Apalutamide product info, just an FYI

[Darryl]

I got an email with the following regarding Apalutamide, so I thought to post and share.

MECHANISM OF ACTIONApalutamide is a second generation androgen receptor inhibitor

INDICATIONApalutamide indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

STUDY DESIGN & POPULATIONA global randomized double-blind, placebo-controlled Phase III trial (n=1,207) evaluating Apalutamide vs. placebo in nmCRPC patients at high risk for developing metastases (as defined by PSA doubling-time of ≤10 months and PSA above 2ng/mL):

No prior chemotherapy, immunotherapy, second generation AR antagonist, or CYP17A inhibitor

Ongoing androgen deprivation therapy (ADT) or prior orchiectomy

ECOG 0 or 1

M0 is determined by using bone scan, MRI, and/or CT

DOSING & ADMINISTRATIONApalutamide capsules x 4, administered once daily

PRIMARY ENDPOINTMetastasis-free survival (MFS): 40.5 months for apalutamide vs. 16 months for placebo (increase of 24 months); HR 0.28, p < 0.0001)

OS SECONDARY ENDPOINTOverall survival (OS) data were not mature at the time of final MFS analysis but show a positive trend in OS improvement for apalutamide vs placebo

OTHER SECONDARY EFFICACY ENDPOINTSStatistically significant improvement in time to metastases, progression-free survival, and time to symptomatic progression.

QUALITY OF LIFENo difference between apalutamide and placebo in the time to deterioration in health-related QOL measured by FACT-P and EQ-5D

SAFETYIncidence of All AEs (Apalutamide vs. placebo)

Diarrhea: 20% vs 15%

Nausea: 18% vs 15.8%

Rash: 23.8% vs 5.5%

Fracture: 11.7% vs 6.5%

Hypertension: 24.8% vs 19.8%

Dizziness: 9.3% vs 6.3%

Fall: 15.6% vs 9.0%

Fatigue: 30.4% vs 21.1%

Seizures/convulsions: 0.2% (2 pts.) vs 0%

Mental impairment: 5.1% vs 3.0%

Additional DataIncreased incidence of seizures stated in the Prescribing Information Warning & Precautions section.

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Again, thanks for this post Darryl.

[lakersfan]

Hi Darryl, thanks for the post. I'm trying to learn a bit about the marketing of drugs for PC. Was this email straight from the manufacturer, or some 3rd party? Also, is this United States-based, or coming from a different country. Thanks for the help!

[Darryl Partner in reply to lakersfan]

Hi I received the email over three months ago...I'm sorry not to have answers to your questions.

[lakersfan in reply to Darryl]

It's ok, thanks for the quick response!