TARA-002 Bladder Cancer Trial Readout: What The Interim Phase 2 Results Could Mean For BCG-Resistant Patients

Protara Therapeutics (TARA) is set to unveil fresh interim findings from its ADVANCED-2 trial at the Society of Urologic Oncology’s 26th Annual Meeting on December 4, 2025. The data will focus on Cohort A participants—specifically patients with carcinoma in situ (CIS) who either have never received BCG therapy or received it more than 24 months ago.

The Clinical Trial Landscape: Why This Matters

Non-muscle invasive bladder cancer (NMIBC) accounts for roughly 80% of all bladder cancer cases in the United States, with approximately 65,000 new diagnoses each year. Despite being the sixth most prevalent cancer in the country, treatment options for BCG-unresponsive and BCG-naïve patients remain limited, making TARA-002’s potential breakthrough significant for an underserved population.

TARA-002’s Mechanism and Study Design

The investigational cell-based therapy TARA-002 is being tested through intravesical administration—meaning direct delivery into the bladder. The ADVANCED-2 trial evaluates this approach in two distinct patient populations:

Cohort A encompasses patients with CIS who are either BCG-naïve (never previously treated) or BCG-exposed with a washout period exceeding 24 months since their last CIS diagnosis.

Cohort B includes those with persistent or recurrent CIS diagnosed within one year after completing adequate BCG therapy—the so-called BCG-unresponsive group.

What The Data Shows So Far

The upcoming December presentation will feature updated safety and efficacy metrics from 31 BCG-naïve enrolled participants, most of whom have now completed their six-month follow-up assessments.

From earlier ADVANCED-2 readouts released in April, the trial demonstrated compelling response rates. In BCG-unresponsive patients, TARA-002 achieved a complete response rate of 100% when measured at any point during observation, with 67% maintaining complete response at the 12-month mark. Among the BCG-naïve cohort, the therapy demonstrated a 76% complete response rate at any time point and a 43% response rate at 12 months.

Trial Protocol and Next Steps

Participants in the study received an induction phase consisting of six weekly intravesical TARA-002 instillations, with optional reinduction, followed by a maintenance regimen of three weekly doses administered every quarter.

Regulatory momentum appears to be building, with final data analysis and FDA discussions anticipated throughout 2026. The December 2025 interim data release represents a critical milestone in establishing the therapy’s profile in this challenging patient population.

Market Perspective

TARA shares have fluctuated between $2.21 and $10.48 over the past year, reflecting investor sentiment around the company’s clinical pipeline progress. The upcoming presentation will likely influence market perception of TARA-002’s competitive positioning in the bladder cancer treatment space.