Protara Therapeutics disclosed that its Phase 2 ADVANCED‑2 trial of the investigational cell‑based therapy TARA‑002 has achieved encouraging interim results in 31 BCG‑naïve patients with carcinoma in situ or CIS (± Ta/T1) non‑muscle invasive bladder cancer (NMIBC). 29 of the patients were evaluable for efficacy as of a November 7, 2025 data cutoff, and the trial reported a complete response (CR) rate of 72 % at any time, 69 % at the six‑month landmark, and 50 % at the twelve‑month landmark. 88 % of initial responders maintained CR through six months, and all evaluable patients sustained CR through twelve months. Safety data were favorable, with most treatment‑related adverse events being Grade 1 and transient; no Grade 3 or higher events or discontinuations due to adverse events were reported.
The U.S. Food and Drug Administration’s written feedback, received in the same week, confirmed that CR at six months is an appropriate primary endpoint for a future registrational trial and identified duration of response as a key secondary endpoint. The FDA also agreed on a comparator arm of intravesical chemotherapy, thereby supporting a clear regulatory pathway for TARA‑002 in the BCG‑naïve population. This alignment with FDA expectations reduces regulatory uncertainty and positions the program for a potential accelerated development schedule.
CEO Jesse Shefferman emphasized that the data “demonstrate the clinical potential of TARA‑002 and reinforce our confidence in the program’s trajectory.” Dr. Mark Tyson, a principal investigator on the study, noted that the durability of responses “provides a compelling signal that TARA‑002 can achieve sustained disease control in a patient group with limited options.” Both leaders highlighted the importance of the trial’s safety profile, noting that the absence of high‑grade toxicity supports the feasibility of a larger, controlled study.
The interim data build on an earlier release in April that reported 21 BCG‑naïve patients. The expansion to 31 patients reflects steady enrollment momentum and strengthens the statistical power of the efficacy signals. The updated results were presented at the 26th Annual Meeting of the Society of Urologic Oncology on December 4, 2025, following the company’s announcement the day before.
The positive efficacy and safety profile, coupled with FDA endorsement of the trial design, de‑risk the TARA‑002 program and enhance its attractiveness as a potential alternative to BCG for patients who have never received the vaccine. The data suggest that TARA‑002 could fill a critical unmet need in NMIBC, potentially reducing the need for radical cystectomy and improving patient quality of life. The company will continue to pursue a registrational trial, with the next milestone being the initiation of a randomized, controlled study that will further validate the durability and clinical benefit of TARA‑002.
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