Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that Erleada®▼(apalutamide) has been granted reimbursement in Ireland for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Professor Paul Donnellan, Consultant Medical Oncologist, Galway University Hospital, Mayo University Hospital and Galway Clinic said: “For patients with newly-diagnosed metastatic prostate cancer, delaying disease-progression and improving survival are paramount. For many years, suppressing androgen production has been the mainstay of treatment. It has been proven that adding an oral agent to this treatment, significantly improves both time to progression and overall survival, without any negative impact on Quality of Life (QoL). This represents a significant advance for all patients with advanced prostate cancer.”
Dr Thorsten Giesecke, General Manager, Commercial Business, Janssen Sciences Ireland UC, said:“Janssen is committed to improving prognosis and outcomes for men across the prostate cancer continuum with a growing portfolio and pipeline of therapeutics spanning all modalities and stages of the disease. Today’s reimbursement of apalutamide for the treatment of mHSPC represents an important, positive step on that journey.”
Data from the Phase III TITAN study assessed the addition of apalutamide to ADT in a broad range of patients with mHSPC, regardless of disease volume, prior treatment with docetaxel or staging at initial diagnosis.1 The dual primary endpoints of the study were overall survival (OS) and radiographic progression-free survival (rPFS).1,2 Data from the interim analysis2 showed that at 24 months, apalutamide plus ADT significantly improved OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95% CI, 0.51-0.89; p=0.005).2 The interim analysis also revealed that apalutamide plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent reduction in risk of radiographic progression or death compared to placebo plus ADT (HR=0.48; 95% CI, 0.39-0.60; p<0.001).2
The final analysis of TITAN and its long-term results demonstrate that apalutamide plus ADT consistently provides significant improvements in OS and delays onset of progression.1 The OS rates at 48 months were 65.1% and 51.8% for apalutamide- and placebo-treated patients, respectively.1
The safety profile observed in the TITAN study for apalutamide plus ADT was consistent with that described in previous studies.2,3 In the final analysis, the overall incidence of any treatment-emergent adverse events (TEAEs) was similar between treatment groups and to those reported previously.1 The most common treatment-related AEs (adverse events) related to treatment with apalutamide were rash and fatigue.1 There were no treatment-related deaths.1