CG Oncology Reveals Promising Results from Phase II CORE-001 Clinical Trial for the Treatment of BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer


Results from the CORE-001 clinical trial are expected to be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.

Prostate disease, Benign prostatic hyperplasia (BPH), Prostate cancer. 3d illustration. Image Credit: Adobe Stock Images/Crystal light

Image Credit: Adobe Stock Images/Crystal light

CG Oncology announced positive final results from its Phase II CORE-001 clinical trial of cretostimogene grenadenorepvec (an oncolytic immunotherapy) in combination with pembrolizumab for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS). Results indicated that at one year, the complete response (CR) rate was 57%, moving to 54% after two years. Additionally, the duration of response exceeded 21 months but hasn’t been fully reached. After two years, there was no progression to muscle-invasive cancer or metastatic disease, with 80% of patients also experiencing cystectomy-free survival.1

“There is a significant unmet need for new and innovative treatments for patients suffering with bladder cancer. We are encouraged by the final safety and efficacy data from our CORE-001 Phase 2 trial which showed a class-leading complete response (CR) and duration of response (DoR) compared to existing FDA-approved therapies and other investigational candidates,” said Vijay Kasturi, MD, chief medical officer, CG Oncology, in a press release. “We look forward to sharing these data at ASCO, as they reinforce the potential use of cretostimogene as a bladder-sparing backbone therapy for NMIBC, which is generally well tolerated by patients, either as monotherapy or in combination. Additionally, we believe these results support further investigation of cretostimogene in combination with checkpoint inhibitors and we plan to incorporate these findings into our planned CORE-008 trial in high-risk NMIBC.”

In 2023, CG Oncology announced an earlier data update from the CORE-001 study, which discovered that 34 patients were evaluable for efficacy with a minimum of a three month follow up. Further, 85% of these patients achieved a CR at the time of follow up, and 82% also maintained it for six months, 81% at nine months, and 68% after a year.2

“The latest results from the CORE-001 trial continue to demonstrate strong efficacy and a favorable safety profile for cretostimogene grenadenorepvec in BCG-Unresponsive NMIBC, a difficult-to-treat patient population,” said Arthur Kuan, CEO, CG Oncology, in a press release. “We hope that the clinical evidence from our combination study with Keytruda will demonstrate cretostimogene grenadenorepvec’s potential to become a foundational bladder-sparing therapy for patients who have limited options.”

According to the American Cancer Society (ACS), bladder cancer accounts for around 4% of all cancer in the United States and is more common in men. For 2024, ACS estimates that there are close to 83,190 new cases of bladder cancer. A majority of individuals with bladder cancer are first diagnosed over the age of 55. However, rates of bladder cancer have been declining in recent years.3

“About half of all bladder cancers are first found while the cancer is still only in the inner layer of the bladder wall,” reports ACS. “These are non-invasive or in situ cancers. About 1 in 3 bladder cancers have spread into deeper layers of the bladder wall but are still only in the bladder. In most of the remaining cases, the cancer has spread to nearby tissues or lymph nodes outside the bladder. Rarely (in about 5% of cases), it has spread to distant parts of the body when it is first found.”


1. CG Oncology to Present Positive Final Results from Phase 2 CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive High-Risk NMIBC at ASCO 2024 Annual Meeting. CG Oncology. May 24, 2024. Accessed May 28, 2024.

2. CG Oncology Announces New Phase 2 Data with Cretostimogene Grenadenorepvec (CG0070) in Combination with KEYTRUDA® (pembrolizumab) in BCG-Unresponsive NMIBC. BusinessWire. May 1, 2023. Accessed May 28, 2024.

3. Key Statistics for Bladder Cancer. American Cancer Society. Accessed May 28, 2024.

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