– 54% complete response (CR) rate in the intention-to-treat population at 24-month landmark and meets primary endpoint of the phase 2 study
Reno, Nevada (UroToday.com) -- 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 the publication in Nature Medicine of final results from the Company’s CORE-001 Phase 2 trial of cretostimogene plus pembrolizumab in BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NIMBC). The article, titled “Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial” is now available online and will be published in a future print issue of Nature Medicine. The most recent data cut as of May 17, 2024, was also featured as a poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
"The CORE-001 trial results published in Nature Medicine clearly demonstrate the potential for cretostimogene to be used as a bladder-sparing backbone therapy for NMIBC,” said Vijay Kasturi, MD, Chief Medical Officer, CG Oncology. “We are honored that Nature Medicine and ASCO are publishing our compelling safety and efficacy phase 2 study results, which showed a class-leading complete response (CR) and duration of response (DoR) compared to existing FDA-approved therapies and other investigational candidates.”
“As a principal investigator on both the BOND-003 Phase 3 monotherapy clinical trial as well as the CORE-001 Phase 2 combination trial it is especially gratifying to see the studies culminating in such strong results,” said Roger Li, M.D., urologic oncologist at Moffitt Cancer Center. “These data highlight the promise of cretostimogene’s novel mechanism of action, providing both direct tumor cell kill while activating an anti-tumor immune response. I believe cretostimogene as an oncolytic immunotherapy has the potential to act as the backbone to multiple treatment strategies in the new bladder sparing paradigm in bladder cancer management.”
As previously shared in the Company’s May 24th press release, the CORE-001 Final Results are as follows:
- As of the data cutoff on February 5, 2024, the CR rate in the intention-to-treat (ITT) population at 12-months and any time, was 57% (20/35) [95% confidence interval (CI), 40-73%] and 83% (29/35) (95% CI, 70-95%), respectively. As of May 17, 2024, the CR rate in the ITT population at 24 months was 54% (19/35) (95% CI, 37-71%).
- Of the patients in a CR at 12 months, 95% of patients (19/20) maintained a CR for another 12 months.
- Median DoR has not been reached but exceeds 21 months.
- Additionally, the Kaplan-Meier estimates for CR rate at 12- and 24 months were 77.3% (95% CI, 58.1-88.5%) and 69.6% (95% CI, 49.4-83.0%), respectively.
- Progression-free survival (PFS) at 24 months is 100% with no patients progressing to muscle invasive cancer or metastatic disease; Cystectomy-free survival (CFS) at 24 months was 80%; for patients in CR, CFS at 24 months was 100%.
- Treatment-related adverse events (TRAEs) were consistent with the individual agents and demonstrate no synergistic toxicity. Results to be presented are an update from previously reported data in the abstract.
The Phase 2 CORE-001 trial was conducted in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The combination of cretostimogene and pembrolizumab received FDA Breakthrough Therapy Designation in May 2023.
Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in BCG-Unresponsive, HR-NMIBC with CIS in December 2023. CG Oncology recently presented data from the Phase 3 BOND-003 trial at the 2024 American Urological Association Annual Meeting which showed sustained durable responses over 12 months and a 75.2% complete response rate at any time. Topline data from BOND-003 is expected by the end of 2024, and the Company is on track for a regulatory approval submission. To learn more about the results from BOND-003 you may read the Company’s press release issued on May 3, 2024.
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 patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy.
Cretostimogene is also being evaluated 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.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About the CORE-001 Study
CORE-001 was a Phase 2 single-arm, open-label clinical trial of cretostimogene administered in 35 patients with high-risk, BCG-unresponsive NMIBC that have carcinoma in situ-containing tumors, in combination with pembrolizumab, following disease resection. CORE-001 was conducted pursuant to a clinical collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). More information about the study, CORE-001 (NCT04387461), along with other studies sponsored by CG Oncology, can be found at www.clinicaltrials.gov or www.cgoncology.com.
Source: CG Oncology. (2024) CG Oncology Announces Nature Medicine Publication of Final Results from CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive NMIBC [Press release] https://ir.cgoncology.com/news-releases/news-release-details/cg-oncology-announces-nature-medicine-publication-final-results
Related Content:
ASCO 2024: Final Results of CORE-001: A Phase-2, Single Arm Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in Patients with BCG-Unresponsive, Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ
Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial
CORE-001 Study: Promising Results for Bladder Cancer with Cretostimogene Grenadenorepvec and Pembrolizumab - Trinity Bivalacqua & Roger Li