Dr Li on the Use of CG0070 Plus Pembrolizumab in BCG-Unresponsive Non–muscle Invasive Bladder Cancer

Roger Li, MD, genitourinary oncologist, Moffitt Cancer Center, discusses phase 2 data with the combination of CG0070 (cretostimogene grenadenorepvec) and pembrolizumab (Keytruda) in patients with non–muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG).

The phase 2 CORE-001 trial (NCT04387461) has fully accrued a total of 35 patients with BCG-unresponsive carcinoma in situ (CIS)–containing NMIBC, and 25 patients had 12-month response data available at the time of data cutoff, Li says. The primary end point of the trial was the 12-month complete response (CR) rate evaluated with random bladder biopsies, cystoscopy, and urine cytology. Results showed that 68% of patients achieved a CR at 1 year, demonstrating the durability of response with the combination, Li says. Additionally, there was little additive toxicity with the addition of CG0070. Notably, immune-related adverse effects were transient and resolved after treatment completion.

Both pembrolizumab and nadofaragene firadenovec-vncg (Adstiladrin) are approved for the treatment of adult patients with high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumors. However, the 1-year CR rates with these agents range from 20% to 25%, leaving most patients vulnerable to disease recurrence and need for subsequent therapy, Li explains. As such, the CR rate reported in this trial is encouraging and worthy of further exploration, according to Li.

To that end, investigators will continue to follow patients in 6-month intervals after year 2. Moreover, the single-arm phase 3 BOND-003 trial (NCT04452591) has been launched, and will investigate CG0070 monotherapy in 110 patients with high-risk, BCG-unresponsive, CIS-containing NMIBC. The primary end point of this trial is CR at any time. Additionally, the phase 3 PIVOT-001 trial is planning to evaluate CG0070 in combination with checkpoint inhibition in the same population.