CG Oncology announced an expedited timeline for the topline data readout for the Phase 3 PIVOT-006 clinical trial.
The topline data is now expected in the first half of 2026 for evaluating cretostimogene monotherapy in intermediate-risk NMIBC.
PIVOT-006 is the first Phase 3 randomized trial in this patient population with over 90 sites participating.
Topline Data Expectation
Phase 3 topline data for PIVOT-006 expected in the first half of 2026, nearly one year ahead of schedule.
Investigational Therapy
PIVOT-006 is the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC.
Population Impact
The IR patient population is estimated to be greater than fifty thousand patients in the United States.
- The expedited timeline of topline data indicates significant progress in the Phase 3 clinical trial for intermediate-risk NMIBC.
- Broad participation across academic and community sites highlights the trial's real-world relevance and potential impact on patients with IR NMIBC.
CG Oncology's accelerated timeline for PIVOT-006 Phase 3 data shows promising developments in the evaluation of cretostimogene monotherapy for intermediate-risk NMIBC patients.