NEW YORK, May 15, 2026
Protara Therapeutics, Inc. announced positive updated 12-month data from the fully enrolled BCG-Naïve cohort of its ongoing Phase 2 ADVANCED-2 trial evaluating TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC). The latest results demonstrated a 72% complete response (CR) rate at any time, a 67% CR rate at six months, and a 55% CR rate at the 12-month landmark, reinforcing the therapy’s potential as a durable bladder-sparing treatment option for high-risk NMIBC patients. The data were presented during a poster session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.
TARA-002 Shows Durable Responses in Bladder Cancer Patients
The updated efficacy analysis included 31 BCG-Naïve NMIBC patients, with 29 evaluable for efficacy, 27 evaluable at six months, and 20 evaluable at the 12-month analysis cutoff dated April 5, 2026. Investigators reported that 21 of 29 patients achieved a complete response, while the majority of responders maintained durable responses throughout the study period. Among patients who responded to treatment, the estimated probability of maintaining a complete response for six months reached 73.1%, highlighting the durability of TARA-002 therapy in a difficult-to-treat cancer setting.
Importantly, 91.7% of patients maintained their complete response from nine to 12 months, while patients who underwent reinduction therapy also demonstrated encouraging outcomes, with 66.7% converting to complete responses at six months. These findings position TARA-002 competitively among both approved therapies and investigational treatments currently under development for high-risk bladder cancer.
Mark Tyson, M.D., Professor of Urology at Mayo Clinic Phoenix and an ADVANCED-2 study investigator, stated that the NMIBC community continues to face a major unmet need for effective and bladder-preserving therapies. He emphasized that the durability data and favorable safety profile support the potential of TARA-002 as a meaningful treatment option for BCG-Naïve patients.
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Favorable Safety Profile Strengthens Clinical Potential
Beyond efficacy, TARA-002 demonstrated a highly encouraging safety and tolerability profile throughout the study. Investigators reported that the majority of treatment-related adverse events were Grade 1 and transient, with no Grade 3 or greater treatment-related adverse events observed. Additionally, no patients discontinued therapy due to treatment-related adverse effects, a significant advantage in the NMIBC treatment landscape where tolerability often impacts long-term treatment adherence.
The most commonly reported treatment-related adverse events included dysuria, fatigue, and hematuria, all of which were considered manageable. The company noted that the therapy’s favorable safety profile, combined with streamlined intravesical administration, could simplify treatment delivery for both physicians and patients.
TARA-002 is an investigational cell-based immunopotentiator therapy derived from inactivated Streptococcus pyogenes. The therapy activates both innate and adaptive immune pathways within the bladder wall, stimulating the release of inflammatory cytokines including TNF-alpha, IFN-gamma, IL-6, IL-10, and IL-12 while also directly triggering tumor cell death and enhanced antitumor immune responses.
Protara Advances Toward Registrational Development
Protara confirmed it remains on track to initiate the ADVANCED-3 registrational trial in the second half of 2026. The upcoming study is expected to compare TARA-002 with intravesical chemotherapy in BCG-Naïve and potentially BCG-Exposed NMIBC patients. The company is also continuing enrollment in the BCG-Unresponsive cohort of ADVANCED-2.
Bladder cancer remains the sixth most common cancer in the United States, with NMIBC accounting for nearly 80% of all bladder cancer diagnoses, affecting approximately 65,000 patients annually in the U.S. alone. The strong clinical data generated by TARA-002 may help address the growing demand for safer and more effective bladder-preserving therapies for high-risk NMIBC patients.
Source: Protara Therapeutics press release
