Summary
This phase 3 randomised controlled trial, as suggested by the POTOMAC trial design and publication in The Lancet, evaluated the efficacy and safety of durvalumab (an anti-PD-L1 checkpoint inhibitor) combined with intravesical BCG immunotherapy in BCG-naive patients with high-risk, non-muscle-invasive bladder cancer. The final analysis of this multicentre international trial provides evidence on whether combining checkpoint inhibition with standard BCG therapy improves oncological outcomes and tolerability compared with BCG alone. Results are intended to inform treatment guidelines for this patient population.
UK applicability
The trial enrolled participants across multiple countries including the United Kingdom, and findings would directly inform National Institute for Health and Care Excellence (NICE) guidance and NHS clinical practice for bladder cancer management. UK patients and clinicians may benefit from evidence on whether combination immunotherapy improves outcomes over standard BCG monotherapy.
Key measures
Recurrence-free survival, disease progression, adverse events, patient safety and tolerability in bladder cancer patients receiving combination immunotherapy
Outcomes reported
The study evaluated efficacy and safety of durvalumab in combination with Bacillus Calmette-Guérin (BCG) immunotherapy in patients with BCG-naive, high-risk, non-muscle-invasive bladder cancer. Primary endpoints likely included recurrence-free survival, disease-free survival, or related oncological outcomes.
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