The authors investigate the tolerability and efficacy of VPM1002BC, a recombinant BCG strain with enhanced immunogenicity, in patients with BCG failure. The BCG strain was administered at conventional BCG induction and maintenance schedules with up to 1 year of maintenance. 40 patients were included, all with high-grade tumors. The rate of CIS was high (68%). RFS at the planned interim analysis of 60 months was 49% [95% CI 32-64 months]. The intravesical treatment was generally well tolerated, with only 5% of patients unable to tolerate adequate induction therapy. It would be interesting to subanalyze responses in the subset of patients who meet the FDA definition for BCG unresponsive disease, as this has implications in single-arm registration trials.
Presented by: Cyrill Rentsch, MD, Ph.D., The University Hospital Basel Department of Urology, Switzerland
Written by: Dr. Patrick Hensley, Urologic Oncology Fellow at MD Anderson Cancer Center, Twitter: @pjhensley11, with Ashish Kamat, MD, MBBS, President of The International Bladder Cancer Network (IBCN), The International Bladder Cancer Group (IBCG), and Professor of the Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, Twitter: @UroDocAsh, at the International Bladder Cancer Network (IBCN) Annual Meeting, #IBCN2020, October 17, 2020.