On April 13, 2022 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported that interim results from the global Phase 2 study (CORE1) of 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, APR 13, 2022, View Source [SID1234612165]).

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The interim Phase 2 results showed that the combination of CG0070 and pembrolizumab was well tolerated with encouraging early efficacy data in 18 patients. The results (Session CT036) were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.

"These interim results continue to support CG0070’s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population," said Arthur Kuan, Chief Executive Officer, CG Oncology. "As the study nears conclusion, we hope to see continued positive results for CG0070 in combination with pembrolizumab as well as durability in patients who have limited treatment options."

Summary of Interim Clinical Results

As of the interim analysis, based on a data cutoff on April 7, 2022, 18 patients were evaluable for efficacy.
89% of patients evaluable for efficacy (n=18) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 85% (n=13) have also maintained a CR through 6 months, 78% (n=9) through 9 months and 75% (n=8) at the 12-month assessment.
Treatment related adverse events (AEs) were generally limited to transient grade 1-2 local genitourinary symptoms and immune-related adverse events including pollakiuria, bladder spasm, dysuria, fatigue, nocturia, hematuria, chills, autoimmune thyroiditis and hypothyroidism. No treatment-related grade 3 or higher AEs or severe adverse events (SAEs) have been observed.
"These interim results continue to be potentially game changing in patients who are often reluctant to undergo radical surgery for non-invasive bladder cancer," said Dr. Edward Uchio, M.D., study investigator and Urologic Oncologist at UCI Medical Center. "CG0070, which has been administered in over 150 patients to date, exhibits a dual mechanism of action shown to be highly clinically meaningful in bladder cancer."

About the CORE1 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CG0700

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in NMIBC following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.