Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial

Maria De Santis, Joan Palou Redorta, Hiroyuki Nishiyama, Michał Krawczyński, Artur Seyitkuliev, A. M. Novikov, Félix Guerrero‐Ramos, Р. А. Зуков, Minoru Katō, Takashi Kawahara, Lieven Goeman, Javier Puente, Eva Hellmis, Thomas Powles, Piotr Radziszewski, Kilian M. Gust, P. Vasey, Pierre Bigot, Yves Fradet, Jarmo C. B. Hunting, J. Armstrong, Suliman Boulos, Stephan Hois, Neal D. Shore, Paul Anderson, Daniel Brungs, Ian D. Davis, Amanda Glasgow, Carole A. Harris, Phillip Parente, Manish Patel, P. Vasey, Ian Vela, Robert Zielinski, Johannes W. Buchegger, Kilian M. Gust, W. Horninger, Georg C. Hutterer, Wolfgang Loidl, Ferdinand Luger, Lukas Lusuardi, Renate Pichler, Filip Ameye, Lieven Goeman, Steven Joniau, Thierry Roumeguère, Yves Fradet, Jason Izard, Girish S. Kulkarni, Jean-Benoit Paradis, Fred Saad, Abdel Rahmene Azzouzi, Philippe Barthélémy, Pierre Bigot, Marc Colombel, J. Deturmeny, Thierry Lebrét, G. Robert, Fabien Saint, Delphine Topart, Martin Bögemann, Jozefina Casuscelli, Maria De Santis, Susan Feyerabend, M. Garcia-Schürmann, Gencay Hatiboglu, Axel Hegele, Eva Hellmis, Christian Keil, Jörg Klier, Thomas Pulte, Lars Pursche, Bernd J. Schmitz‐Dräger, Viktoria Schütz, Philipp Spiegelhalder, E. Stagge, Georgi Tosev, Christoph von Klot, Gaku Arai, Kensuke Bekku, Toshiki Etani, Katsuyoshi Hashine, Junichi Inokuchi, Koji Izumi, Kouji Izumi, Toshiyuki Kamoto, Shuya Kandori, Minoru Kato, Takashi Kawahara, Noriyasu Kawai, Eiji Kikuchi, Tomokazu Kimura, Hiroshi Kitamura, Yasuyuki Kobayashi, Yukihiro Kondo, Naoya Masumori, Tomohiro Matsuo, Yasuyoshi Miyata, Ryuichi Mizuno, Shoichiro Mukai

The Lancet · 2025

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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.

Theme
General food systems / other
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s0140-6736(25)01897-5
Catalogue ID
SNmoh0dtgr-1j8u11

Topic tags

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