Posted: Tuesday, May 10, 2022
A phase III study is currently testing CG0070, a serotype 5 adenovirus that induces expression of granulocyte macrophage–colony stimulating factor in cells, as a therapy for patients with bacillus Calmette-Guérin (BCG) unresponsive non–muscle-invasive bladder cancer. CG0070 previously yielded a response rate of 45% in patients with recurrent non–muscle-invasive bladder cancer after BCG. The methods for this study were presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract CT233/4) by Edward Uchio, MD, of the University of California, Irvine.
This study will enroll 110 patients with BCG-unresponsive carcinoma in situ of the bladder. Patients will be treated with intravesicular CG0070 at a dose of 1 x 1012 viral particles. Patients will receive induction therapy weekly for 6 weeks followed by three weekly maintenance doses at months 3, 6, 9, 12, and 18. Those with persistent carcinoma in situ or high-grade tumors at 3 months may undergo induction therapy for a second time. Researchers will monitor response to treatment using cystoscopy every 3 months, with biopsy of areas that are suspicious for disease. In addition, patients will be monitored using urine cytology, imaging, and bladder mapping at 12 months.
The primary endpoint of this study will be a complete response as determined by the methods previously described. Other endpoints will be a complete response at 12 months, the duration of response, progression-free survival, cystectomy-free survival, and safety. Correlative assessments within this study will include changes to the tumor microenvironment, systemic immune induction assessed by peripheral blood and urine samples, plus viral replication and transgene expression. The baseline expression of the coxsackie adenovirus receptor, the E2F transcription factor, and an antiadenovirus antibody titer will also be correlated with tumor response.
Disclosure: For a full list of authors’ disclosures, visit abstractsonline.com.