Durvalumab shows no OS detriment in high-risk NMIBC
By Sudha Thakor
The addition of durvalumab to bacillus Calmette–Guérin (BCG) induction and maintenance therapy shows no detriment to overall survival (OS) and does not meaningfully impact quality of life (QoL) in patients with high-risk non–muscle-invasive bladder cancer (NMIBC), according to the phase 3 POTOMAC study (NCT03528694) presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
At the planned 5-year analysis, OS rates were 88% with durvalumab plus BCG versus 86% with BCG alone, with no evidence of reduced survival following the addition of durvalumab.
Earlier results from POTOMAC demonstrated a statistically significant improvement in disease-free survival (DFS) with the addition of durvalumab (hazard ratio, 0.68), alongside delays in high-risk disease recurrence and fewer cystectomies.
Maria De Santis (Charité – Universitätsmedizin Berlin, Germany), presenting the data, further reported that the addition of durvalumab to BCG induction and maintenance “did not have a major impact on patient-reported quality of life,” with similar outcomes observed across treatment arms. De Santis added that “data further support 1 year of durvalumab in combination with BCG induction and maintenance as a new treatment for patients with BCG-naive, high-risk NMIBC.”
Patient-reported outcomes, assessed using validated questionnaires (EORTC QLQ-C30, EORTC QLQ-NMIBC24, and PRO-CTCAE), showed modest deterioration from baseline over time in both arms, including worsening fatigue and urinary symptoms. However, differences between treatment groups were not clinically meaningful, with similar proportions of patients reporting worsening symptoms, including urinary frequency, diarrhea, and painful urination.
The study randomized 1,018 patients with BCG-naive, high-risk NMIBC to receive durvalumab plus BCG induction and maintenance, durvalumab plus BCG induction alone, or BCG induction and maintenance alone.
At a median follow-up of approximately 72 months, the addition of durvalumab was associated with a manageable safety profile consistent with the known effects of the individual therapies, with no new safety signals reported.
De Santis concluded that “these findings support the use of durvalumab in combination with BCG in BCG-naive, high-risk NMIBC, with no compromise in survival outcomes or patient-reported quality of life.”
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