Apalutamide Reduces Risk of PSA Progression by 94% in Nonmetastatic CRPC

Excerpt:

“Apalutamide (Erleada) lowered the risk of PSA progression by 94% in patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to a posthoc analysis from the phase III SPARTAN trial presented at the 2018 American Urological Association (AUA) Annual Meeting.

“The median time to PSA progression was not reached in the apalutamide arm compared with 3.71 months in the placebo group (HR, 0.064; 95% CI, 0.052-0.080; <.0001). A separate retrospective cohort study presented at AUA underscored the significance of these apalutamide data by confirming prior observations of the link between faster PSA doubling time (PSADT) and poorer metastasis-free survival (MFS) and overall survival (OS).”

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Researchers Create a Drug to Extend the Lives of Men with Prostate Cancer

Excerpt:

“Fifteen years ago, Michael Jung was already an eminent scientist when his wife asked him a question that would change his career, and extend the lives of many men with a particularly lethal form of prostate cancer.

” ‘When I turned 55—I’m now 70—my wife, Alice, said to me, “What do you want to do for the rest of your life, more of the same?” ‘ recalled Jung, a UCLA distinguished professor of chemistry and biochemistry. ‘I said that didn’t sound like such a bad idea until you put it that way.’ ”

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Apalutamide, Enzalutamide Improve Metastasis-Free Survival in Nonmetastatic Castrate-Resistant Prostate Cancer

Excerpt:

In two separate trials presented at the 2018 Genitourinary Cancers Symposium, apalutamide and enzalutamide (Xtandi), respectively, reduced the risk of metastasis and prolonged metastasis-free survival in men with high-risk nonmetastatic castrate-resistant prostate cancer. In the SPARTAN trial, apalutamide reduced the risk of developing metastasis and death by 72% compared with placebo, and in the PROSPER trial, enzalutamide reduced the risk of metastasis or death by 71% compared with placebo. In both studies, men were treated with ongoing androgen-deprivation therapy.”

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FDA Approves New Treatment for a Certain Type of Prostate Cancer Using Novel Clinical Trial Endpoint

Excerpt:

“The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.”

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Strong Data Lift Profile of J&J’s Cancer Drug Apalutamide

Excerpt:

“Adding Johnson & Johnson’s experimental prostate cancer drug apalutamide to standard treatment helped delay the development of metastases in patients with non-metastatic castration-resistant disease by just over 2 years, results from a Phase 3 study showed.”

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Apalutamide Granted FDA’s Priority Review for Nonmetastatic CRPC

Excerpt:

“Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

“The trial evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The primary endpoint of the study is metastasis-free survival.”

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Apalutamide Granted FDA’s Priority Review for Nonmetastatic CRPC

Excerpt:

“Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

“The trial evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The primary endpoint of the study is metastasis-free survival.”

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Apalutamide Submitted for FDA Approval in Prostate Cancer

Excerpt:

“Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), the manufacturer of the next-generation oral androgen receptor inhibitor announced today.

“Apalutamide inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, Janssen noted in a press release.”

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Second-Generation AR-Targeting Agent Explored in High-Risk Prostate Cancer

Excerpt:

“Researchers are hoping the results of a late-stage efficacy and safety study of apalutamide (ARN-509) in patients with high-risk, localized, or locally advanced prostate cancer who are receiving primary radiation therapy will demonstrate an improvement in metastasis-free survival, according to global principal investigator, Howard M. Sandler, MD.

“ ‘The patient population that we’re studying are men who are at risk of dying of prostate cancer,’ Sandler, chair of the Department of Radiation Oncology at Cedars-Sinai Medical Center in Los Angeles, told OncologyLive. ‘If we can provide better upfront disease control, we’re hoping to reduce the number of men who enter into the castrate-resistant prostate cancer stage.’ “

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