Phase III LATITUDE clinical trial shows Zytiga (abiraterone acetate) plus prednisone shows impressive improvement in survival in metastatic prostate cancer- Janssen R&D

Janssen Research & Development announced data from the pivotal phase III LATITUDE clinical trial, which showed Zytiga (abiraterone acetate) plus prednisone, in combination with androgen deprivation therapy (ADT), demonstrated a significant improvement in overall survival (OS) and significantly prolonged radiographic progression-free survival (rPFS) in patients with high-risk metastatic hormone-naïve prostate cancer (mHNPC) compared to placebo plus ADT. Study findings indicated abiraterone acetate plus prednisone, in combination with ADT, reduced the risk of death by 38 percent compared to placebo plus ADT. Median OS for the abiraterone acetate plus prednisone in combination with ADT arm was not reached, while the median OS for the placebo plus ADT arm was 34.7 months. Additional study results found abiraterone acetate plus prednisone, in combination with ADT, decreased the risk of progression or death rPFS by 53 percent compared to placebo plus ADT in patients with mHNPC. Median rPFS was 33.0 months in the abiraterone acetate plus prednisone with ADT group, compared to 14.8 months with placebo plus ADT.

In addition to meeting the primary endpoints of OS and rPFS, the abiraterone acetate plus prednisone with ADT arm also met all secondary endpoints, with statistically significant improvements in times to pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, prostate-specific antigen (PSA) progression, and symptomatic skeletal events. Overall, the safety profile of ADT in combination with abiraterone acetate plus prednisone was consistent with prior studies in patients with metastatic castration-resistant prostate cancer (mCRPC). Grade 3/4 events reported in at least 5 percent of patients were hypertension (20%/0% vs. 10%/0.2%), hypokalemia (10%/0.8% vs. 1%/0.2%) and alanine aminotransferase increased (5%/0.3% vs. 1%/0%) in the abiraterone acetate plus prednisone with ADT vs. placebo with ADT groups, respectively. This study was presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.