ESTABLISHED SAFETY PROFILE1-3

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INCIDENCE OF ADVERSE REACTIONS1

Adverse Reactions (All Grades) With ≥10% Incidence in the ERLEADA® + ADT Arm That Occurred With at Least 2% Greater Frequency Than in the Placebo + ADT Arm in the TITAN Study1

Adverse Reactions ERLEADA® + ADT (n=524) Placebo + ADT (n=527)
Rash 28% 9%
Hot flush 23% 16%
Hypertension 18% 16%
Arthralgia 17% 15%
Pruritus 11% 4.6%

Grades 3 and 4 Adverse Reactions in the TITAN Study1

Adverse Reactions ERLEADA® + ADT (n=524) Placebo + ADT (n=527)
Hypertension 8% 9%
Rash 6% 0.6%
Pruritus 0.2% 0.2%
Arthralgia 0.4% 0.9%
Hot flush 0% 0%

Serious adverse reactions occurred in 20% of patients in the ERLEADA® + ADT arm and 20% of patients in the placebo + ADT arm.1 The discontinuation rate due to adverse reactions was 8% in the ERLEADA® + ADT arm.1

In the combined data of 2 randomized, placebo-controlled clinical studies, rash associated with ERLEADA® was most commonly described as macular or maculopapular. The onset of rash occurred at a median of 83 days of ERLEADA® treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash.1

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INCIDENCE OF ADVERSE REACTIONS1

Adverse Reactions (All Grades) With ≥10% Incidence in the ERLEADA® + ADT Arm That Occurred With at Least 2% Greater Frequency Than in the Placebo + ADT Arm in the SPARTAN Study1

Adverse Reactions ERLEADA® + ADT (n=803) Placebo + ADT (n=398)
Fatigue 39% 28%
Hypertension 25% 20%
Rash 25% 6%
Diarrhea 20% 15%
Nausea 18% 16%
Weight decreased 16% 6%
Arthralgia 16% 8%
Fall 16% 9%
Hot flush 14% 9%
Decreased appetite 12% 9%
Fracture 12% 7%
Peripheral edema 11% 9%

Grades 3 and 4 Adverse Reactions in the SPARTAN Study1

Adverse Reactions ERLEADA® + ADT (n=803) Placebo + ADT (n=398)
Hypertension 14% 12%
Rash 5.2% 0.3%
Fracture 2.7% 0.8%
Fall 1.7% 0.8%
Weight decreased 1.1% 0.3%
Diarrhea 1.1% 0.5%
Fatigue 1.4% 0.3%
Decreased appetite 0.1% 0%
Arthralgia 0% 0%
Hot flush 0% 0%
Nausea 0% 0%
Peripheral edema 0% 0%

In the SPARTAN study, 25% of patients in the ERLEADA® + ADT arm experienced serious adverse reactions and 23% of patients in the placebo + ADT arm.1

In the combined data of 2 randomized, placebo-controlled clinical studies, rash associated with ERLEADA® was most commonly described as macular or maculopapular. The onset of rash occurred at a median of 83 days of ERLEADA® treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash.1

ADDITIONAL SAFETY INFORMATION IN THE SPARTAN STUDY

To evaluate the potential effect of ERLEADA® on cognitive deficits, events of amnesia, cognitive disorder, memory impairment, and disturbance in attention were assessed.2,3

Additional Safety Information in the SPARTAN Study2,3

Treatment-Emergent Adverse Events

ERLEADA® + ADT (n = 803)

Placebo + ADT (n=398)

Any mental impairment disorder* 3.9% 3.4%
Amnesia 1.9% 1.0%
Memory impairment 1.6% 1.5%
Disturbance in attention 1.2% 0.3%
Cognitive disorder 0.7% 0.8%

*All mental impairment disorders were Grades 1 or 2.

Exposure-adjusted rate. An exposure-adjusted rate is 100 times the number of distinct mental impairment disorder treatment-emergent adverse events divided by total years of exposure.

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Patient-reported outcomes for health-related quality of life

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ADT = androgen deprivation therapy; AE = adverse event; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509; TEAEs = treatment-emergent adverse events; TITAN = Targeted Investigational Treatment Analysis of Novel Anti-androgen.

REFERENCES:

  1. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.
  3. U.S. Food and Drug Administration. Drug Approval Package: ERLEADA® (apalutamide). SPARTAN Clinical Study Report. Accessed December 22, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/rev_210951_arn-509-003_CSR_Redacted.pdf