Key clinical point: Apalutamide plus androgen deprivation therapy (ADT) led to 22% reduction in the risk for death in patients with nonmetastatic castration-resistant prostate cancer (CRPC) vs. placebo plus ADT.

Major finding: Apalutamide significantly improved overall survival (OS) vs. placebo (median, 73.9 vs. 59.9 months; hazard ratio [HR], 0.78; P = .016). Apalutamide reduced the risk of initiating cytotoxic chemotherapy by 37% vs. placebo (HR, 0.63; P =.0002).

Study details: In this final OS analysis of phase 3 SPARTAN study, 1,207 patients with nonmetastatic CRPC were randomly assigned (2:1) to receive ADT with either apalutamide or placebo. After unblinding, 76 patients in the placebo group without disease progression crossed over to receive open-label apalutamide.

Disclosures: The SPARTAN study was funded by Janssen Research & Development. The lead author has had advisory roles for Amgen, Bayer, Janssen Oncology, Lilly, Novartis, and Pfizer; has received compensation for travel from Amgen, Bayer, Janssen, and Lilly; and has received research funding from Bayer, Gilead Sciences, and Janssen Oncology.

Commentary

“Over the last several years, multiple androgen receptor blockers have been evaluated in the nonmetastatic castrate-resistant setting. Apalutamide was one of these agents approved for patients with PSA doubling times of 10 months or less. Smith et al. report a final overall survival analysis, where patients treated in this setting with apalutamide had a median survival of 73.9 months versus 59.9 months in those initially treated with placebo. Of note, after earlier analysis, patients randomized to the placebo arm were offered apalutamide, and 19% of patients in the placebo arm did crossover. Apalutamide is one of 3 approved agents in this setting that has led to benefits for prostate cancer patients.”

Mark Klein, MD