Apalutamide Demonstrates Strong PSA Response in Patients With Advanced Prostate Cancer

Apalutamide (Erleada, Johnson & Johnson) demonstrated a strong prostate-specific antigen (PSA) response and high adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in a clinical setting, according to data presented at the virtual American Urological Association Annual Meeting (AUA 2021).

This PSA response was also observed in a separate post-hoc analysis, which demonstrated a correlation between rapid and deep PSA response and prolonged survival for patients with either metastatic castration-sensitive prostate cancer (mCSPC) or nmCRPC.

The analysis of the phase 3 TITAN and SPARTAN studies evaluated PSA kinetics in 2259 patients with either mCSPC or nmCRPC. According to the results, patients with advanced prostate cancer treated with apalutamide in combination with androgen deprivation therapy (ADT) had significant, rapid, and durable declines in PSA in as few as 3 months following the initiation of therapy. These declines were also observed to continue beyond 1 year after the start of treatment.

“The sooner that urologists and oncologists have an indicator that a patient is benefitting from a therapy, the better able they are to provide the best care,” said Tracy McGowan, MD, therapeutic head of Prostate Cancer, US Medical Affairs at Janssen Biotech, in a press release. “As reported in this post-hoc analysis, PSA is an important early predictive indicator in patients with either mCSPC or nmCRPC, and depth and speed of PSA decline were significantly improved with apalutamide treatment.”

The percentage of patients with mCSPC who experienced a PSA decline of ≥50% or ≥90% or with an undetectable PSA (<0.2ng/mL) was approximately 3 times higher for those treated with apalutamide in combination with ADT compared to patients receiving ADT alone. No PSA decline was observed for patients with nmCRPC treated with ADT alone, but the combination therapy demonstrated a significant decline in PSA, including undetectable levels in a significant portion of patients, according to the investigators.

In the study, faster and more significant declines in PSA were correlated with an increased length of overall survival. Further, median time to deep PSA decline—defined as ≥90% from baseline and/or a PSA nadir of ≤0.2 ng/mL—was observed to be more rapid for the combination therapy of apalutamide and ADT than previously reported for other therapies.

“Outside of a clinical trial setting, health care professionals are focused on ensuring a therapy can benefit patients treated in the real world,” said Benjamin Lowentritt, MD, director of the Prostate Cancer Care Program at Chesapeake Urology, in the release “To have both high adherence rates and robust PSA reductions is very encouraging. These findings support the use of apalutamide in delaying disease progression and metastasis in patients with nmCRPC across various demographics.”

REFERENCE

Erleada® (apalutamide) oral presentations demonstrate importance of prostate specific antigen (PSA) as key efficacy indicator and show strong patient adherence rates [news release]. Johnson & Johnson; September 11, 2021. Accessed September 15, 2021. https://www.jnj.com/erleada-apalutamide-oral-presentations-demonstrate-importance-of-prostate-specific-antigen-psa-as-key-efficacy-indicator-and-show-strong-patient-adherence-rates