{"entity":{"id":"cretostimogene","kind":"drug","name":"Cretostimogene grenadenorepvec","aka":[],"tldr":"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.","summary":"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.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04452591 (BOND-003)","url":"https://clinicaltrials.gov/study/NCT04452591"}],"tags":[],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["oncolytic-virus","bcg-and-intravesical-therapy"],"targets":[],"drugs":[],"companies":["cg-oncology"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":["bond-003","nct07283835","nct06111235","nct06567743"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"CG0070","modality":"Oncolytic adenovirus (intravesical)","mechanism":"Conditionally replicating adenovirus lyses RB-pathway-defective tumour cells and secretes GM-CSF to recruit antigen-presenting cells.","approvals":[],"mechanismSteps":["Intravesical instillation after a surfactant (DDM) to loosen the urothelial barrier","Adenovirus enters cells; E2F-1 promoter allows replication only where RB is inactivated","Lysis releases tumour antigens; encoded GM-CSF recruits dendritic cells","Systemic anti-tumour immunity contributes to durable complete responses"],"dosing":{"route":"Intravesical","schedule":"Weekly ×6 induction, re-induction if needed, then maintenance every 3 months up to 3 years"},"toxicity":[{"event":"Bladder spasm","anyGradePct":20},{"event":"Urinary urgency","anyGradePct":18},{"event":"Grade 3+ treatment-related","grade3PlusPct":0}],"access":[],"regulatoryEvents":[{"date":"2026","type":"filing","region":"US","note":"Rolling BLA initiated; completion expected Q4 2026","source":"https://cgoncology.com/cg-oncology-reports-first-quarter-2026-financial-results-and-provides-business-updates-2/"}]},"route":"/drugs/cretostimogene/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"technology":[{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"},{"id":"oncolytic-virus","kind":"technology","name":"Oncolytic viruses","route":"/technologies/oncolytic-virus/"}],"company":[{"id":"cg-oncology","kind":"company","name":"CG Oncology","route":"/companies/cg-oncology/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"}],"trial":[{"id":"nct06111235","kind":"trial","name":"A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT","route":"/trials/nct06111235/"},{"id":"bond-003","kind":"trial","name":"BOND-003","route":"/trials/bond-003/"},{"id":"nct06567743","kind":"trial","name":"Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC","route":"/trials/nct06567743/"},{"id":"nct07283835","kind":"trial","name":"Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin","route":"/trials/nct07283835/"}],"idea":[{"id":"idea-bio2-oncolytic-regulated-il12","kind":"idea","name":"Oncolytic viruses that make interleukin-12 only inside the tumour","route":"/ideas/idea-bio2-oncolytic-regulated-il12/"}]}}