Protara Therapeutics Inc. (NASDAQ:TARA) reported updated 12-month Phase 2 data for TARA-002 in patients with Bacillus Calmette-Guérin (BCG)-naïve non-muscle invasive bladder cancer (NMIBC), highlighting durable complete response rates and a favorable safety profile.
The updated findings from Cohort A of the ongoing open-label ADVANCED-2 study were presented during a poster session at the American Urological Association 2026 Annual Meeting.
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Durable Responses Observed At 12 Months
The dataset included 31 BCG-naïve NMIBC patients, with 29 evaluable for efficacy as of the April 5, 2026, data cutoff.
The company said the complete response (CR) rate at any time reached 72.4%, with 21 of 29 patients responding to treatment.
At six months, the CR rate stood at 66.7% among 27 evaluable patients. At 12 months, 55% of 20 evaluable patients maintained a complete response.
Among responders, the Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1%, with a 95% confidence interval of 52.9 to 93.4.
The company also noted that 91.7% of patients maintained their complete response from nine months through 12 months. In addition, four of six re-induced patients achieved a complete response at six months.
Investigators Highlight Safety Profile
Mark Tyson, professor of urology at Mayo Clinic Phoenix and an investigator in the ADVANCED-2 study, said the data demonstrated strong durability and a favorable safety profile for TARA-002 in BCG-naïve NMIBC patients.
Tyson added that the bladder cancer community continues to need effective bladder-sparing treatment options, while also pointing to the therapy's streamlined administration process for physicians and patients.
According to the company, most treatment-related adverse events were Grade 1 and transient. No Grade 3 or higher treatment-related adverse events were reported, and no patients discontinued treatment because of side effects.
The most commonly reported treatment-related adverse events included dysuria, fatigue and hematuria.
Protara Eyes Registrational Study Expansion
Jesse Shefferman, CEO of Protara Therapeutics, said the latest results reinforced the company's belief in TARA-002's potential in BCG-naïve NMIBC.
Shefferman added that Protara plans to complete enrollment in the registrational BCG-unresponsive cohort of ADVANCED-2 and expects to initiate ADVANCED-3, a registrational study comparing TARA-002 with intravesical chemotherapy, in the second half of 2026.
TARA Price Action: Protara Therapeutics shares were down 3.77% at $5.09 at the time of publication on Friday, according to Benzinga Pro.
Over the past month, TARA has declined about 1.92% versus a 6.3% rise in the S&P 500 and is down roughly 4% year-to-date compared to the index’s 7.8% gain.
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