Janssen Pharmaceutical Companies of Johnson & Johnson has unblinded the Phase III TITAN trial investigating Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
The development follows recommendation provided by an Independent Data Monitoring Committee (IDMC) and a pre-planned evaluation that showed that the trial achieved its dual primary endpoints of improving radiographic progression-free survival (rPFS) and overall survival (OS).
IDMC suggested that patients in the placebo plus ADT group should be allowed to cross over to treatment with Erleada plus ADT. However, the TITAN trial will continue to follow patients for OS and long-term safety results.
Janssen Research & Development Oncology Clinical Development vice-president Margaret Yu said: “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.
“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.”
Janssen plans to submit applications seeking regulatory approval of Erleada based on results from the TITAN trial within this year.
TITAN features a randomised, placebo-controlled, double-blind design. It includes more than 1,050 men who were newly diagnosed with metastatic disease, irrespective of prognostic risk, volume of disease, prior treatment with docetaxel or treatment of localised disease.
Patients with mCSPC were randomised to be treated with either Erleada plus ADT or placebo plus ADT as part of the trial.
The trial’s secondary endpoints comprise time to chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal-related event.