In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.
Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.
All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1.
Long-term darolutamide treatment was well tolerated; no new safety signals observed. In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.
Prostate cancer and prostatic diseases. 2023 Oct 26 [Epub ahead of print]
Robert Hugh Jones, Karim Fizazi, Nicholas D James, Teuvo L Tammela, Nobuaki Matsubara, Frank Priou, Philippe Beuzeboc, Thierry Lesimple, Petri Bono, Vesa Kataja, Jorge A Garcia, Andrew Protheroe, Neal Shore, John Aspegren, Heikki Joensuu, Iris Kuss, Sabine Fiala-Buskies, Egils Vjaters
Cardiff University and Velindre Cancer Centre, Cardiff, UK. ., Institut Gustave Roussy, University of Paris Saclay, Villejuif, France., The Institute of Cancer Research, London, UK., Tampere University Hospital, Tampere, Finland., National Cancer Center Hospital East, Chiba, Japan., Centre Hospitalier Départemental Vendée, La Roche-Sur-Yon, France., Curie Institute, Paris, France., Centre Eugène Marquis, Rennes, France., Terveystalo Finland and University of Helsinki, Helsinki, Finland., Kuopio University Hospital, Kuopio, Finland., University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, OH, USA., Oxford University Hospitals NHS Foundation Trust, Oxford, UK., Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA., Orion Corporation, Espoo, Finland., Bayer AG, Berlin, Germany., Bayer AG, Wuppertal, Germany., P. Stradins Clinical University Hospital, Riga, Latvia.