Cretostimogene monotherapy demonstrated 75.2% complete response rate in high-risk, BCG-unresponsive non-muscle invasive bladder cancer. CG Oncology.

These data were featured at the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology Plenary Session as an oral presentation (Abstract #24-11358) by Dr. Mark D. Tyson, Urologic Oncologist at Mayo Clinic, at the 2024 American Urological Association (AUA) Annual Meeting, in San Antonio, TX.

In addition, cretostimogene has shown durable responses over time with twenty-nine patients maintaining a complete response for 12 months or more, pending evaluation and assessment of ongoing responses in twenty-two patients as of the data cutoff. Median duration of response (DOR) was not reached. 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.

Cretostimogene is an investigational oncolytic immunotherapy which has shown selective oncolysis and potent anti-tumor immune response, and is being evaluated in BOND-003 (NCT04452591), a single-arm, Phase III, monotherapy clinical trial for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in-situ (CIS) with or without Ta or T1 papillary tumors.

The fully enrolled global trial with a total of 112 patients is currently ongoing in North America and the Asia-Pacific region. The primary endpoint of the study is CR at any time, with DOR measured as a secondary endpoint. The highly pre-treated study population includes patients with prior intravesical chemotherapy and systemic immunotherapy.

There were no Grade 3 or higher treatment-related adverse events (TRAEs) or deaths reported, and two patients (1.8%) had serious TRAEs (Grade 2). No treatment-related discontinuation of cretostimogene was observed. 94.5% of patients completed all expected treatments. TRAEs occurred in 70 patients (62.5%). The most common TRAEs ( greater than 10%) were bladder spasm, pollakiuria, dysuria, micturition urgency, and hematuria, as of the safety cutoff date of January 31, 2024.

“The positive 12-month BOND-003 data presented at AUA 2024, with a notable duration of response, reinforces cretostimogene monotherapy as a potential backbone therapy in the NMIBC treatment landscape for BCG-unresponsive patients. This innovative immunotherapy candidate may, if approved, emerge as a favored option for patients over the surgical extraction of their bladder, as they face limited options,” said Gary D. Steinberg, M.D., Professor, Department of Urology at Rush University Medical Center. “Cretostimogene reported remarkable interim efficacy results, with over half of the patients experiencing complete responses upon repeat induction. There continues to be a need for new options for patients with bladder cancer.”

Last December, the FDA granted both Fast Track Designation and Breakthrough Therapy Designation for cretostimogene in high-risk BCG-unresponsive NMIBC with carcinoma in-situ with or without Ta or T1 papillary tumors.