ESTABLISHED SAFETY PROFILE1-4
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% |
Additional Safety Information in the TITAN Study2
|
Treatment-Emergent Adverse Events |
ERLEADA® + ADT (n=524) | Placebo + ADT (n=527) |
|---|---|---|
| Any mental impairment disorder | 2.7% | 1.5% |
| Memory impairment | 1.3% | 1.1% |
| Amnesia | 0.8% | 0.2% |
| Cognitive disorder | 0.8% | 0.2% |
| Disturbance in attention | 0.2% | 0.2% |
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
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% |
Additional Safety Information in the SPARTAN Study3,4
|
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% |
To evaluate the potential effect of ERLEADA® on cognitive deficits, events of amnesia, cognitive disorder, memory impairment, and disturbance in attention were assessed.3,4
*All mental impairment disorders were Grades 1 or 2.4
†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.4
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
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:
- ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Data on file. Janssen Biotech, Inc.
- 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.
- 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