Erleada analysis demonstrates rapid, deep prostate-specific antigen (PSA) response in metastatic castration-sensitive prostate cancer.

In a separate post-hoc analysis of the registrational Phase III SPARTAN and TITAN studies, rapid and deep PSA responses with Erleada were associated with improvement in patient-reported outcomes (PROs) related to quality of life, physical wellbeing, pain, and fatigue intensity. These findings were presented during the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium, in San Francisco and virtually from February 17-19, 2022.

The real-world evidence study evaluating PSA response (Abstract 43, Poster B9) included data from 186 patients treated with Erleada and 165 treated with enzalutamide from 69 community urology practices in the United States. By six months, 69.3 percent of patients with mCSPC initiated on Erleada attained PSA90 response and 55.6 percent for enzalutamide (HR=1.56; p=0.014). PSA90 response is defined as the patient’s earliest attainment of greater than 90 percent decline in PSA relative to their baseline PSA at treatment initiation. At nine months and by the end of follow-up, 70.4 percent of patients treated with Erleada achieved PSA90 and 62.5 percent for enzalutamide (HR=1.49; p=0.024). The median time to PSA90 response was 3.1 months for patients treated with Erleada and to 5.2 months for enzalutamide.

“Deep PSA response is an important early prognostic factor for achieving longer radiographic progression-free survival and overall survival in patients with metastatic castration-sensitive prostate cancer,” said Benjamin Lowentritt, M.D., Director Prostate Cancer Care Program, Chesapeake Urology, and Past President, AUA, Mid-Atlantic Region, and lead study investigator. “These real-world data are consistent with and reinforce the benefit of Erleada as reported in the clinical trial setting, providing prescribers with important insights regarding time to and durability of PSA90 responses for commonly prescribed mCSPC medications.”

Patients included in the analysis had at least 12 months of clinical activity to assess baseline characteristics and were classified into treatment cohorts based on their first filled prescription for Erleada or enzalutamide after Dec. 16, 2019. Patients were followed from their first filled prescription date until the earliest of one of the following events: regimen discontinuation, treatment switch, end of clinical activity or end of data availability (March 5, 2021).

A separate Erleada poster presentation evaluating PROs data (Abstract 73, Poster D1) demonstrated an association between rapid and deep PSA decline and improved health-related quality of life PROs as reported from the Phase III SPARTAN and TITAN studies. Patient-reported outcomes were assessed using tools including the Functional Assessment of Cancer Therapy-Prostate (FACT-P; TITAN and SPARTAN), Brief Pain Inventory-Short Form (BPI-SF; TITAN only), and Brief Fatigue Inventory (BFI; TITAN only).

A landmark analysis at three months after treatment initiation evaluated the association between deep PSA decline ( less than 0.2 ng/mL) and delay in deterioration in PROs (defined as decrease greater than 10 points FACT-P total, greater than 3 points Physical Wellbeing, greater than 30 percent baseline for BPI-SF worst pain, or greater than 2 points for BFI worst fatigue). Patients in both studies who achieved a deep PSA decline maintained FACT-P total (SPARTAN: HR=0.83; TITAN: HR=0.54) or FACT-P Physical Wellbeing (SPARTAN: HR=0.70; TITAN: HR=0.63) levels longer. Patients in TITAN who achieved a deep PSA decline had a lower risk of increasing pain or worsening fatigue; as assessed by the BPI-SF worst pain intensity progression (HR=0.70) or BFI worst fatigue intensity progression (HR=0.76), respectively.

“This analysis demonstrates that the rapid and deep PSA responses shown in the SPARTAN and TITAN pivotal studies translate into improved quality of life for patients,” said Tracy McGowan, M.D., Therapeutic Area Head, U.S. Medical Affairs, Janssen Scientific Affairs, LLC. “We are dedicated to continually expanding the body of research for Erleada by providing important information that may help patients and their physicians make treatment decisions that work best for them.”

To date, published results on Erleada include data from more than 2,000 patients across three Phase III clinical studies. Erleada has shown a statistically significant improvement in overall survival with a consistent safety profile, while maintaining patients’ health-related quality of life in both approved indications of mCSPC and non-metastatic castration resistant prostate cancer (nmCRPC). Erleada is currently approved in more than 74 countries.