Protara Therapeutics announced positive results from its ongoing Phase 2 ADVANCED-2 trial, evaluating TARA-002 in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients. The investigational cell-based therapy demonstrated promising complete response rates in both Bacillus Calmette-Guérin (BCG)-unresponsive and BCG-naïve patients.
The open-label trial assessed intravesical TARA-002 in patients with carcinoma in situ (CIS) ± Ta/T1. Data, with a cutoff of November 19, 2024, included 20 patients evaluable at three months, 18 at six months, and three at nine months.
Complete Response Rates
The complete response (CR) rate across all BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time. Notably, 100% (9/9) of patients maintained a CR from three to six months, with two of three patients maintaining CR at nine months.
In the BCG-unresponsive cohort, the CR rate was 100% (4/4) at six months and 80% (4/5) at any time. The BCG-naïve cohort showed a CR rate of 64% (9/14) at six months and 67% (10/15) at any time.
Safety and Tolerability
TARA-002 exhibited a favorable safety profile. The majority of adverse events were Grade 1 and transient, with no Grade 2 or greater treatment-related adverse events (TRAEs). No patients discontinued treatment due to adverse events. Common adverse events included flu-like symptoms and urinary symptoms typical of urinary tract instrumentation.
Investigator Commentary
Brian Mazzarella, MD, Vice President of Research for Urology America and ADVANCED-2 study investigator, stated, "These impressive TARA-002 results demonstrate meaningful activity in a difficult to treat patient population. The activity of TARA-002 across BCG exposures, coupled with its ease of use and low procedural burden for physicians, make it an exciting potential treatment option for NMIBC patients."
Future Plans
Protara Therapeutics plans to report initial data from 12-month evaluable patients in mid-2025. The company believes the encouraging data and international site expansion will accelerate patient enrollment.
About TARA-002
TARA-002 is an investigational cell therapy developed from the same master cell bank as OK-432, an immunopotentiator marketed as Picibanil® in Japan. It is hypothesized to activate innate and adaptive immune cells, producing a pro-inflammatory response and directly killing tumor cells.
