Dr Tyson on the Appropriate Use of Durvalumab Plus BCG in BCG-Naive High-Risk NMIBC

“The clinical implications of [these data] are nuanced. The risk of durvalumab is clearly not worth it for patients who have small volume, high-grade Ta disease [or for those] who have a little bit of CIS that you clean up with blue light.”

Mark D. Tyson, II, MD, MPH, a urologic oncologist at Mayo Clinic, discussed the clinical implications of the primary results from the phase IIIb PATAPSCO trial (NCT05943106)of durvalumab (Imfinzi)in combination with BCG in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC) that were presented during 2026 American Urological Association (AUA) Annual Meeting.

Tyson emphasized that the use of durvalumab in this setting requires nuanced patient selection, cautioning that the risk profile of the combination is unlikely to be justified across the broad NMIBC population. Specifically, he noted that patients with small-volume, high-grade Ta disease; limited carcinoma in situ (CIS) addressed with blue light cystoscopy; or small-volume T1 disease free of residual tumor on repeat resection represent lower-risk scenarios in which the addition of durvalumab would not be warranted.

Tyson outlined a higher-risk patient profile for whom this combination therapy could be most meaningfully considered. This includes patients with high-volume T1 disease, concomitant CIS, possible variant histology, and persistent T1 or CIS on repeat resection. For these patients, radical cystectomy would represent the standard recommended approach, he explained. In cases where patients, particularly younger individuals with preserved physiologic reserve, decline cystectomy despite emphatic recommendation, Tyson asserted that the durvalumab-based combination may represent a clinically justifiable alternative given the non-negligible risk of progression to metastatic disease in this population.

Tyson noted that FDA approval would further support the use of this regimen in select patients for whom the risks of immunotherapy are offset by the severity of the underlying disease and the consequences of forgoing definitive surgical management.

Ultimately, Tyson concluded that durvalumab-based combination therapy should not be broadly applied to all high-grade Ta or CIS patients, but rather be reserved for those at the highest risk of progression who are unwilling or unable to undergo cystectomy.