CG Oncology CGON shares have rallied 26.5% in a month. This upsurge was observed after the company, in late April, announced superior efficacy data from some cohorts of a late-stage study of its investigational candidate, cretostimogene grenadenorepvec, which is being evaluated as a monotherapy for non-muscle invasive bladder cancer (NMIBC) patients.

Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy, which is being evaluated both as a monotherapy and in combinations across several mid- and late-stage studies for different bladder cancer indications.

CGON’s Phase III Bladder Cancer Study Results in Detail

The eligible patient population for CG Oncology’s phase III BOND-003 Cohort C study of cretostimogene included high-risk NMIBC patients who were unresponsive to Bacillus Calmette-Guérin (BCG) therapy and had carcinoma in situ (CIS), with or without concomitant Ta or T1 disease (papillary tumors).

As of the cut-off date of March 14, 2025, the data from the study showed a complete response (CR) rate of 75.5% at any time point, with 34 confirmed CRs at 24 months and nine patients still awaiting their 24-month assessment. Study results so far show a CR of 46.4% at 12 months and 33.7% at 24 months. The median duration of response was 28 months and continues to be sustained. Importantly, 97.3% of patients remained free from progression to muscle-invasive disease and 91.6% of responders remained cystectomy-free at 24 months.

Year to date, CGON shares have lost 8.6% compared with the industry’s 4.3% decline.

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CG Oncology also reported that in Cohort P of the BOND-003 study, which included patients with BCG-unresponsive Ta/T1 bladder cancer without CIS, cretostimogene achieved an estimated high-grade recurrence-free survival rate of 90.5% at both three and nine months among the 24 patients treated.

Despite being highly pre-treated, cretostimogene was well tolerated by the high-risk NMIBC patient population in the phase III BOND-003 Cohort C study. All treatment-related adverse events were mild to moderate. CG Oncology reported that 97.3% of patients completed all planned treatments, indicating strong adherence and compliance.

Based on such encouraging phase III results, management believes that cretostimogene has the potential to become a breakthrough backbone therapy in bladder cancer treatment.

CGON’s Competition in the NMIBC Space

CG Oncology faces significant rivalry from pharma bigwig, Johnson and Johnson JNJ, in the market for bladder cancer treatments. We remind the investors that in January 2025, J&J initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat the same NMIBC patient population as CGON’s cretostimogene. If approved, TAR-200 will be the first intravesical drug-releasing system in the given indication.