Data from Pharmawand - Curated by EPG Health - Date added 02 February 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the unblinding of the Phase III 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.
"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. 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 III TITAN study are planned for 2019.