CG Oncology (NASDAQ:CGON) executives used an RBC Capital Markets fireside chat to outline recent clinical data for cretostimogene, the company’s investigational therapy for non-muscle invasive bladder cancer, and to discuss upcoming regulatory, manufacturing and commercial milestones.
The discussion, hosted by Leo Timashev, director and biotechnology equity research analyst at RBC Capital Markets, focused first on newly presented Cohort CX data evaluating cretostimogene in combination with gemcitabine. CG Oncology said the data, presented at the American Urological Association meeting in Washington, D.C., were intended to assess efficacy, safety and dosing schedules in BCG-exposed and BCG-unresponsive patients.
Cohort CX Data Showed Combination Signal
CG Oncology said Cohort CX included both concurrent dosing, with cretostimogene followed by gemcitabine on the same day, and sequential dosing, with two weeks of cretostimogene followed by gemcitabine in week three. The company said both approaches appeared safe and showed relatively similar efficacy in the six-month data presented.
From an efficacy standpoint, the company said the combination showed “high relative efficacy” compared with prior data sets it has shared, including a complete response at any time that was about 15 percentage points higher. About two-thirds of patients in the trial were BCG-exposed, while the remaining third were BCG-unresponsive.
CG Oncology said the positive signal could help inform the design of a future randomized Phase 3 trial in BCG-exposed patients. The company described that group as an underserved population of roughly 50,000 patients, including patients who did not receive adequate BCG or were beyond a defined time period from their last BCG treatment.
The company also highlighted the safety profile of the combination, saying it had not observed grade 3 or higher side effects in the data set so far. CG Oncology contrasted that with prior combination work involving pembrolizumab, where it said many side effects were related to the immunotherapy component.
PIVOT-006 Readout Expected in Coming Months
CG Oncology also discussed PIVOT-006, its trial of cretostimogene versus standard-of-care TURBT in intermediate-risk non-muscle invasive bladder cancer. The company said the study is designed to pursue what it described as the broadest label in intermediate-risk NMIBC under AUA/SUO guidelines.
The company reiterated that data from PIVOT-006 are expected “in the coming months,” while noting that the trial is event-driven, making precise timing difficult to predict. CG Oncology said the study enrolled about a year ahead of schedule, which affected prior estimates around the readout timeline.
On effect size, CG Oncology said it has publicly discussed a hazard ratio of 0.7. The company also said the ATLAS trial, which showed 50% at 12 months, may serve as a useful reference point. However, CG Oncology said physicians are generally focused less on the exact hazard ratio and more on whether the therapy works, how long it works and what side effects it carries.
CG Oncology said it believes it is more than 15 to 18 months ahead of competitors in the intermediate-risk NMIBC setting and sees an opportunity to create a new market for cretostimogene, where it said there is no branded product with the broad label it is pursuing.
Company Positions Cretostimogene as Backbone Therapy
CG Oncology said its broader goal is to establish cretostimogene as a “backbone therapy” across multiple NMIBC segments. The company cited data or ongoing work in BCG-unresponsive, high-risk, BCG-naive, BCG-exposed and intermediate-risk settings.
In discussing the competitive landscape, CG Oncology said NMIBC should be viewed by specific disease segment rather than as one crowded market. The company identified potential patient populations of about 50,000 in intermediate-risk NMIBC, 25,000 in BCG-unresponsive disease, 50,000 in BCG-exposed disease and 25,000 in BCG-naive disease.
The company also addressed questions about mechanism of action, saying cretostimogene has a dual mechanism involving direct tumor lysis followed by immune activation that can lead to adaptive memory response. CG Oncology said RB mutation is one factor in high-risk disease but not the only driver of response. It also pointed to prior Cohort P data in Ta/T1 papillary-only disease as providing confidence for the intermediate-risk setting.
Regulatory Filing and Manufacturing Plans
On manufacturing, CG Oncology said its clinical and commercial scales are the same for the first indication, which it described as an important distinction from situations where companies must scale from clinical supply to commercial production. The company said its current scale provides capacity of about 50,000 vials for the first indication and has been used to treat more than 700 patients across clinical trials.
CG Oncology said it has completed the clinical and non-clinical portions of its rolling biologics license application and has one remaining module, the CMC package. The company said it plans to complete the filing by the end of this year, specifically in the fourth quarter.
The company said work is ongoing at its Biovire fill-and-finish facility, which it purchased last summer. CG Oncology said upgrades include quality management system improvements, a shift from paper-based to electronic systems, added staffing and mock inspections across its network of partners in preparation for a CBER inspection.
CG Oncology said filings for additional indications will be sequential. The company said it plans to file for intermediate-risk disease in 2027 after the first filing is completed, with the later filing expected to share the same CMC and non-clinical packages while using different clinical data.
Launch Preparation Underway
CG Oncology said it has been working on pre-launch activities for about a year and a half. The company said medical science liaisons are already in the field, health systems directors have been engaging large-volume centers and account executives have begun discussions with payers.
The company said it is recruiting sales leadership and expects a launch footprint of about 75 individuals, including reimbursement support. CG Oncology said it is also building hub services and reimbursement support services as part of launch readiness.
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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