ERLEADA® Plus ADT Post-Prostatectomy: 100% Biochemical Recurrence-Free Outcome in High-Risk Patients

A recent study presents a promising opportunity to enhance treatment for high-risk localized prostate cancer (HRLPC) patients, revealing that approximately half of such individuals experience disease recurrence within two years post-surgery.

In a statement from May 3, 2024, Johnson & Johnson unveiled findings from the Apa-RP Phase 2 study, which assessed the efficacy of ERLEADA® (apalutamide) coupled with androgen deprivation therapy (ADT) following radical prostatectomy (RP). The investigation, conducted in an open-label, single-arm format, observed a 100% biochemical recurrence (BCR)-free rate over a 24-month period. These compelling results were shared during an oral presentation at the American Urological Association's Annual Meeting in San Antonio, Texas, held from May 3-6, 2024.

Dr. Neal Shore, Chairman of the Steering Committee and Chief Medical Officer for Genesis Care's Surgical Oncology and Urology departments, remarked on the significant potential these findings hold. Dr. Shore emphasized that integrating apalutamide with ADT post-RP could significantly benefit HRLPC patients by reducing the likelihood of progression to metastatic prostate cancer. The study's positive outcomes encourage ongoing research into early treatment interventions.

The Apa-RP study met its primary goal, demonstrating that a 12-month regimen of ERLEADA® and ADT after RP resulted in no confirmed BCR following an additional year of observation. Testosterone recovery rates were registered at 76.4% at the 12-month marker. Safety profiles for ERLEADA® in conjunction with ADT remained consistent with prior reports, with treatment-emergent adverse events (TEAEs) affecting 99.1% of participants, 22.2% of which were categorized as grade 3-4.

Dr. Luca Dezzani, Vice President of Medical Affairs for Solid Tumor at Johnson & Johnson Innovative Medicine, highlighted the persistent challenge: despite advancements, 50% of HRLPC patients face recurrence within two years post-RP, underscoring the urgent need for innovative treatments that mitigate long-term risks. Dr. Dezzani emphasized the significance of studies like Apa-RP and the ongoing evaluation of ERLEADA® in understanding earlier intervention's potential to improve patient outcomes.

Prostate cancer diagnoses in the U.S. tally up to about 300,000 annually, with 40% of patients classified as high-risk. Notably, up to half these patients experience recurrence within a decade post-surgery, presenting a substantial risk of disease progression and mortality.

The multicenter Apa-RP Phase 2 study (NCT04523207) involved 108 treatment-naïve HRLPC patients from 32 U.S. urology practices who had undergone RP. Participants were administered ERLEADA® (240 mg daily) for 12 cycles (each cycle comprising 28 days) alongside 12 months of ADT. The primary endpoint assessed BCR-free rates, defined by two sequential PSA levels of <=0.2 ng/mL, while secondary endpoints included testosterone recovery rates and safety.

ERLEADA® (apalutamide) is endorsed for treating non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Approved by the FDA for nmCRPC in February 2018 and mCSPC in September 2019, ERLEADA® is under evaluation in additional studies for treating localized high-risk or advanced prostate cancer.

The innovative approaches tested in this study reflect Johnson & Johnson's broader commitment to advancing healthcare solutions and improving outcomes for patients facing high-risk prostate cancer.