Roger Li, MD, shares the results of the phase 2 CORE1 clinical trial, which evaluated CG0070 in combination with pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer.
Roger Li, MD, a genitourinary oncologist at Moffitt Cancer Center, shares the results of the phase 2 CORE1 clinical trial (NCT04387461), which evaluated CG0070 in combination with pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
In prior studies of single-agent CG0070, the selective oncolytic immunotherapy achieved at 12-month complete response (CR) rate of roughly 30%, according to Li.
In 2020, pembrolizumab was granted FDA approval for the treatment of BCG-unresponsive, high-risk, NMIBC with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. The immune checkpoint inhibitor had demonstrated a CR rate of 41% in the phase 2 KEYNOTE057 clinical trial (NCT02625961).
Li et al hypothesized the CG0070 and pembrolizumab would be synergistic and the CORE1 study showed CRs in 20 out of 22 patients.
0:08 | Previously, CG0070 has been tested as a monotherapy in a phase 1 trial as well as in a phase 2 trial that demonstrated the 12-month CR rate of the monotherapy agent was around just under 30%. And as you know, immunotherapy has also overtaken the treatment of BCG-unresponsive disease in that pembrolizumab was recently approved for that setting.
0:36 | So, we hypothesize that the 2 can be placed together for synergistic efficacy. And what we've seen in our preliminary results from the court to trial reflects exactly that. That in the first 22 patients that were treated on trial 20 patients had obtained a complete response and have those patients reach the 12-month mark, 8 patients that reached that time point, and 6 of those 8 had continued to have a durable response.