Johnson & Johnson unveiled new late-stage data on Saturday at the annual American Society for Clinical Oncology meeting for abiraterone acetate (Zytiga) that could bolster its chances of gaining a label expansion.
Investigators presented findings from a phase III clinical trial where they tested Zytiga in conjunction with standard hormone therapy against placebo on 1,199 male patients newly diagnosed with high-risk metastatic hormone-naïve prostate cancer.
An approximate 597 patients were randomized to receive Zytiga and prednisone along with androgen deprivation therapy (ADT) while 602 patients received ADT and placebo.
Results from the trial revealed the triple Zytiga combination hit the primary endpoint by demonstrating a significant improvement in overall survival rates (OS) and significantly prolonged radiographic progression-free survival (rFPS).
Overall, this form of treatment lowered the risk of death by 38 percent compared to placebo while also reducing the risk of progression or death rFPS by 53 percent versus placebo.
A number of secondary endpoints like statistically significant improvements in times to pain progression and next subsequent therapy for prostate cancer were reached as well.
“Improvements in the care and treatment of prostate cancer at all stages of its progression are vital. That is especially true for those men who face high-risk metastatic hormone-naïve prostate cancer, a traditionally difficult type of cancer to treat,” said Marco Gottardis, Ph.D., the Vice President and Prostate Cancer Disease Area Stronghold Leader at Janssen, Johnson & Johnson’s biotech unit, in a statement. We are encouraged by these positive results for abiraterone acetate in hormone-naïve advanced prostate cancer and are committed to continue developing medicines that can benefit patients at all stages of this serious disease.”
Zytiga was engineered as a pill to decrease testosterone production, which is the hormone that stimulates prostate tumor growth, according to Reuters.
It gained its first regulatory in 2011 as a combination treatment with prednisone/prednisolone in 105 countries.
The company has submitted filing to the European Medicines Agency along with other countries in hopes of expanding the marketing authorization to include the treatment of men with this form of cancer.
Gaining approval for these expansions would give Zytiga broadened use in an earlier stage of prostate cancer.
Filed Under: Drug Discovery
