Cretostimogene grenadenorepvec delivered durable efficacy in BCG-unresponsive, non–muscle-invasive bladder cancer, with Phase 3 BOND-003 Cohort C results in The Lancet Oncology showing complete responses in 75% of patients. In the single-arm study, efficacy exceeded a historical benchmark of 20%, with many responses maintained through 24 months. Across 115 enrolled patients, 83 of 110 assessed patients achieved complete response at any time after a median follow-up of 25.8 months. Notably, 14 complete responses occurred after re-induction, and 46% of patients remained in complete response at 12 months; 42% were still in complete response at 24 months. Adverse events were predominantly mild and transient, supporting continued dosing strategies that included weekly intravesical induction for 6 weeks followed by optional re-induction and maintenance for those achieving complete response. The randomized benchmarks for NMIBC in this setting remain limited, making the centrally confirmed complete-response endpoint especially relevant for regulatory and clinical adoption.
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