CG Oncology Announces First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-risk Non-Muscle Invasive Bladder Cancer
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Insights
The initiation of the PIVOT-006 Phase 3 clinical trial for cretostimogene in intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients represents a significant development in the field of oncology. NMIBC is a prevalent form of bladder cancer that, while not immediately life-threatening due to its non-invasive nature, poses a high risk of recurrence and progression to muscle-invasive disease. The current standard of care involves transurethral resection of the bladder tumor (TURBT) followed by intravesical therapy with Bacillus Calmette-Guérin (BCG), which has been in short supply and is typically reserved for high-risk cases.
Cretostimogene, as an oncolytic immunotherapy, leverages the ability of certain viruses to selectively infect and kill tumor cells while stimulating an immune response against the cancer. This dual mechanism could offer a more effective and bladder-sparing alternative to current treatments. If the trial's primary endpoint, overall recurrence-free survival (RFS), shows significant improvement over standard TURBT alone, it could lead to a new standard of care for patients with intermediate-risk NMIBC. However, it's important to monitor for potential side effects and long-term outcomes associated with this novel therapy.
From a research and development perspective, the PIVOT-006 trial is a critical step in the validation of cretostimogene's efficacy and safety. The trial's design, which includes a control arm receiving only the standard of care TURBT, allows for a direct comparison of outcomes. The use of overall RFS as the primary endpoint is a robust measure of the drug's potential to prevent disease recurrence, which is a significant burden for NMIBC patients. Secondary endpoints, such as RFS at 12 and 24 months and progression-free survival (PFS), will provide additional data points to assess the drug's performance over time.
Furthermore, the trial's open-label nature and the planned enrollment of 426 patients will likely provide a substantial dataset for statistical analysis. The trial's success could pave the way for regulatory approval and commercialization, which would have a notable impact on CG Oncology's business prospects and potentially its stock performance, contingent upon positive trial results and subsequent FDA approval.
From a market perspective, the advancement of cretostimogene into a Phase 3 trial addresses a significant unmet need in the NMIBC market, which is characterized by a high rate of recurrence and limited treatment options for intermediate-risk patients. The potential market for a bladder-sparing therapeutic is considerable, given the prevalence of NMIBC and the issues surrounding BCG availability. A successful trial could position CG Oncology as a leader in this space, potentially capturing a significant share of the market.
Investors and stakeholders should note that the outcome of this trial could have a substantial impact on the company's valuation. A positive result may lead to increased investor confidence and a rise in stock value, while a negative outcome could have the opposite effect. It is also essential to consider the competitive landscape, as other companies may be developing similar therapies that could impact cretostimogene's market potential. Nonetheless, the initiation of the PIVOT-006 trial is a pivotal moment for CG Oncology and its investors.
- PIVOT-006 Phase 3 open-label trial of adjuvant cretostimogene is CG Oncology’s earliest disease stage clinical trial for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) -
- Primary endpoint of PIVOT-006 Phase 3 clinical trial is overall recurrence-free survival (RFS), with secondary endpoints including RFS at 12 and 24 months and progression-free survival (PFS) -
IRVINE, Calif., Feb. 27, 2024 (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 afflicted with bladder cancer, today announced the first patient has been dosed in the PIVOT-006 Phase 3 clinical trial of cretostimogene for the treatment of patients with intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT).
“The dosing of the first patient in our PIVOT-006 trial advances cretostimogene earlier in the treatment paradigm for NMIBC patients who face limited treatment options, frequent disease recurrence and repetitive surgery,” said Arthur Kuan, Chairman and Chief Executive Officer, CG Oncology. “Intermediate-risk NMIBC patients face a difficult combination of disease characterized by tumor recurrence and a shortage of BCG therapy which is often reserved for use only in high-risk patients, limiting treatment options for intermediate-risk patients. Our goal with the PIVOT-006 trial is to advance cretostimogene as a potential backbone oncolytic immunotherapy.”
PIVOT-006 is a Phase 3, open-label, two-arm trial enrolling up to 426 intermediate-risk NMIBC patients, one arm to be administered cretostimogene following the standard of care TURBT with the second arm receiving the standard of care TURBT only. The initial induction course is six weekly doses of cretostimogene containing 1x1012 VPs per milliliter. Patients who are recurrence free at month three will receive a maintenance course involving three weekly cretostimogene doses administered at the same dose, in months 3 and 6, followed by single weekly doses in months 9 and 12. The primary endpoint of this trial is overall RFS, with secondary endpoints including RFS at 12 and 24 months and PFS.
“I am excited to see the PIVOT-006 study get underway in the intermediate-risk NMIBC population with cretostimogene, a highly selective oncolytic immunotherapy,” said Neal D. Shore, MD, FACS, the Medical Director for the Carolina Urologic Research Center in Myrtle Beach, South Carolina. “Novel treatment options and clinical trials are essential in NMIBC, particularly in this group of underserved patients who undergo considerable follow up and have limited intravesical therapeutic options. Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer.”
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Cretostimogene is also being evaluated in a Phase 2 clinical trial (CORE-001) in combination with pembrolizumab in the same indication and in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.
About the PIVOT-006 Clinical Study
PIVOT-006 (NCT06111235) is a Phase 3, open-label, two-arm monotherapy study enrolling 426 patients and evaluating adjuvant cretostimogene in intermediate-risk NMIBC patients following transurethral resection of the bladder tumor (TURBT). The primary endpoint of PIVOT-006 is overall recurrence-free survival (RFS), with secondary endpoints including RFS at 12 and 24 months and progression-free survival.
About Bladder Cancer
More than 83,000 people are estimated to be diagnosed with bladder cancer in 2024. NMIBC is the most common form of bladder cancer, representing approximately
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, the potential therapeutic benefits of cretostimogene for intermediate-risk NMIBC patients and other disease states. 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: potential delays in the commencement, enrollment and completion of clinical trials, including enrollment in the PIVOT-006 trial; 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; unfavorable results from clinical trials; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; regulatory developments in the United States and foreign countries; and other risks described in our filings with the SEC, including under the heading “Risk Factors” in the final prospectus dated January 24, 2024 we filed with the SEC and any subsequent filings with the SEC. 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
Investor Relations
Bing Kung
CG Oncology
IR@cgoncology.com
Media
Kimberly Ha
KKH Advisors
(917) 291-5744
kimberly.ha@kkhadvisors.com
FAQ
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