.com/protara-reports-positive-data-on-bladder-cancer-drug/
- Published: 2024-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:48:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158313

Protara Therapeutics is reporting encouraging data from the Phase 2 open-label ADVANCED-2 trial of its cell-based TARA-002 in high-risk non-muscle invasive bladder cancer patients with carcinoma in situ who are Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-naïve. “The complete response (CR) rate across BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time with 100% (9/9) of patients maintaining a CR from three months to six months,” it says, adding that two of three patients maintained a CR at nine months.

Protara says the “impressive” data demonstrate “meaningful activity in a difficult-to-treat patient population. Additionally, TARA-002 in the trial showed a favorable safety and tolerability profile, including, it says, no Grade 2 or greater treatment-related adverse events, and no patients discontinued due to adverse events.

The therapy is believed to work by activating innate and adaptive immune cells within the cyst or tumor to produce a pro-inflammatory response that releases cytokines. “TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response,” Protara says.