The Impact of Apalutamide Approval on the CSPC Landscape

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EP: 1.The Impact of Apalutamide Approval on the CSPC Landscape

EP: 2.TITAN Trial Finds Survival Benefit for Apalutamide in mCSPC

EP: 3.Monitoring Responses to Novel Hormonal Agents in Metastatic CSPC

EP: 4.Part 1: Reviewing the Systemic Therapy Options for Metastatic CSPC

EP: 5.Part 2: Updated Results Show Long-Term Survival Benefit for Apalutamide in mCSPC

EP: 6.Counseling Patients on Systemic Therapy for Metastatic CSPC

EP: 7.Treating mCSPC with Anti-Androgen Therapy and Monitoring for Progression

Daniel P. Petrylak, MD, professor of medicine and urology and coleader of Cancer Signaling Networks at Yale Cancer Center, discusses the impact of the approval of apalutamide (Erleada) in the metastatic castration-sensitive prostate cancer (mCSPC) setting.

Apalutamide is an antiandrogen drug that was approved by the FDA for treatment of patients with mCSPC in September 2019, having previously been approved for metastatic castration-resistant prostate cancer in 2018.

The randomized phase 3 TITAN trial (NCT02489318) of apalutamide demonstrated that 240 mg daily of apalutamide plus androgen deprivation therapy reduced the risk of death in patients with mCSPC by 35% compared with a placebo. It also delayed second progression-free survival and castration resistance.

Compared with abiraterone (Zytiga) and enzalutamide (Xtandi), which are also approved for mCSPC, apalutamide may have less central nervous system (CNS) toxicity, and is less likely to cause fatigue, according to Petrylak. Apalutamide also does not require corticosteroids, while abiraterone is generally given with prednisone.

TRANSCRIPTION:

0:08 | Given the fact that the survival benefits all appear to be about the same, apalutamide will reduce the risk of death by 33% in patients with CSPC and also reduce the risk of radiographic progression by [52%]. And that's within the same order of magnitude of the other drugs. One of the things I like to look at is toxicity. Apalutamide may have less CNS toxicity than other agents. That gives us an advantage over other drugs, particularly that we know that drugs like enzalutamide and abiraterone can cause fatigue. Also, compared to abiraterone, you don't need to use steroids, and that can be a problem in some patients. So there are a number of advantages that could occur based upon the [adverse event] profiles of each of these drugs.