BACKGROUND: We examined real-world outcomes of patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with apalutamide plus androgen deprivation therapy (ADT). The current study, reflecting real-life practice, included specific subpopulations not evaluated in the pivotal phase III TITAN study: patients diagnosed with novel imaging, patients with M1a disease only, and patients treated with concomitant radiotherapy. METHODS: ArtemisR is the first European multi-country observational study to retrospectively collect data from medical records of patients with mHSPC treated with apalutamide plus ADT in routine clinical practice. Response rates of patients with 50% and 90% decrease in PSA level (PSA50 and PSA90) compared with baseline and undetectable PSA (uPSA, < 0.2 ng/mL) were reported. Time to PSA response, time to metastatic castration-resistant prostate cancer (mCRPC), proportion of apalutamide discontinuation, and survival at 12 months were also examined using the Kaplan-Meier method. RESULTS: The analysis included 242 patients from Germany, France, Spain, and Austria; median age was 71 years. Median follow-up was 25.5 months from treatment initiation. Within 12 months of apalutamide initiation, 96% of patients achieved PSA50, 82% achieved PSA90, and 61% achieved uPSA. The median times to PSA50, PSA90, and uPSA were 1.08 months (95% confidence interval [CI]: 0.99-1.28), 1.94 months (95% CI: 1.54-2.27), and 3.48 months (95% CI: 2.92-5.68), respectively. At 12 months after treatment initiation, 94% of patients were alive, 91% had not progressed to mCRPC, and 81% remained on apalutamide plus ADT. Patients diagnosed with novel imaging, patients with M1a disease only, and patients treated with concomitant radiotherapy also showed deep and fast PSA responses (PSA90 and uPSA) with apalutamide plus ADT. Apalutamide-related adverse events (AEs) were reported in 90 patients (37%), and six patients (2.5%) discontinued apalutamide due to AEs. No new safety signals were detected. CONCLUSIONS: The ArtemisR European multi-centre study examined the efficacy and safety of apalutamide plus ADT for patients with mHSPC, further validating the deep and fast PSA response associated with this treatment regimen. These real-world outcomes were additionally observed in a more diverse patient population than that included in the pivotal TITAN study.

Clinique Pasteur Groupe ORION Toulouse France

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria

Department of Urology University Hospital Marburg Marburg Germany

Department of Urology University Hospital Münster Münster Germany

Hospital General Universitario Reina Sofía de Murcia Murcia Spain

Janssen Pharmaceutica LLC a Johnson and Johnson Company EMEA Medical Affairs Dubai United Arab Emirates

Janssen Pharmaceutica LLC a Johnson and Johnson Company EMEA Medical Affairs Porto Salvo Portugal

Janssen Pharmaceutica LLC Johnson and Johnson Company EMEA Market Access Statistics Analytics and Modelling Beerse Belgium

Medical Oncology Clinique Sainte Anne Strasbourg France

Oncology Department Institut Mutualiste Montsouris Paris France

Parexel International S R O On Behalf of Janssen Pharmaceutica LLC a Johnson and Johnson Company Medical Affairs Prague Czech Republic

Practice of Urology Study Center Urologicum Duisburg Duisburg Germany

Radio Oncology University Hospital Virgen of Arrixaca Murcia Spain

Urological Center Mittelhessen Biedenkopf Germany

Urology Hospital General Universitario Morales Meseguer Murcia Spain

Urology Urology Hospital BarmHERZige Brüder Regensburg Regensburg Germany

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