Protara Therapeutics is set to present new interim data from its Phase 2 ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) at the Society of Urologic Oncology (SUO) 25th Annual Meeting, held December 4-6, 2024, in Dallas, Texas. The data, which includes updated safety and new efficacy findings from approximately 20 enrolled patients, offers a look into the potential of TARA-002 as a treatment for this common form of bladder cancer.
ADVANCED-2 Trial Details
The ADVANCED-2 trial (NCT05951179) is an open-label Phase 2 study evaluating intravesical TARA-002 in NMIBC patients with carcinoma in situ (CIS) with or without Ta/T1 disease. The trial includes both Bacillus Calmette-Guérin (BCG)-unresponsive and BCG-naïve patients, with a target enrollment of over 100 patients in the BCG-unresponsive cohort and 27 in the BCG-naïve cohort. The BCG-Unresponsive cohort is designed to be registrational, aligning with the FDA's guidance on developing treatments for this condition.
TARA-002 Mechanism of Action
TARA-002 is an investigational cell therapy derived from the same master cell bank as OK-432 (Picibanil), an immunopotentiator approved in Japan and Taiwan. It is hypothesized that TARA-002 activates innate and adaptive immune cells within the bladder tumor, leading to a pro-inflammatory response and the release of cytokines such as TNF-alpha, IFN-gamma, IL-6, IL-10, and IL-12. Additionally, TARA-002 is believed to directly kill tumor cells and induce immunogenic cell death, further enhancing the antitumor immune response.
Bladder Cancer Context
Bladder cancer is the sixth most common cancer in the United States, with NMIBC accounting for approximately 80% of diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is characterized by cancer found in the tissue lining the inner surface of the bladder that has not spread into the bladder muscle.
Presentation at SUO
The poster presentation at SUO, titled "ADVANCED-2: Phase 2 Open-Label Study to Evaluate Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer," will take place on December 5, 2024, from 1:15 p.m. to 2:15 p.m. CT.
