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Thomas Powles, MD, MBBS, MRCP, discusses the implications of data from sasanlimab plus BCG in patients with BCG-naive, high-risk NMIBC.
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“There are patients with urothelial cancer who come into harm’s way, even in non–muscle-invasive disease, with local or metastatic relapse. Preventing [relapse] is important and [sasanlimab plus BCG] will be an attractive option for some of those patients.”
Thomas Powles, MD, MBBS, MRCP, a professor of genitourinary oncology and director of Barts Cancer Centre at St. Bartholomew’s Hospital, Queen Mary University of London, discussed the clinical implications of data from the phase 3 CREST study (NCT04165317) of sasanlimab plus BCG in patients with BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC).
Immune checkpoint inhibitors (ICIs) such as sasanlimab have been shown to be less effective later in the disease course of NMIBC, especially in patients with metastatic disease that has spread to many sites, Powles began. As therapies in this class have been moved into earlier lines of treatment for patients with NMIBC, efficacy outcomes such as event-free survival (EFS) have shown encouraging signals, he continued. From an efficacy standpoint, the biological characteristics of the disease could make earlier lines of treatment with ICIs more feasible, he added.
However, many patients with NMIBC can have their disease cured with surgery alone and there is the potential for overtreatment, Powles explained. There are patients with NMIBC who experience local or metastatic disease relapse and sasanlimab plus BCG represents an attractive option for some of those patients, he said. Investigators are working to develop methods to better identify patients who are best suited for the combination, but the presence of carcinoma in situ (CIS) does not appear to be fully predictive of response, he concluded.
During the 2025 ASCO Annual Meeting, Powles presented data from a subgroup analysis of CREST which demonstrated that patients who received sasanlimab plus BCG (n = 352) achieved an EFS benefit vs those who received BCG alone (n = 351; HR, 0.68; 95% CI, 0.49-0.94). Patients with CIS with or without Ta/T1 disease (HR, 0.53; 95% CI, 0.29-0.98), T1 disease with or without CIS (HR, 0.63; 95% CI, 0.41-0.96), and those with high-grade Ta disease with or without CIS (HR, 0.88; 95% CI, 0.46-1.70) all experienced an EFS benefit with the combination vs BCG monotherapy.
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