Newswire (Published: Thursday, February 7, 2019, 11:02:00 AM CST, Received: Thursday, February 7, 2019, 12:01:49 PM CST)

Word Count: 314

By a News Reporter-Staff News Editor at Cancer Weekly -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced the unblinding of the Phase 3 TITAN study evaluating ERLEADA® (apalutamide) plus androgen deprivation therapy (ADT) in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The decision resulted from an Independent Data Monitoring Committee (IDMC) recommendation coinciding with a pre-planned analysis that showed the dual primary endpoints were both achieved, significantly improving radiographic progression-free survival (rPFS) and overall survival (OS). Based on these results, the IDMC recommended that patients in the placebo plus ADT group be given the opportunity to cross over to treatment with ERLEADA plus ADT. Patients will continue to be followed for OS and long-term safety as part of the TITAN study (see also Janssen Pharmaceutical Companies of Johnson & Johnson).

"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," said Margaret Yu, M.D., Vice President, Oncology Clinical Development, Janssen Research & Development, LLC. "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."

Results from the TITAN study will be submitted for presentation at an upcoming medical congress. Applications seeking regulatory approval of ERLEADA supported by data from the Phase 3 TITAN study are planned for 2019.

About Metastatic Castration-Sensitive Prostate Cancer

Metastatic prostate cancer is cancer that has spread to another part of the body.1 Metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT.1 Patients with newly-diagnosed metastatic disease tend to have a poorer prognosis, resulting in a need for new treatment options.2,3

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