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CG Oncology Announces Publication of Pivotal Phase 3 BOND-003 Cohort C Study Results in The Lancet Oncology

CGON
  • CG Oncology announced the publication of Phase 3 BOND-003 Cohort C trial results evaluating cretostimogene grenadenorepvec monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ in The Lancet Oncology.
  • The trial met its primary endpoint with a complete response rate of 75.5% at any time.
  • Median duration of response was at least 27.9 months, with approximately 89% of patients maintaining their bladders at 12 months & 81% at 24 months.
  • Progression to muscle-invasive bladder cancer occurred in only 3.4% of patients over the study period.
  • The treatment demonstrated a favorable safety profile with no Grade 3 or greater treatment-related adverse events, discontinuations, or deaths reported.
  • Common treatment-related adverse events included bladder spasm, pollakiuria, micturition urgency, dysuria, & hematuria.
  • Cretostimogene administration is practical & office-based, requiring no prophylactic medication, operating room time, or anesthesia.
  • The study enrolled 112 patients across North America, Australia, & the Asia-Pacific region who had previously received therapies such as intravesical gemcitabine–docetaxel or systemic pembrolizumab.
  • Cretostimogene has received FDA Fast Track & Breakthrough Therapy designations & is currently being studied in additional trials including PIVOT-006 & CORE-008.
  • The full manuscript titled "Intravesical cretostimogene grenadenorepvec oncolytic immunotherapy in high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ (BOND-003 Cohort C): a single-arm, phase 3 trial" is available in The Lancet Oncology.