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Published on: March 6, 2018
Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer
Matthew R Smith1, Maha Hussain1, Fred Saad1
1From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Adding darolutamide to androgen-deprivation therapy and docetaxel significantly improved overall survival in patients with metastatic, hormone-sensitive prostate cancer. The combination therapy showed similar adverse event profiles compared to placebo.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Darolutamide, an androgen-receptor inhibitor, improves survival in nonmetastatic prostate cancer.
- The efficacy of combining darolutamide with androgen-deprivation therapy and docetaxel in metastatic prostate cancer was previously unknown.
Purpose of the Study:
- To evaluate the impact of adding darolutamide to androgen-deprivation therapy and docetaxel on overall survival in patients with metastatic, hormone-sensitive prostate cancer.
Main Methods:
- An international, phase 3, randomized trial assigned patients with metastatic, hormone-sensitive prostate cancer to receive either darolutamide or placebo.
- Both groups received androgen-deprivation therapy and docetaxel.
- The primary endpoint was overall survival.
Main Results:
- The darolutamide group demonstrated a significant 32.5% reduction in the risk of death (HR 0.68; P<0.001).
- Consistent benefits were observed across secondary endpoints and subgroups.
- Adverse event profiles were similar between the darolutamide and placebo groups, with neutropenia being the most common severe adverse event.
Conclusions:
- Combining darolutamide with androgen-deprivation therapy and docetaxel significantly increases overall survival in metastatic, hormone-sensitive prostate cancer.
- The addition of darolutamide also improved key secondary endpoints.
- The safety profile was comparable to placebo, with similar adverse event frequencies.
