Executives from CG Oncology (NASDAQ:CGON) outlined clinical results, ongoing trials, and launch preparations for its investigational intravesical therapy cretostimogene (referred to as “Credo”) during a recent company event, emphasizing response durability in high-risk non–muscle invasive bladder cancer (NMIBC) and a broad development program spanning multiple NMIBC settings.
Mechanism and administration designed for urology workflow
The company described Credo’s proposed mechanism as selective viral killing that may release cytokines and tumor-associated antigens, which management said could help prime an antitumor immune response. The speakers linked this proposed immune priming to the “long tail” of responses the company says it has observed in its clinical studies.
BOND-003 Cohort C data highlighted for planned FDA submission
CG Oncology said Cohort C of the BOND-003 trial is the first cohort it plans to submit to the FDA, describing it as a BCG-unresponsive CIS (carcinoma in situ) cohort. The company reported:
- A complete response (CR) rate “at any time” of 75.5% in over 110 patients.
- An observed 12-month CR rate of 46.4%.
- From 12 months to 24 months, the company said roughly 90% of patients who were in CR at 12 months remained in CR at two years.
Management compared that durability with other therapies, stating that “Keytruda only has a 9% CR rate at 2 years.” The speakers also said they have not seen any grade 3 adverse events related to the drug in this cohort, calling the profile compelling for patients seeking bladder preservation.
Additional cohorts: papillary disease, BCG-naive, and combination work
The company discussed other ongoing and planned readouts across its program:
BOND-003 Cohort P (papillary disease without CIS): In this cohort, tumors are resected at baseline and Credo is given as adjuvant therapy. Management said results are still early but “trending in the right direction,” with additional 12-month data and beyond expected later this year. The company said this population is expected to support guideline-related efforts over time.
CORE-008 Cohort A (BCG-naive): CG Oncology said the aim is to show Credo can work in BCG-naive disease, while acknowledging that BCG performs well in that setting. The company highlighted an 88% complete response rate in an “optimized installation cohort,” describing it as encouraging and supportive of Credo as a potential backbone therapy.
Credo plus gemcitabine (combination study): The company said it is evaluating Credo in combination with another intravesically delivered agent, noting that while prior Credo plus pembrolizumab (“Pembro”) improved response by about 10 percentage points, pembrolizumab is not typically administered by urologists day-to-day. Based on preclinical findings suggesting synergy, the company is studying Credo with gemcitabine and expects early data in the first half of this year. In discussion of the Cohort CX dataset, management said the study includes both BCG-exposed and BCG-unresponsive patients, with an expected initial disclosure focused on event-free survival and CR rate in the CIS population; durability would be addressed later. The company said about 50 patients have been enrolled.
PIVOT-006 intermediate-risk trial: design and expectations
CG Oncology described PIVOT-006 as a key focus and positioned it as an adjuvant study in intermediate-risk (IR) NMIBC, where management said there is currently no FDA-approved adjuvant therapy. The company said it followed AUA/SUO guidelines and emphasized a design feature it called differentiating: it is “the only company” including high-grade Ta solitary lesions under 3 cm.
The primary endpoint is recurrence-free survival (RFS). Management said the trial covers newly diagnosed and recurrent patients, includes high-grade Ta patients, and has no restrictions related to FGFR mutation status. They also highlighted that the trial permits a single-dose perioperative chemotherapy, noting that in the U.S. an estimated 30% to 40% of patients receive a single dose of chemotherapy and that PIVOT-006 stratifies for that variable.
On upcoming top-line disclosure, executives said the primary endpoint readout would include a hazard ratio and median follow-up, while 12-month landmark data (a key secondary endpoint) and 24-month RFS would come later. In framing expectations, management referenced control-arm performance from the ATLAS trial (which they noted did not complete and was underpowered), citing about 50% RFS around 15 months in the TURBT-only control arm. They also said clinicians may view a 30% relative risk reduction as clinically meaningful.
Regarding timing, the company said PIVOT-006 last patient in was in September and guided that an intermediate-risk filing would be expected in 2027, after the BCG-unresponsive submission is completed, while noting that the two filings would share the same CMC package.
BLA timing, manufacturing focus, and commercial build
On regulatory timing, management said it has already initiated the BLA submission process for the BCG-unresponsive high-risk indication and expects to complete the filing in 2026, with more guidance to come on timing and module submissions. Executives said the remaining work to complete the BLA is primarily related to CMC, particularly facility-related process validation, with specific attention on fill-finish and the higher standard expected when moving from clinical to commercial manufacturing. They also cited ongoing dialogue with the FDA following the agency’s announcement of greater flexibility for cell and gene therapy CMC submissions and process validation steps.
Commercially, the company said it has been in pre-launch mode for more than 15 months. Executives said medical science liaisons are calling on key accounts and health systems directors are profiling large customers, while a national accounts team is engaging payers and monitoring utilization management dynamics. The company described the market as concentrated, citing factors including a long-running BCG shortage and private equity-driven consolidation of urology practices, mentioning Cardinal Health as a large owner of LUGPA. Management said about 300 accounts could represent more than 70% of the business in the targeted setting.
The company said it is building toward a launch organization expected to include around 75 to 80 individuals, including field reimbursement staff, regional business directors, and key account managers. Executives also said they have been studying the TAR-200 launch as a “proxy,” focusing on who adopts first, purchasing channels, and how long formulary adoption can take at academic centers (citing a range of six to eight months or longer).
In closing remarks, management reiterated near-term catalysts for the year, including completion of the BLA filing and additional data readouts such as PIVOT-006 top-line data and combination data from Credo plus gemcitabine cohorts.
About CG Oncology (NASDAQ:CGON)
CG Oncology, Inc (NASDAQ: CGON) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibody-based immunotherapies for the treatment of solid tumor cancers. The company leverages a platform-driven approach to identify and optimize antibody candidates that engage key immune checkpoints and co-stimulatory pathways within the tumor microenvironment. Its pipeline encompasses multiple preclinical programs alongside early-phase clinical trials designed to assess safety, dosing and preliminary anti-tumor activity.
Headquartered in South San Francisco, California, CG Oncology conducts clinical research primarily in the United States, collaborating with leading academic medical centers and contract research organizations to advance its lead candidates.
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