2019 American Society of Clinical Oncology (ASCO) Annual Meeting - Darolutamide data presented - Seite 2

"At this stage of prostate cancer, when men typically feel well and generally do not have symptoms, it is important that we have potential treatment options that will prevent the spread of prostate cancer for as long as possible, while limiting burdensome side effects of therapy, which allows patients to continue their day-to-day lives," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, University of Paris Sud, France. "These new data demonstrate darolutamide's ability to maintain patients' quality of life while receiving treatment. When you add these findings to previously reported data, the product has the potential to become an important treatment option for men with nmCRPC."

"The results from the ARAMIS trial published recently in the New England Journal of Medicine showed that Darolutamide is highly effective in the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and that darolutamide has an excellent safety profile that resembles that of placebo. The new analyses from the ARAMIS trial show that patients treated with Darolutamide maintain their quality of life while on Darolutamide treatment, which is very good news for the patients. These highly important results encourage us further to bring this treatment to nmCRPC patients as soon as possible," said Christer Nordstedt, MD, PhD, Senior Vice President, Research and Development, Orion Corporation.

Darolutamide data presented at ASCO
In an analysis focusing on patient-relevant endpoints, data on the secondary endpoint of time to pain progression, assessed by the BPI-SF (Brief Pain Inventory - Short Form) patient questionnaire, show that darolutamide plus ADT delayed worsening of pain in men with nmCRPC versus placebo plus ADT (40.3 versus 25.4 months; HR 0.65; 95% CI 0.53-0.79; P<0.001).¹ At this interim analysis, the results are not statistical significant.¹

In a pre-planned analysis on the FACT-P PCS (Functional Assessment of Cancer Therapy - Prostate, Prostate Cancer Subscale) questionnaire, quality of life was maintained in men receiving treatment with darolutamide plus ADT, as demonstrated by mean scores from the FACT-P PCS.¹ FACT-P PCS assesses both impact of disease- and treatment related symptoms on men's quality of life, and was assessed every 16 weeks until end of study treatment, and at every visit thereafter until end of study or death.¹ Mean scores were maintained and similar in both treatment arms throughout the study. At the end of treatment, the mean change from baseline of -8.55 with darolutamide plus ADT was similar to placebo plus ADT.¹ The quality of life scores were maintained beyond end of study treatment.