New ERLEADA (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Feb 16, 2022 01:51
CST Updated
01:51
Johnson & Johnson
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Janssen Pharmaceuticals
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Prostate Cancer (Image Source: hopkinsmedicine.org)
News on February 15, 2022 /BioValleyBIOON/ -- Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceuticals recently in the United States clinicalTumorNew real-world evidence data was presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), showing:In patients with metastatic castration-sensitive prostate cancer (mCSPC), initiation of Erleada (Ansenke®, generic name: apalutamide) treatment led to a high rate of rapid and deep prostate-specific antigen (PSA) response.. In separate post-hoc analyses of the Phase 3 SPARTAN and TITAN registration studies,The rapid and deep PSA response of Erleada is associated with improvements in patient-reported outcomes (PROs) related to quality of life, physical health, pain, and fatigue intensity.
Erleada is a new generation androgen receptor (AR) inhibitor that can help block the activity of male hormones (such as testosterone), delaying disease progression. In terms of prostate cancer, Erleada has been approved for two indications: treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). These two indications have been approved in China.
Real-world evidence study evaluating PSA response included data from 186 patients treated with Erleada and 165 patients treated with Xtandi (enzalutamide) across 69 community urology clinics in the United States. By 6 months,69.3% of patients treated with Erleada achieved a PSA90 response, while 55.6% of patients treated with Xtandi reached a PSA90 response (HR=1.56; p=0.014).A PSA90 response is defined as a ≥90% decline in PSA levels from baseline after initiating treatment. At 9 months and the end of follow-up, 70.4% of patients treated with Erleada achieved a PSA90 response, compared to 62.5% of patients treated with Xtandi (HR=1.49; p=0.024).The median time to achieve a PSA90 response in patients treated with Erleada was 3.1 months, compared to 5.2 months for patients treated with Xtandi.。
A deep PSA response is an important early prognostic factor that can lead to longer progression-free survival and overall survival in patients with mCSPC. These real-world data are consistent withClinical TrialThe benefits of Erleada reported in the environment are consistent and reinforce its advantages, providing prescribing physicians with important insights into the timing and durability of the PSA90 response for commonly prescribed mCSPC medications.
In addition, an independent post-hoc analysis of patient-reported outcomes (PRO) from the Phase 3 SPARTAN and TITAN studies indicated thatRapid, deep declines in PSA are associated with improved health-related quality of life in patients with advanced prostate cancer.(Bioon.com)