Roger Li, MD, Examines the Safety Profile of CG0070 Plus Pembrolizumab in BCG-Unresponsive NMIBC

Roger Li, MD, spoke about the safety profile of CG0070 plus pembrolizumab for patients with non–muscle invasive bladder cancer.

CancerNetwork® spoke with Roger Li, MD, a genitourinary oncologist from the Moffitt Cancer Center, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting about the safety profile of CG0070, an oncolytic vaccine, in combination with pembrolizumab (Keytruda) which was examined in the phase 2 CORE1 trial (NCT04387461) for patients with non–muscle invasive bladder cancer who were unresponsive to bacillus Calmette-Guerin (BCG). The most common treatment-emergent adverse effects (TRAEs) of any grade in 18 patients assessed were bladder spasm and pollakiuria in 7 patients each, fatigue in 6 patients, and dysuria in 5.


It’s a very nontoxic and tolerable treatment regimen. Many of the adverse events [AEs] that we saw on trial were, not surprisingly, bladder-related symptoms like bladder spasms, frequency, urination, and sometimes blood in the urine, [known as] hematuria. Outside of that [there were] few immune-related adverse events. There were a few patients that we saw with autoimmune thyroiditis that were very easily treated with thyroid supplements. We haven’t observed, at least as of now, any severe immune-related adverse events.


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