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_t.... Accessed September 24, 2019.

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.