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Study launches of pembrolizumab plus novel oncolytic immunotherapy in BCG-unresponsive NMIBC


The phase 2 study has a targeted enrollment of 37 patients and a primary end point of complete response.

The first patient has received treatment in the phase 2 CORE1 trial, which is investigating the combination of the PD-1 inhibitor pembrolizumab (Keytruda) with the investigational oncolytic immunotherapy CG0070 in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).1

The phase 2 study (NCT04387461) has a targeted enrollment of 37 patients. The primary end point is complete response rate at 12 months, with secondary end points including duration of response, overall survival, progression-free survival, and safety.

“We are motivated to advance this crucially important program, despite the challenges presented under the current global pandemic,” Arthur Kuan, CEO of CG Oncology, the developer of CG0070, stated in a press release. “CG0070, an oncolytic immunotherapy which has been administered to over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with Keytruda, which earlier this year was the first therapy in approximately 20 years approved for this indication.”

To enroll in the open-label, single-group assignment phase 2 CORE1 trial, patients must have pathologically confirmed NMIBC with carcinoma in situ (CIS; with or without Ta/T1 disease), have an ECOG performance status of 0 or 1, be unresponsive to BCG therapy, have adequate organ function, and be ineligible for or refuse radical cystectomy.

Patients are not eligible to enroll if they have had prior treatment with an adenovirus-based cancer therapy, have had prior therapy with and/or are intolerant to immune checkpoint inhibitor therapy, have clinically significant or active cardiac disease, or have active autoimmune disease.

The estimated primary completion date of the trial is December 2021.

Phase 2 study results for CG0070 monotherapy in patients with BCG-unresponsive NMIBC were shared at the 2018 American Urological Association Annual Meeting.2

The cohort included 67 patients with residual BCG-unresponsive high-grade Ta, T1, or CIS ± Ta/T1. All the patients in this study were unable to achieve disease-free state at 6 months after adequate BCG (BCG-refractory) or they developed recurrence after CR to BCG (BCG-relapsed).

Overall, treatment with CG0070 induced a CR rate of 30% at 12 months. In patients with BCG-refractory disease, the CR rate was 48%.

Pembrolizumab was approved by the FDA in January 2020 for the treatment of patients with BCG-unresponsive, high-risk, NMIBC with CIS with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.3

The approval was based on findings from the phase 2 KEYNOTE-057 trial, in which the PD-1 inhibitor elicited a CR rate of 41% in 96 patients with high-risk NMIBC with CIS with or without papillary tumors; the median duration of response was 16.2 months. Additionally, 46% of responding patients experienced a CR lasting ≥12 months.

Pembrolizumab has other FDA-approved indications in the first- and second-line settings for locally advanced or metastatic urothelial carcinoma.


1. CG Oncology Announces First Patient Dosed in Phase 2 Clinical Trial of CG0070, an Oncolytic Immunotherapy, in Combination with KEYTRUDA® (pembrolizumab) for Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin. Published online December 9, 2020. https://www.cgoncology.com/news/press-releases/120920. Accessed December 10, 2020.

2. Packiam VT, Barocas DA, Chamie K, et al. CG0070, An oncolytic adenovirus, for BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC): 12 month interim results from a multicenter phase II trial. Presented at: 2018 AUA Annual Meeting; May 18-21; San Francisco, CA. LBA24.

3. FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer [news release]. FDA. Published January 8, 2020. https://bit.ly/2tFigXZ. Accessed December 10, 2020.

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