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Janssen Announces ERLEADA® (apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer

(J&J) Jan 30, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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.

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Tomasz M. Beer, MD, FACP (Posted: January 31, 2019)

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This study confirms one of the major trends in the field: that of intensifying upfront hormonal therapy in newly diagnosed metastatic prostate cancer. We have solid evidence that abiraterone or docetaxel improve outcomes when added to standard hormonal therapy early and now, apparently, similar results are being seen with apalutamide, an androgen receptor blocker. That is good news. We will eagerly await the full results as the magnitude of impact and the post-progression therapy experience of these patients will be an important determinant of how these results are interpreted in context.

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