Roger Li, MD, Reviews Efficacy of CG0070 Plus Pembrolizumab for BCG-Unresponsive NMIBC

Roger Li, MD, spoke about responses from the CORE1 trial that examined patients with non–muscle invasive bladder cancer treated with CG0070 plus pembrolizumab.

Roger Li, MD, a genitourinary oncologist from the Moffitt Cancer Center, spoke with CancerNetwork® at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting about the results of the phase 2 CORE1 trial (NCT04452591) which looked at CG0070, an oncolytic vaccine, plus pembrolizumab (Keytruda) for patients with non–muscle invasive bladder cancer who were unresponsive to bacillus Calmette-Guerin (BCG).1 The primary end point of the trial was the complete response (CR) rate which was 92% overall. Drilling down by timepoint, the CR rate at 6 months was 88%, at 9 months it was 82%, and at 12 months it was 75%.


The CR rate, which is our primary end point for the CORE1 trial, is set at the 12-month mark. Because these patients have a non–muscle invasive recurrence, the gold standard treatment is radical cystectomy which is the removal of the bladder. It’s a very morbid procedure and is completely life-altering for many patients. In addition, there are many patients who are elderly and frail and cannot undergo the procedure. It’s important for us to use salvage therapy to help patients preserve their bladders. Because of that, we’re looking at long-term CR rates so that we not only get a CR up front, but we help patients preserve their bladders for the long term. We use the 12-month mark and CR rate as the primary end point. Six out of 8 patients who have reached that time point continue to have a CR.

In the past in the [phase 2] KEYNOTE-057 trial [NCT02625961], which used pembrolizumab as the treatment agent for a similar cohort of patients, the 3-month CR rate was 41%.2 In comparison, ours is over 90%. So, 22 of 24 patients did derive a CR at the 3-month mark from our trial. [This is] encouraging both in the early time point CR rate, as well as at the 12-month mark.


  1. 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
  2. Balar AV, Kamat AM, Kulkarni GS, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Published correction appears in Lancet Oncol. 2021 Aug;22(8):e347]. Lancet Oncol. 2021;22(7):919-930. doi:10.1016/S1470-2045(21)00147-9