(RTTNews) - Protara Therapeutics, Inc. (TARA) has reported new interim results from Cohort A of its ongoing Phase 2 ADVANCED-2 trial of TARA-002 in BCG- naïve patients with high-grade non-muscle invasive bladder cancer (NMIBC).
The updated data were presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in Phoenix, Arizona.
Bladder cancer is the sixth most common cancer in the U.S., with NMIBC representing about 80% of diagnoses. Approximately 65,000 patients are diagnosed with NMIBC annually in the U.S.
ADVANCED-2 is a Phase 2 open-label study evaluating the safety and anti-tumor activity of intravesical TARA-002 in adults with carcinoma in situ CIS ± Ta/T1 disease.
The trial includes two cohorts:
- Cohort A: CIS patients who are BCG- naive or BCG-exposed but untreated for at least 24 months. - Cohort B: CIS patients who are BCG-unresponsive within 12 months of adequate BCG therapy.
Patients received an induction course of six weekly intravesical instillations of TARA-002, followed by maintenance courses of three weekly instillations every three months. Re-induction was permitted for eligible patients with residual CIS or recurrent high-grade Ta disease.
In the updated dataset, TARA-002 demonstrated encouraging efficacy in BCG- naïve patients. The complete response (CR) rate was 72% at any time, with 69% of patients maintaining CR at six months and 50% at twelve months.
Durability of response was notable, as 88% of initial responders sustained CR through six months and all evaluable patients maintained CR through twelve months. Re-induction therapy also proved beneficial, with 80% of re-treated patients converting to CR at six months, with all of those responders maintaining CR at twelve months.
Safety remained favorable, with most treatment related adverse events (TRAEs) being Grade 1 and transient. No Grade 3 or higher TRAEs were reported, and no patients discontinued due to adverse events. The most common TRAEs were dysuria (13%), fatigue (13%), and hematuria (6%).
The company remains on track to report interim results from approximately 25 six-months evaluable BCG-unresponsive patients in the registrational cohort of the ADVANCED-2 trial in Q1 2026.
Enrollment of this cohort is expected to be completed in the second half of 2026.
Protara has received written FDA feedback supporting a registrational design for a controlled trial in BCG-naïve patients, with intravesical chemotherapy as the comparator. The FDA agreed on CR at 6 months as the primary end point and duration of response as a key secondary end point.
TARA is currently trading at $6.78, up 8.98%. Over the past 12 months the stock has traded between $2.77 and $10.48.
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