Abiraterone Acetate Plus Prednisone Provided Significant Clinical Benefit in Patients with High-Risk Metastatic Hormone-Naïve Prostate Cancer (mHNPC), Improving Overall Survival and Radiographic Progression-Free Survival

Beerse, Belgium, 3 June, 2017 – Janssen-Cilag International NV today announced data from the pivotal Phase 3 LATITUDE clinical trial, which showed Zytiga® (abiraterone acetate) plus prednisone, in combination with androgen deprivation therapy (ADT), compared to ADT plus placebo, demonstrated a significant improvement in overall survival (OS) and radiographic progression-free survival (rPFS) in patients with newly diagnosed high-risk metastatic hormone-naïve prostate cancer (mHNPC) (patients who had not been previously treated with ADT).1 These data were selected as one of four data sets for inclusion in the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting Press Program in Chicago, today at 8 – 9 a.m. CDT. Additionally, the data results will be presented during the “Plenary Session: Including the Science of Oncology Award and Lecture,” on Sunday, 4th June, at 2:40 – 2:55 p.m. CDT (Abstract LBA3). The data have been selected for “Best of ASCO” Meetings, which highlight the most cutting-edge science and education from the ASCO Annual Meeting, and reflect the foremost oncology research and strategies that will directly impact patient care.

Study findings indicated that treatment with abiraterone acetate plus prednisone, in combination with ADT, reduced the risk of death compared to ADT and placebo (hazard ratio [HR]=0.62; 95% CI [0.51 to 0.76], p<0.0001). Additional study results found that treatment with abiraterone acetate plus prednisone, in combination with ADT, reduced the risk of disease progression on scans or death compared to ADT plus placebo in patients with mHNPC (HR=0.47; 95% CI [0.39 to 0.55], P <0.0001).1 Median rPFS was 33.0 months with ADT in combination with abiraterone acetate plus prednisone, compared to 14.8 months with ADT and placebo.1

“In the LATITUDE trial, we found that abiraterone acetate plus prednisone, in combination with androgen deprivation therapy, demonstrated statistically significant and clinically meaningful improvements in patients with high-risk metastatic hormone-naïve prostate cancer,” said Dr. Karim Fizazi, Principal Investigator of the trial and Head of the Medical Oncology Department at Institute Gustave Roussy. “This is important new information, as not all patients respond well to the current standard of care. LATITUDE suggests that abiraterone acetate plus prednisone, in combination with androgen deprivation therapy, can offer a new and much-needed option for patients with high-risk newly diagnosed mHNPC.”

Expert spokespeople available for interview

  • Dr. Karim Fizazi, Principal Investigator of the trial and Head of the Medical Oncology Department at Institute Gustave Roussy
  • Dr. Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen Europe, Middle East, Africa

Reference

  1. Fizazi, K. LATITUDE: A phase III, double-blind, randomized trial of androgen deprivation therapy with abiraterone acetate plus prednisone or placebos in newly diagnosed high-risk metastatic hormone-naive prostate cancer. Abstract LBA3. Presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, 4th June 2017. Available at: http://abstracts.asco.org/199/AbstView_199_181729.html. Accessed May 2017.

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