EU approves expanded indication for Erleada in metastatic hormone-sensitive prostate cancer.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted marketing authorisation for the expanded use of Erleada (apalutamide) to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). 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). 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=0.0053). In both study arms, median OS was not reached. 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. The median rPFS was 22.1 months for placebo plus ADT and not reached for apalutamide plus ADT. The two-year OS rates, after a median follow up of 22.7 months, were 82 percent for apalutamide plus ADT compared to 74 percent for placebo plus ADT. These results were published in The New England Journal of Medicine. The safety profile observed in the TITAN study for apalutamide plus ADT was consistent with that described in previous studies. In the study, 42 percent of patients on apalutamide plus ADT experienced Grade 3/4 adverse events (AEs), compared to 41 percent of patients on placebo plus ADT. The most common Grade of at least 3 AEs for apalutamide plus ADT versus placebo plus ADT were hypertension (8.4 percent vs. 9.1 percent) and skin rash (6.3 percent vs. 0.6 percent). Treatment discontinuation due to AEs was 8 percent in the apalutamide arm compared to 5 percent in the placebo arm.