(Vienna, 1 March 2018) A new drug for treating prostate cancer has the ability to extend survival by more than two years. These are the findings – recently published in the prestigious New England Journal of Medicine – of the international SPARTAN study, in which MedUni Vienna played contributed. Apalutamide is a new therapeutic agent for treating advanced prostate cancer by delaying metastasis. It is the first, and so far the only drug treatment approved by the Food and Drug Administration in the USA for treating men with non-metastatic prostate cancer, who no longer respond to standard hormone withdrawal (chemical or surgical castration).
Apalutamide is a next-generation, non-steroidal inhibitor that delays the growth of the prostate tumour induced by the male sex hormone testosterone. "Apalutamide is used when prostate cancer cells have not yet been discovered in other parts of the body but hormone treatments or surgeries are not sufficient to prevent further tumour growth. We term this the non-metastatic castration-resistant stage of prostate cancer," explains Michael Krainer from the Department of Medicine I at MedUni Vienna/Vienna General Hospital. MedUni Vienna's internationally recognised Urological Tumours Working Group, led by Krainer, was invited to take part in this high-level, international, Phase-3 clinical study.
A total of 1,207 men participated in the SPARTAN study, which was conducted in North America, Australia, Russia, Asia and European countries. In a ratio of 2:1, patients were either given Apalutamide in combination with androgen deprivation therapy (ADT) or placebo in combination with ADT. The study shows that, compared with the placebo group, the tumour growth and death risk in the Apalutamide group was reduced by 72%, and metastasis delayed by 24.3 months.
Apalutamide was recently approved by the US Food and Drug Administration (FDA) using a fast-track procedure. This makes apalutamide the first and so far the only approved therapeutic agent for treating non-metastatic castration-resistant prostate cancer. An approval application was simultaneously submitted to the European Medicines Agency (EMA).
Since 2002, Michael Krainer and his team at MedUni Vienna have been supporting the development of a wide range of prostate cancer treatments, from chemotherapy and hormone therapy through to immunotherapy. Speaking about the approval of Apalutamide, Krainer says, "We have set a new milestone and I am delighted that our contribution to the clinical research has resulted in the approval of a new treatment option." In subsequent projects, the Working Group will also classify prostate cancer using modern molecular genetic methods, so as to offer patients further treatments.
About prostate cancer
Prostate cancer is the second commonest male cancer worldwide. 365,000 men were diagnosed with prostate cancer in the EU in 2015. Patients with hormone-resistant prostate cancer require other options for treatment. According to research findings in the USA, in five years from now, 10 – 20% of all prostate cancers will become castration resistant.
Service: New England Journal of Medicine
Originalpublikation: Smith MR, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Feb 8. doi: 10.1056/NEJMoa1715546 [Epub ahead of print] http://www.nejm.org/doi/full/10.1056/NEJMoa1715546