CG Oncology Completes Enrollment in PIVOT-006

Rhea-AI Summary

CG Oncology (NASDAQ: CGON) has completed enrollment in its Phase 3 PIVOT-006 clinical trial, evaluating cretostimogene grenadenorepvec versus surveillance in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) patients. The study enrolled over 360 patients across 90+ sites, achieving completion nearly a year ahead of schedule.

The trial aims to address a significant unmet need, as IR NMIBC patients face recurrence rates of up to 70% with limited durable treatment options. Cretostimogene's novel approach works by selectively lysing tumor cells while activating anti-cancer immune responses, potentially offering a new treatment paradigm for bladder cancer patients.

Positive

• Rapid enrollment completed nearly one year ahead of schedule, indicating strong clinical interest
• Large-scale Phase 3 trial with over 360 patients across 90+ sites
• Addresses unmet need with no current FDA-approved options for IR NMIBC
• Novel dual mechanism of action: tumor cell lysis and immune response activation

Negative

• High recurrence rate of up to 70% in target patient population indicates challenging treatment landscape
• Open-label study design may introduce potential bias in results

Insights

Oncology Clinical Trial Expert

CG Oncology's faster-than-expected Phase 3 enrollment demonstrates strong clinical interest in cretostimogene for bladder cancer, signaling positive development momentum.

The rapid completion of enrollment in the PIVOT-006 Phase 3 trial represents a significant milestone for CG Oncology's lead candidate cretostimogene grenadenorepvec. With over 360 patients enrolled across 90+ sites nearly a year ahead of schedule, this demonstrates both strong investigator interest and patient need in the intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) space.

The clinical significance cannot be overstated. IR NMIBC patients face recurrence rates of up to 70% with limited durable treatment options. The study design comparing adjuvant intravesical cretostimogene versus surveillance following tumor removal addresses a critical gap in the treatment paradigm. Importantly, this represents one of the largest randomized Phase 3 studies in this specific patient population.

The mechanism of action - selectively lysing tumor cells while activating anti-cancer immune responses - offers a novel approach for this difficult-to-treat condition. If successful, this therapy would address an area with no current FDA-approved options for adjuvant IR NMIBC.

Accelerated enrollment timeframes in clinical trials often correlate with higher likelihood of regulatory submission, particularly when supported by a strong scientific rationale and unmet medical need. The company's strategic focus on expanding its addressable patient population beyond high-risk to include intermediate-risk NMIBC represents thoughtful pipeline development planning and potential market expansion.

– Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC) –
– One of the largest randomized phase 3 studies in this patient population will encompass broadest range of patient types per AUA/SUO Guidelines –

IRVINE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that it has completed enrollment in its Phase 3, randomized, open-label PIVOT-006 study comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance following bladder tumor removal in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).

“Intermediate-risk NMIBC presents a significant clinical challenge, with recurrence rates reaching up to 70% and few durable treatment options available to patients,” said Robert Svatek, M.D., MSCI, urologic oncologist at the Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center and global Principal Investigator for PIVOT-006. “Although it carries a lower risk of progression than high-risk disease, the relentless cycle of procedures and surveillance can diminish patients’ quality of life. There is growing enthusiasm within the urology community about the potential of cretostimogene in both intermediate- and high-risk NMIBC, underscored by the rapid enrollment of over 360 patients into the PIVOT-006 study across 90 plus sites. This unique therapy introduces a novel treatment paradigm—selectively lysing tumor cells while simultaneously activating a robust anti-cancer immune response.” 

“At CG Oncology, we remain steadfast in our mission to transform the treatment landscape for individuals living with bladder cancer,” said Vijay Kasturi, MD, Chief Medical Officer at CG Oncology. “Our clinical trial program is purposefully designed to address the full spectrum of disease stages and tumor types, with a particular focus on areas of high unmet need. We are especially encouraged by the strong interest and rapid enrollment, nearly a year ahead of schedule, in PIVOT-006 which highlights the urgent need for new treatment options in the intermediate-risk NMIBC population. This momentum reinforces our path toward a potential indication in adjuvant IR NMIBC, for which there are no U.S. FDA approved options. We are deeply grateful to the SUO-CTC for their support, to all participating trial sites for their dedication, and most importantly, to the patients who make this research possible.”

About PIVOT-006
PIVOT-006 is a Phase 3, randomized, open-label trial in intermediate-risk NMIBC comparing adjuvant intravesical cretostimogene grenadenorepvec to surveillance after bladder tumor removal. All participants undergo standard tumor removal, then are randomized to either receive cretostimogene instillations (weekly for 6 weeks, then weekly for 3 weeks every 3 months for one year) or surveillance. Control patients may switch to treatment if they relapse. To learn more about the study including eligibility requirements please visit: https://pivot006.com/.

About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.

Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; and the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
sarah.connors@cgoncology.com

Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com

FAQ

What is the significance of CG Oncology's PIVOT-006 trial completion?

The PIVOT-006 trial is one of the largest Phase 3 studies in intermediate-risk NMIBC, enrolling over 360 patients to evaluate cretostimogene grenadenorepvec versus surveillance. The rapid enrollment, completed nearly a year ahead of schedule, demonstrates significant unmet medical need.

How does cretostimogene grenadenorepvec work in bladder cancer treatment?

Cretostimogene grenadenorepvec works through a dual mechanism of action: it selectively lyses tumor cells while simultaneously activating an anti-cancer immune response, representing a novel treatment paradigm for bladder cancer.

What is the current recurrence rate for intermediate-risk NMIBC?

According to the trial information, intermediate-risk non-muscle invasive bladder cancer has a recurrence rate of up to 70%, with few durable treatment options available to patients.

How many patients and sites were involved in CGON's PIVOT-006 study?

The PIVOT-006 study enrolled over 360 patients across more than 90 clinical sites, making it one of the largest randomized Phase 3 studies in this patient population.

Are there currently any FDA-approved treatments for intermediate-risk NMIBC?

According to the press release, there are currently no U.S. FDA approved options for adjuvant treatment of intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).