On May 1, 2023 CG Oncology, Inc. announced updated data from the CORE-001 study, an ongoing Phase 2 clinical trial of cretostimogene grenadenorepvec (CG0070) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, MAY 1, 2023, View Source [SID1234630801]).

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The results were presented by Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center in an oral presentation at the American Urological Association (AUA) 2023 Annual Meeting in Chicago, IL.

"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, Chief Executive Officer, CG Oncology. "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."

Summary of New Clinical Results

Abstract #23-5631 – CORE-001: Phase 2 Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (BCG)

The new data for CORE-001 adds to data previously presented and shows anti-tumor activity, tolerability and durability of cretostimogene grenadenorepvec in combination with pembrolizumab for patients with BCG unresponsive NMIBC.

Based on a preliminary data cutoff on March 3, 2023, 34 patients were evaluable for efficacy with a minimum of 3-month follow up.
85% of patients evaluable for efficacy (n=29/34) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 82% (n=27/33) have also maintained a CR through 6 months, 81% (n=25/31) through 9 months and 68% (n=17/25) at the 12-month assessment.
The combination of cretostimogene grenadenorepvec and pembrolizumab has been generally well tolerated with the adverse event profile consistent with that observed in prior studies of each agent alone. The most common treatment-related adverse events reported include transient grade 1-2 local genitourinary symptoms.
"We are excited to see the responses at 12 months for the majority of the trial patients," said Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center. "We plan to follow the patients in complete remission beyond this time point to ascertain longer-term response to cretostimogene grenadenorepvec and pembrolizumab."

About the CORE-001 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of cretostimogene grenadenorepvec in combination with pembrolizumab, CORE-001, which has completed enrollment of 35 total patients, evaluates the safety and efficacy of cretostimogene grenadenorepvec plus pembrolizumab for the treatment of BCG-Unresponsive NMIBC.

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.

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec (CG0070) is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).