CG Oncology reports best-in-disease durability data for cretostimogene at AUA 2025

How is CG Oncology reshaping bladder cancer therapy with Cretostimogene?

CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company, announced highly encouraging 24-month durability results for its investigational therapy, cretostimogene grenadenorepvec. The updated Phase 3 BOND-003 Cohort C data, presented at the 2025 American Urological Association (AUA) Annual Meeting, revealed best-in-disease durability outcomes for patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy. An early positive signal from Cohort P further expanded optimism about cretostimogene’s potential across a broader range of NMIBC patient profiles.

Highlights included a 24-month complete response rate of 42.3% by Kaplan-Meier (K-M) estimation in Cohort C and a 90.5% high-grade recurrence-free survival at 3 and 9 months in Cohort P. The results position cretostimogene as a strong contender to become a backbone therapy in bladder cancer treatment strategies.

What were the major findings from BOND-003 Cohort C?

The Phase 3 BOND-003 Cohort C study enrolled 110 efficacy-evaluable patients diagnosed with BCG-unresponsive high-risk NMIBC, with carcinoma in situ (CIS) either alone or in combination with Ta or T1 disease. These patients were heavily pretreated, having received a median of 12 prior BCG doses, with some receiving as many as 66. Additional prior treatments included intravesical chemotherapy for 41.1% of patients and systemic immunotherapy for 6.3%.

Despite this challenging background, cretostimogene demonstrated robust clinical efficacy. Complete response at any time was observed in 75.5% of patients. By K-M estimation, 50.7% of patients achieved complete response at 12 months, and 42.3% maintained their response at 24 months. The median duration of response was reported as 28 months and remains ongoing.

Importantly, 97.3% of treated patients remained free from progression to muscle-invasive bladder cancer (MIBC) at the two-year mark, while 91.6% of complete responders were able to avoid cystectomy. No Grade 3 or greater treatment-related adverse events (TRAEs) or deaths were reported, reinforcing the therapy’s favorable safety profile.

How promising are the early results from Cohort P?

Alongside the data from Cohort C, CG Oncology unveiled initial findings from Cohort P, which focuses on patients with BCG-unresponsive Ta/T1 disease without CIS. In this group, cretostimogene achieved a 90.5% high-grade recurrence-free survival rate at both three and nine months, based on Kaplan-Meier estimates.

The safety profile in Cohort P mirrored that seen in Cohort C, with no severe treatment-related adverse events reported. The rapid resolution of mild adverse events further supports cretostimogene’s potential to deliver effective, tolerable therapy across different high-risk NMIBC subgroups.

What insights did clinical experts share about Cretostimogene’s potential?

Gary D. Steinberg, M.D., Professor in the Department of Urology at Rush University Medical Center, noted that cretostimogene continued to demonstrate strong safety and efficacy even among heavily pretreated high-risk NMIBC patients. He stated that Cohort P results highlighted cretostimogene’s broad applicability and further validated its dual mechanism of action as a critical differentiator in treating bladder cancer.

Ambaw Bellete, President and Chief Operating Officer of CG Oncology, emphasized that cretostimogene’s strong clinical performance, durable response rates, and bladder-sparing potential could offer significant advantages over existing NMIBC treatments. He indicated that ongoing monotherapy studies, as well as combination trials, could help address the substantial unmet need among bladder cancer patients worldwide.

What makes Cretostimogene different from existing bladder cancer therapies?

Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy developed to selectively destroy cancer cells while stimulating an immune response against bladder tumors. Unlike BCG, which often loses efficacy after repeated exposure, cretostimogene’s dual mechanism is designed to maintain therapeutic potency even in patients who have undergone extensive prior treatment.

The treatment has demonstrated favorable tolerability across more than 400 patients involved in Phase 2 and Phase 3 trials, including BOND-003 and PIVOT-006. No Grade 3 or greater TRAEs have been reported, and the therapy has shown high rates of treatment completion, reinforcing its potential role as a bladder-sparing alternative for patients otherwise facing radical surgery.

How is CG Oncology’s stock performance and investor sentiment shaping up after the BOND-003 update?

Following the announcement of its 24-month durability data, CG Oncology, Inc.’s stock (NASDAQ: CGON) posted a gain of approximately 2.4% during after-hours trading. The stock movement reflected positive investor sentiment driven by the strong clinical results and the therapy’s potential commercial opportunity.

Analyst coverage remains largely favorable, with most firms maintaining Buy ratings. Analysts cite cretostimogene’s sustained response rates, the absence of disease progression to muscle-invasive stages, and a favorable safety profile as key differentiators within the competitive NMIBC therapeutic landscape.

Institutional investor activity remains supportive. Recent regulatory filings indicate that healthcare-specialized and growth-oriented funds have maintained or modestly increased their positions in CG Oncology following the data release. No significant institutional selling has been observed, suggesting strong medium- to long-term confidence.

While foreign institutional investor (FII) and domestic institutional investor (DII) activity metrics are less applicable for a U.S.-listed biotech company, CG Oncology continues to attract attention from global healthcare investment funds. The durability of response and bladder-sparing benefits showcased in the BOND-003 results are seen as key factors driving continued institutional interest.

Looking forward, investors are monitoring potential regulatory milestones, upcoming data from the PIVOT-006 trial in intermediate-risk NMIBC, and future updates related to combination therapy studies. Expert sentiment favors a Buy outlook for medium- to long-term investors willing to navigate the risks typically associated with late-stage biopharmaceutical companies.

A potential breakthrough for high-risk NMIBC treatment

CG Oncology’s 24-month data from the Phase 3 BOND-003 study marks a significant advance in the treatment of high-risk NMIBC. With durable complete response rates, a strong bladder-sparing profile, and favorable safety outcomes, cretostimogene grenadenorepvec is positioned as a potential backbone therapy for patients unresponsive to BCG. As the company advances toward regulatory interactions and prepares for broader clinical deployment, CG Oncology’s trajectory suggests it may play a leading role in reshaping the bladder cancer treatment landscape.