Janssen has announced that the European Commission has granted marketing authorisation for the expanded use of apalutamide to include the treatment of adult men with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy.
“Prostate cancer is the most prevalent form of cancer in men throughout Europe, and the expanded approval of apalutamide marks a significant advancement for those living with mHSPC,” said Prof Dr med Axel S Merseburger, Chairman of the Department of Urology, Campus Lübeck, University Hospital Schleswig-Holstein, Kiel, Germany. “In prostate cancer treatment, our primary goal is always to delay progression of disease and prolong survival, to ensure the best possible outcomes for patients. Today’s news is therefore an encouraging development for patients within Europe, for whom the importance of an additional treatment option that can both delay progression and extend survival cannot be underestimated.”
The EC approval is based on data from the Phase III TITAN study, which 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. The dual primary endpoints of the study were overall survival (OS) and radiographic progression-free survival (rPFS).1 Apalutamide plus ADT significantly improved OS compared to placebo plus ADT with a 33% reduction in the risk of death (HR=0.67; 95% CI, 0.51-0.89; p=0.0053).1 In both study arms, median OS was not reached.1 Apalutamide plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52% reduction in risk of radiographic progression or death compared to placebo plus ADT (HR=0.48; 95% CI, 0.39-0.60; p<0.0001).1 The median rPFS was 22.1 months for placebo plus ADT and not reached for apalutamide plus ADT.1 The two-year OS rates, after a median follow up of 22.7 months, were 82% for apalutamide plus ADT compared to 74% for placebo plus ADT.2 These results were published in The New England Journal of Medicine.1,2
1 Chi KN et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med 2019;381:13-24.
2 Chi KN. First results from TITAN: A phase III double-blind, randomized study of apalutamide versus placebo in patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy. American Society of Clinical Oncology Annual Meeting 2019. Abstract #5006.