High Complete Response and Durability in TAR-200 SunRISe-1 Cohort 2

Published

July 22, 2025

Author

Lansbury Sinclair

Lansbury is an intelligence analyst focused on immunology. She tracks clinical and market developments across psoriasis, psoriatic arthritis, and lupus.

The Phase 2b SunRISe-1 trial presented compelling findings at the 2024 ESMO Congress, showcasing TAR-200’s notable effectiveness as monotherapy for patients with high-risk, non-muscle invasive bladder cancer (HR-NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Out of the studied cohort, TAR-200 achieved a remarkable complete response (CR) rate of 83.5%, substantially surpassing previously available therapies. Significantly, the durability of the therapeutic effect was equally impressive, with 82% of responders maintaining remission at 9 months, and an estimated 12-month complete response rate of 57%. This indicates a robust and lasting impact on disease management. The safety profile further strengthened TAR-200's clinical appeal, demonstrating a low incidence (9%) of Grade ≥3 treatment-related adverse events (TRAEs), minimal treatment discontinuation (6%), and no treatment-related fatalities. Such outcomes significantly enhance TAR-200’s position as a promising therapeutic option, potentially transforming patient management paradigms in HR-NMIBC.

Citation: Johnson & Johnson Investor Report, 2024. Available at: https://www.investor.jnj.com

Implication: TAR-200’s strong efficacy and excellent safety profile could significantly alter standard treatment protocols, providing clinicians with a reliable new therapy.