This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy (ADT).1 Men with non-metastatic CRPC with a rapidly rising PSA are at high risk for developing metastatic disease.2,3 The primary endpoint of this study was metastasis free survival (MFS).1 MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.4 The SPARTAN study results will be presented at a future medical meeting.
"The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course. We have demonstrated that treating patients before the disease has metastasized improves outcomes," said
Prostate cancer is the most common cancer among American men, other than skin cancer.5 According to the
Non-metastatic castration-resistant prostate cancer refers to patients with CRPC who lack detectable distant metastatic disease.7,8 These individuals have a rising PSA, testosterone level below 50 ng/dl and bone scan and CT scans that show no evidence of spread to bones or visceral organs.9 Men with rapidly rising PSA have a high unmet medical need, as these patients are at high risk for developing metastatic disease.10
About Apalutamide (ARN-509)
Apalutamide is an investigational, next generation oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development of apalutamide. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
1 Clinical trials gov. A Study of Apalutamide (ARN-509) in Men with Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN). Available at: https://clinicaltrials.gov/ct2/show/NCT01946204. Accessed
2 Smith MR, et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol. 2005;23:2918-2925.
3 Lin JH, et al. Association of prostate specific-antigen doubling time (PSADT) with metastasis-free survival (MFS) and overall survival (OS) in non-metastatic castration-resistent prostate cancer (nmCRPC). J Clin Oncol 2017;35(15 suppl). Abstract e16525.
4 Xie W, et al. Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.
6 Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011;65:1180-1192.
7 Scher HI, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the
8 Scher HI, et al. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the
9 Virgo K, et al. Second-Line Hormonal Therapy for Men With Chemotherapy-Naïve, Castration-Resistant Prostate Cancer:
10 Modern Medicine. "Treatment of Nonmetastatic Castration-Resistant Prostate Cancer." Available at: http://www.cancernetwork.com/oncology-journal/treatment-nonmetastatic-castration-resistant-prostate-cancer. Accessed
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