The Janssen Pharmaceutical Companies of Johnson & Johnson announced unblinding of the phase III TITAN study evaluating Erleada (apalutamide) plus androgen deprivation therapy in the treatment of patients with metastatic castration-sensitive prostate cancer.
The decision resulted from an Independent Data Monitoring Committee recommendation coinciding with a pre-planned analysis that showed the dual primary endpoints were both achieved, significantly improving radiographic progression-free survival and overall survival.
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, vice president, Oncology Clinical Development, Janssen Research & 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, the company said.
TITAN is a phase III randomized, placebo-controlled, double-blind study in men who were newly diagnosed with metastatic disease, regardless of prognostic risk, volume of disease, prior treatment with docetaxel or treatment of localized disease.
More than 1,050 patients with mCSPC were randomized to receive either Erleada plus ADT, or placebo plus ADT. Participants were treated until disease progression or the occurrence of unacceptable treatment related toxicity, or end of treatment.
The dual primary endpoints of the study are rPFS and OS.4 Secondary endpoints of the study include time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event. For additional study information, visit ClinicalTrials.gov.
Erleada (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer. It became the first treatment to receive FDA approval for this disease state on Feb. 14, 2018.
The NCCN Clinical Practice Guidelines in Oncology for Prostate Cancer include apalutamide as a treatment option for patients with non-metastatic CRPC with a category 1 recommendation (especially for those with a PSA doubling time ≤10 months)*.
Additionally, the American Urological Association Guidelines for Castration-Resistant Prostate Cancer were updated to include apalutamide with continued ADT as a treatment option that clinicians should offer to patients with asymptomatic nmCRPC. It is included as one of the options clinicians should offer to patients with nmCRPC who are at high-risk for developing metastatic disease (Standard; Evidence Level Grade A).
