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Thomas Flaig, MD


Oncolytic Vaccine Plus Pembrolizumab for BCG-Unresponsive Bladder Cancer

By: Julia Fiederlein Cipriano
Posted: Wednesday, May 17, 2023

According to Roger Li, MD, of the Moffitt Cancer Center, Tampa, and colleagues, combining the adenovirus CG0070 with pembrolizumab demonstrated “encouraging” safety and efficacy outcomes in patients with bacillus Calmette-Guérin (BCG)-unresponsive, non–muscle-invasive bladder cancer. The initial data from the phase II CORE1 trial were published in The Journal of Urology.

“CG0070 is…engineered to express granulocyte-macrophage colony-stimulating factor and replicate selectively in tumor cells with mutated or deficient [retinoblastoma tumor suppressor],” the investigators remarked. “The CG0070 mechanism of action includes cell lysis and immunogenic cell death, which is enhanced in the presence of granulocyte-macrophage colony-stimulating factor.”

According to the investigators, a total of 35 patients with BCG-unresponsive carcinoma in situ with or without concurrent stage Ta or T1 disease will be administered intravesical CG0070 in combination with 400 mg of intravenous pembrolizumab every 6 weeks; treatment with CG0070 will consist of six induction instillations per week, followed by three maintenance instillations per week at 3, 6, 9, 12, and 18 months. Patients who exhibit persistent carcinoma in situ or high-grade stage Ta disease at 3 months may receive six reinduction instillations of CG0070 per week. Pembrolizumab will be administered for up to 24 months.

The latest follow-up data revealed a 3-month complete response rate of 92% (n = 22 of 24). All of those who achieved a complete response at 3 months seemed to maintain it at downstream timepoints, with 14 of 16 patients at 6 months, 9 of 11 patients at 9 months, and 6 of 8 patients at 12 months continuing to demonstrate this degree of remission. The treatment-related adverse event profile was found to be consistent with those reported in prior studies of each agent alone.

“Data on efficacy and safety for all enrolled patients, as well as a biomarker assessment, [were] presented at the time of the [2023 American Urological Association (AUA) Annual Meeting (Abstract PD13-08)],” the investigators noted.

Disclosure: No disclosure information was provided.

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