Johnson & Johnson on Wednesday announced that Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), met the primary endpoints of a Phase III study of patients with metastatic castration-sensitive prostate cancer (mCSPC). The company said the Independent Data Monitoring Committee recommended that based on the findings, patients in the placebo arm be allowed to cross over to the Erleada arm.
Margaret Yu, vice president of oncology clinical development at Johnson & Johnson's Janssen R&D unit, stated "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."
In the TITAN study, more than 1050 patients with mCSPC were randomly assigned to treatment with Erleada or placebo, both in combination with ADT. The primary endpoints of the study were radiographic progression-free survival and overall survival. Secondary goals include time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event.
Johnson & Johnson indicated that data from the study will support regulatory submissions of Erleada for the treatment of mCSPC later this year. The drugmaker also plans to submit the study findings for presentation at a future research conference.
Erleada was approved last year in the US and EU for the treatment of non-metastatic castration-resistant prostate cancer. Johnson & Johnson had previously identified the androgen receptor inhibitor as one of more than 10 drugs with blockbuster potential that it would launch or seek approval for through 2021.
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