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Darolutamide lowers risk of death by 31% for some prostate-cancer patients

New England Journal of Medicine
Reuters Health - 09/09/2020 - The new prostate-cancer drug darolutamide lowers the risk of death by 31% at the three-year mark for men with nonmetastatic, castration-resistant prostate cancer, according to new data from the phase-3 ARAMIS study.

Finland's Orino and Germany's Bayer, which paid for the test, had previously announced that the drug, sold under the brand name Nubeqa, had produced a median metastasis-free survival of 40.4 months versus 18.4 months with placebo.

The new report, in the New England Journal of Medicine, says that overall survival at three years was 83% with the drug versus 77% with placebo (P=0.003).

The drug is given in conjunction with androgen-deprivation therapy.

The study involved 1,509 men, all with a PSA doubling time of 10 months or less. The metastasis-free survival data served as the basis for the drug's approval by the U.S. Food and Drug Administration in July 2019.

The time to pain progression, a secondary end point, was 40.3 months with darolutamide and 25.4 months with placebo (P<0.001)

The treatment carries a price tag of more than $11,000 per month, according to prices on goodrx.com.

Darolutamide is an androgen-receptor inhibitor. It was not compared to other treatments marketed by Astellas, Pfizer and Johnson and Johnson.

Side effects were comparable in both groups, but fatigue was more common with darolutamide, seen in 13.2% versus 8.3% with placebo. All other side effects were seen in fewer than 10% of patients.

"The incidence of adverse events commonly associated with androgen-receptor inhibitors, including falls, seizures, mental-impairment disorders, and hypertension, was similar in the two groups," said the team, led by Dr. Karim Fizazi of the University of Paris-Saclay. "The incidence of fractures was slightly higher in the darolutamide group than in the placebo group; however, after adjustment for the duration of exposure, the between-group difference decreased."

According to a 2014 deal, Bayer has the right to commercialize darolutamide globally while Orion will manufacture the product and receive milestone payments upon first sale in different markets.

Nonmetastatic, castration-resistant prostate cancer occurs in about 15,000 of the 160,000 new cases of prostate cancer diagnosed annually in the U.S.

By Reuters Staff

SOURCE: https://bit.ly/2F2rWBO The New England Journal of Medicine, online September 9, 2020.

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