Janssen announces data from the pivotal phase 3 LATITUDE clinical trial, which showed ZYTIGA (abiraterone acetate) plus prednisone, in combination with androgen deprivation therapy ("ADT"), demonstrated a significant improvement in overall survival and significantly prolonged radiographic progression-free survival 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% compared to placebo plus ADT (Hazard Ratio [HR]=0.62; 95 percent CI [0.51 to 0.76], P<0.0001). 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 (HR=0.47%, 95% CI [0.39 to 0.55], P <0.0001). 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 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."
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 (NYSE:PSA) progression (P<0.0001), and symptomatic skeletal events (p=0.0086).
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 ≥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.
Source: Press Release
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