Oncology Pulsepoint: Can Durvalumab Plus BCG Change Practice in High-Risk NMIBC?

In an interview with Pharmacy Times, Ming-Hei Tai, PharmD, BCOP, oncology pharmacist at William Beaumont University Hospital, discussed how recent developments in non–muscle-invasive bladder cancer (NMIBC) may affect clinical practice, emphasizing that bacillus Calmette-Guérin (BCG) remains a highly effective treatment when administered at the appropriate dose and schedule.

Tai explained that many newer bladder-preserving therapies were evaluated in single-arm trials involving patients with BCG-unresponsive carcinoma in situ. Because these studies lacked direct comparators, clinicians should be cautious when attempting to determine whether one treatment is more effective than another. He noted that ongoing BCG shortages may further complicate treatment decisions, as some patients classified as BCG unresponsive may not have received an adequate course of full-dose BCG. In certain cases, retreatment with properly dosed BCG may therefore remain reasonable before transitioning to a newer therapy.

Tai also evaluated the role of durvalumab plus BCG in BCG-naïve, high-risk NMIBC. Although the regimen improved disease-free survival compared with BCG alone, he questioned whether the magnitude of benefit justifies exposing patients with localized disease to systemic immunotherapy. According to Tai, the combination primarily reduced local bladder recurrences without demonstrating a clear reduction in systemic relapse or an overall survival benefit.

He highlighted that approximately three-quarters of patients receiving BCG alone remained disease free at 3 years, resulting in an absolute improvement of approximately 7% with the addition of durvalumab. This translates to treating roughly 14 patients for 1 patient to benefit, while approximately 1 in 4 patients receiving durvalumab experienced a grade 3 or higher adverse event.

Tai concluded that durvalumab plus BCG remains a potential option for selected patients who prioritize reducing their risk of recurrence. However, shared decision-making is essential when balancing its modest disease-free survival benefit against the risk of systemic and potentially persistent immune-related toxicities.