TAR-200, a novel sustained-release drug delivery system, achieved 82% complete response rates in patients with high-risk non-muscle-invasive bladder cancer that had failed standard BCG immunotherapy. This represents the most effective treatment reported to date for this patient population, offering a bladder-sparing alternative to radical cystectomy.
Study Design & Population
- Study Type: Phase 2 clinical trial (SunRISe-1)
- Sample Size: 85 patients across 144 global locations
- Patient Population: High-risk non-muscle-invasive bladder cancer with BCG-unresponsive disease
- Treatment Protocol: TAR-200 administered every 3 weeks for 6 months, then quarterly for 2 years
Key Findings
- Primary Endpoint: Complete response in 70 of 85 patients (82%)
- Durability: Cancer remained absent in nearly 50% of patients at 12 months
- Response Timeline: Majority of responses achieved within 3 months of treatment initiation
- Safety Profile: Well-tolerated with minimal side effects
- Combination Therapy: TAR-200 plus cetrelimab showed inferior efficacy and increased toxicity compared to TAR-200 monotherapy
Clinical Implications
- Provides bladder-sparing treatment option for patients previously facing radical cystectomy
- Establishes new standard of care consideration for BCG-unresponsive disease
- Demonstrates superiority of sustained drug release over traditional intravesical instillations
- FDA Priority Review status suggests potential near-term availability
Limitations
- Single-arm design without direct comparison to radical cystectomy
- Limited long-term follow-up data beyond 12 months
- Unclear patient selection criteria for optimal outcomes
- Cost-effectiveness compared to surgical intervention not assessed
Source: https://news.keckmedicine.org/new-treatment-eliminates-bladder-cancer-in-82-of-patients/
