Roger Li, MD, Talks Future Analyses of CG0070 Plus Pembrolizumab in BCG-Unresponsive NMIBC

Roger Li, MD, spoke about future trials planned for the combination of CG0070 plus pembrolizumab for patients with non–muscle invasive bladder cancer who were unresponsive to bacillus Calmette-Guerin.

At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork® spoke with Roger Li, MD, a genitourinary oncologist from Moffitt Cancer Center, about the future analyses planned for the phase 2 CORE1 trial (NCT04387461) which investigated CG0070, an oncolytic vaccine, plus pembrolizumab (Keytruda) as treatment for patients with non–muscle invasive bladder cancer who were unresponsive to bacillus Calmette-Guerin (BCG). Li also discusses what takeaways his colleagues should have from this presentation.


This is a phase 2 study and we have completed accrual with 35 patients thus far. We’re waiting for the data to mature to see what the complete response both at 3 months and 12 months are for all of the patients on the trial. Taking it to the next step, we will have to extend these results to a randomized control trial in which we’re comparing the efficacy of the combination to that of pembrolizumab alone. Pembrolizumab has been approved in the setting and it’s the only drug that’s been approved over the last 20 years or so.

We have hope in a very efficacious combination that’s safe for the patients with BCG-unresponsive [carcinoma in situ]–containing models in basic bladder cancer. Many of these patients will opt for bladder-preserving strategies rather than radical cystectomy for obvious reasons. Hopefully, with the maturing results from our current trial and also the next randomized control trial, we’ll be able to bring that to the patients soon.


Li R, Steinberg GD, Lamm D, et al. CORE1: Phase 2, single-arm study of CG0070 combined with pembrolizumab in patients with nonmuscle-invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette-Guerin (BCG). J Clin Oncol. 2022; 40(suppl 16):4597. Doi: 10.1200/JCO.2022.40.16_suppl.4597