Protara Therapeutics (NASDAQ:TARA) on February 23, 2026, announced updated interim data from its ongoing Phase 2 ADVANCED-2 trial evaluating intravesical TARA-002 in patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ who are either BCG-unresponsive or BCG-naïve.
The open-label study results, based on a data cutoff of January 28, 2026, will be presented on February 27 at the ASCO Genitourinary Cancers Symposium. The company reported strong complete response rates and encouraging durability across both patient groups.
Among patients in the BCG-unresponsive cohort, TARA-002 achieved a complete response at any time in 65.7% of evaluable participants, with a 68.2% response rate at six months and evidence of sustained responses through 12 months among those with longer follow-up.
In the BCG-naïve cohort, the therapy delivered a complete response rate of 72.4% at any timepoint, with rates of 66.7% at six months and 57.9% at 12 months. Re-induction treatment converted a majority of initial non-responders in both cohorts, further supporting the therapy’s potential effectiveness.
Safety findings indicated favorable tolerability, with most treatment-related adverse events limited to transient Grade 1 bladder or systemic symptoms. The study reported no Grade 3 or higher treatment-related adverse events, no related serious adverse events, and no discontinuations linked to toxicity.
Protara said the results, combined with a streamlined intravesical administration approach, reinforce TARA-002’s potential role as a new treatment option for non-muscle invasive bladder cancer and strengthen the company’s clinical and commercial outlook.
Operationally, the company expects to complete enrollment of the BCG-unresponsive registrational cohort in the ADVANCED-2 study during the second half of 2026. Enrollment in the BCG-naïve cohort has already been completed with 31 patients. Protara also plans to launch the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of 2026, marking a further step toward potential regulatory approval.
More about Protara Therapeutics
Protara Therapeutics, Inc. is a New York–based clinical-stage biotechnology company developing therapies for cancer and rare diseases. Its lead program, TARA-002, is an investigational cell-based therapy being studied for non-muscle invasive bladder cancer and lymphatic malformations. The company is also advancing an intravenous choline chloride therapy for patients receiving parenteral nutrition. Protara is focused on addressing significant unmet needs in high-risk bladder cancer, particularly among patients who are unresponsive to or have not received Bacillus Calmette-Guérin treatment.