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Thomas Flaig, MD


SITC 2022: Phase II Trial Update on Vaccine Plus Pembrolizumab in Resistant Bladder Cancer

By: Sarah Lynch
Posted: Monday, November 14, 2022

Researchers are conducting a phase II trial on the use of CG0070, an oncolytic vaccine, and intravenous pembrolizumab in the treatment of bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer. At the initial 3-month timepoint, 88% of patients evaluable for efficacy (n = 28 of 32) have achieved a complete response.; of those evaluable for complete response, 88% have maintained that response through 6 months; 86%, through 9 months; and 73%, through 12 months. These findings were reported at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 666).

“With a unique dual mechanism of action that first engages an immune response and then amplifies that response with immune checkpoint blockade, this novel combination of CG0070 with pembrolizumab could potentially change the outlook for patients with BCG-unresponsive bladder cancer,” said Roger Li, MD, of the Moffitt Cancer Center and Research Institute, Tampa, in a press release.

During the study, 35 patients with BCG-unresponsive carcinoma in situ were treated with intravesical CG0070 and pembrolizumab. The vaccine was administered six times a week as induction followed by thrice-weekly maintenance installations at months 3, 6, 9, 12, and 18. Pembrolizumab was administered for up to 24 months. The assessment of collected data included cystoscopies with biopsies of areas suspicious of disease every 3 months, urine cytology, CT/MR urography, and bladder-mapping biopsies after 12 months.

Based on follow-up data, the combination therapy has been found to be generally well tolerated, with an adverse event profile consistent with that reported in prior studies of each agent alone. The most common treatment-related adverse events reported with the novel therapeutic regimen include grade 1 or 2 local genitourinary symptoms.

Disclosure: No information regarding conflicts of interest was provided.

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