The ADVANCED-2 trial, TARA-002

TARA-002 is a novel therapeutic agent currently being investigated for the treatment of non–muscle-invasive bladder cancer. It was evaluated in a phase 2 open-label clinical trial, where the agent—a lyophilized preparation of Streptococcus pyogenes—was delivered directly into the bladder through a catheter. The treatment concept mirrors that of BCG therapy, aiming to stimulate a local immune response within the bladder. Patients followed a regimen similar to BCG, receiving weekly doses over 6 weeks, with options for reinduction or maintenance based on individual response.

The trial involved 2 groups of patients: those who had never received BCG therapy (BCG naive) and those whose disease had not responded to it (BCG unresponsive). The BCG-naive group has completed enrollment, while the BCG-unresponsive cohort is still being enrolled. Early results from the trial are promising, especially in the difficult-to-treat BCG-unresponsive population, where high response rates were observed. The BCG-naive arm also demonstrated favorable outcomes, further supporting the potential of TARA-002 as an effective option.

This study holds particular significance given the current limitations in bladder cancer treatment. BCG shortages and varied patient responses to it have highlighted the need for alternative therapies. TARA-002 contributes to a growing arsenal of immunotherapy-based treatments that may offer more individualized and effective care. Expanding the range of available options is crucial not only for managing the disease more effectively but also for adapting to changing treatment landscapes and patient needs. This trial represents a valuable step toward broadening the therapeutic toolkit for bladder cancer.