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David Morris, MD, FACS, discusses overall survival data with apalutamide in prostate cancer.
David Morris, MD, FACS, a urologist at Urology Associates, P.C., discusses overall survival (OS) data with apalutamide (Erleada) in prostate cancer.
Trials examining antiandrogen agents, such as apalutamide, in patients with nonmetastatic castration-resistant prostate cancer were initially powered for metastasis-free survival, says Morris. However, there has been a lot of interest regarding secondary outcomes with these agents, such as OS, explains Morris. The first round of data cuts from all trials showed a trend for OS, but did not reach any statistical significance.
At the 2019 ESMO Congress, updated data with apalutamide showed a further trend to significance but did not yet cross the P value that was required for statistical significance, says Morris. However, the trial favored active drug therapy versus placebo with a median follow-up of up to 41 months, therefore providing support for the idea that these agents will likely show OS benefit if they continue to be followed for enough events, concludes Morris.