J&J’s prostate cancer drug Zytiga shows significant effect in phase 3 trial

Janssen Research & Development announced that Zytiga plus prednisone, in combination with androgen deprivation therapy (ADT) has showed a significant improvement in overall survival (OS) and prolonged radiographic progression-free survival (rPFS) in patients with high-risk metastatic hormone-naïve prostate cancer (mHNPC) compared against placebo plus ADT.

Zytiga in combination with prednisone is being used to treat metastatic castration-resistant prostate cancer (mCRPC).

It blocks CYP17-mediated androgen production, which expands prostate cancer growth at three source, including the testes, adrenals and the prostate tumor tissue.

The study results have demonstrated that abiraterone acetate plus prednisone, in combination with ADT, has decreased the risk of death by 38% compared against placebo plus ADT.

Zytiga plus prednisone with ADT arm also achieved all secondary endpoints with with statistically significant improvements, in addition to meeting the primary endpoints of OS and rPFS.

The LATITUDE is a phase 3, multinational, multicenter, randomized, double-blind and placebo-controlled trial, which recruited 1,199 newly diagnosed patients with mHNPC. It was carried out at 235 sites in 34 countries in Europe, Asia-Pacific, Latin America, and Canada.

Janssen submitted a Type II variation application to the European Medicines Agency (EMA) to expand the existing marketing authorization for abiraterone plus prednisone or prednisolone to include the treatment of men with mHNPC.

The trial principal investigator Karim Fizazi said: “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.”

Image: Johnson & Johnson headquarters in New Brunswick, New Jersey. Photo: courtesy of Nikopoley.