Cretostimogene grenadenorepvec
Cretostimogene is a virus engineered to multiply only in bladder cancer cells with a broken RB pathway, instilled into the bladder. It cleared carcinoma in situ in 75% of BCG-unresponsive patients.
Replication restricted by the E2F-1 promoter to RB-deficient cells; expresses GM-CSF. BOND-003 cohort C: CR 75.2%, 24-month CR 41.8%, no grade 3+ treatment-related events. Rolling BLA under way; full submission expected Q4 2026. Also tested in BCG-naive (CORE-008) and intermediate-risk (PIVOT-006) NMIBC. CG Oncology.
1.Intravesical instillation after a surfactant (DDM) to loosen the urothelial barrier
- Route
- Intravesical
- Schedule
- Weekly ×6 induction, re-induction if needed, then maintenance every 3 months up to 3 years
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- 2026Filing / dealUS
Rolling BLA initiated; completion expected Q4 2026 source
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Bladder spasm | 20% | — |
| Urinary urgency | 18% | — |
| Grade 3+ treatment-related | — | 0% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
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