Safety in nmCRPC
Established safety profile1
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% | 0.3% |
| Fracture | 3% | 0.8% |
| Fall | 2% | 0.8% |
| Weight decreased | 1% | 0.3% |
| Diarrhea | 1% | 0.5% |
| Fatigue | 1% | 0.3% |
| Decreased appetite | 0.1% | 0% |
| Arthralgia | 0% | 0% |
| Hot flush | 0% | 0% |
| Nausea | 0% | 0% |
| Peripheral edema | 0% | 0% |
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 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% |
To evaluate the potential effect of ERLEADA® on cognitive deficits, events of amnesia, cognitive disorder, memory impairment, and disturbance in attention were assessed.2
*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.
ADT = androgen deprivation therapy; nmCRPC = non-metastatic castration-resistant prostate cancer; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.
References
1. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
2. U.S. Food and Drug Administration. Drug Approval Package: ERLEADA® (apalutamide). SPARTAN Clinical Study Report. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm. Accessed August 14, 2020.
3. Smith MR, Saad F, Chowdhury S, et al; for the SPARTAN Investigators. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.
