TARA-002 shows 68% complete response rate at six months in BCG-unresponsive NMIBC

Protara reported interim ADVANCED-2 results showing a 68% complete response rate at six months in the BCG-unresponsive cohort and no Grade 3 or greater treatment-related adverse events; the company expects to complete enrollment of the BCG-unresponsive cohort in the second half of 2026.

Protara Therapeutics released updated interim results from its Phase 2 ADVANCED-2 trial of intravesical TARA-002 in patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, including both BCG-unresponsive and BCG-naïve cohorts. The company reported these data ahead of poster presentations at the American Society of Clinical Oncology Genitourinary Cancers Symposium, with a data cutoff of January 28, 2026. A conference call and webcast to review the results were scheduled by the company for the day after the release. Reported details: - The company reported a 68% complete response rate at six months in the BCG-unresponsive cohort, as stated in the release. - The interim BCG-unresponsive analysis included 35 evaluable participants, with 22 evaluable at six months and 15 evaluable at 12 months as of the data cutoff. - The interim BCG-naïve analysis included 29 evaluable participants, with 27 evaluable at six months and 19 evaluable at 12 months as of the data cutoff; enrollment in the BCG-naïve cohort is complete at 31 patients. - Safety was described as generally tolerable: most treatment-related adverse events were Grade 1 and transient, there were no Grade 3 or greater treatment-related adverse events reported by investigators, and no related serious adverse events or discontinuations due to treatment were reported. - The most commonly reported treatment-related adverse events were dysuria, bladder spasm, fatigue and urinary urgency, with most bladder irritations resolving shortly after administration or within a few hours to days. - Protara stated it expects to complete enrollment of the BCG-unresponsive registrational cohort of ADVANCED-2 in the second half of 2026 and to initiate the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of 2026. Summary: The interim ADVANCED-2 data reported by Protara indicate a 68% complete response rate at six months in the BCG-unresponsive cohort and a safety profile with no Grade 3 or greater treatment-related adverse events, as described in the release. Protara plans to present these results at the ASCO Genitourinary Cancers Symposium and expects to complete enrollment of the BCG-unresponsive registrational cohort in the second half of 2026; additional follow-up and registrational planning were described by the company.