Janssen’s Erleada meets primary endpoints in ongoing trial into metastatic castration-sensitive prostate cancer

pharmafile | January 31, 2019 | News story | Research and Development Cancer, Erleada, Janssen, pharma, prostate cancer 

Janssen has revealed that its androgen receptor (AR) inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), has been performing well in ongoing clinical studies investigating its efficacy in the treatment of metastatic castration-sensitive prostate cancer (mCSPC).

Things are going well enough, in fact, that the company announced it is to unblind the Phase 3 study, allowing patinets in the placebo plus ADT group to cross over to receive treatment in the Erleada plus ADT group. The decision was made on the recommendation of an Independent Data Monitoring Committee (IDMC), and this recommendation coincided with a pre-planned analysis which revealed that the therapy met both of its primary endpoints, “significantly improving” radiographic progression-free survival (rPFS) and overall survival (OS).

“The TITAN study was designed to evaluate the efficacy and safety of ERLEADA in combination with androgen deprivation therapy in patients with newly-diagnosed metastatic castration-sensitive prostate cancer, regardless of the extent of their disease,” remarked Dr Margaret Yu, Vice President, Oncology Clinical Development at Janssen. “We look to continue to build upon our understanding of ERLEADA for patients with metastatic prostate cancer as there remains a significant unmet need for additional treatment options.”

Janssen confirmed that full results of the study will be presented at an upcoming medical meeting, with regulatory approval to be sought sometime in 2019.

Matt Fellows

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