Janssen announced the U.S. Food and Drug Administration (FDA) has approved a new indication for ZYTIGA (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, ZYTIGA in combination with prednisone reduced the risk of death by 38 percent compared to placebos.
"LATITUDE was a large global trial which produced impressive and clinically significant results in overall survival," said Karim Fizazi, M.D., Ph.D., Principal Investigator and Head of the Medical Oncology Department at Institute Gustave Roussy, Villejuif, France. "With today's approval, abiraterone acetate plus prednisone could become a standard of care for patients with metastatic high-risk castration-sensitive prostate cancer."
LATITUDE was a multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial that examined the use of ZYTIGA 1,000 mg once daily in combination with prednisone 5 mg once daily, compared to placebos (N=1,199) in patients with newly diagnosed, metastatic high-risk CSPC, who had not received prior cytotoxic chemotherapy. All the patients received a gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. The study data were presented at the plenary session of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, and simultaneously published in The New England Journal of Medicine. The study showed ZYTIGA in combination with prednisone reduced the risk of death by 38 percent compared to placebos (median OS not estimable vs. 34.7 months, respectively; hazard ratio (HR)=0.62; 95% confidence interval (CI): [0.51, 0.76], p<0.0001). Additional data demonstrated statistically significant delay in time to initiation of chemotherapy for patients in the ZYTIGA arm compared to those in the placebo arm (median time to initiation of chemotherapy not reached vs. 38.9 months, respectively; HR=0.44; 95% CI: [0.35, 0.56], p < 0.0001).
The most common adverse reactions (≥10%) that occurred more commonly (>2%) in the ZYTIGA arm from an analysis of pooled safety data were fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough and headache.
On November 20, 2017, the European Commission (EC) granted approval to broaden the marketing authorization for ZYTIGA in combination with prednisone or prednisolone to include newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (HSPC). Similar submissions have been made in Japan, Canada, Mexico, Switzerland, Singapore, and the Philippines, and approved in Brazil and Taiwan. If approved, these submissions will broaden the use of ZYTIGA in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.
Metastatic prostate cancer is cancer that has spread to another part of the body. Metastatic castration-sensitive prostate cancer (CSPC), also referred to as metastatic hormone-sensitive prostate cancer (HSPC) in literature, refers to prostate cancer that still responds to testosterone suppression therapy. Patients with newly-diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.