Safety was assessed in1:
-
94 adult patients with newly diagnosed or relapsed/refractory myeloid malignancies*
- 58 patients had BPDCN
- All patients received 12 mcg/kg
-
The overall median number of cycles administered for patients evaluated for safety was 2 (range, 1-43 cycles; N=94)1*
- The median number of cycles administered for patients with BPDCN was 4 (range, 1-43 cycles; N=58)
- Two (2%) patients had a fatal adverse reaction, both capillary leak syndrome (CLS)
- Overall, 10 (11%) patients discontinued treatment with ELZONRIS due to an adverse reaction; the most common adverse reactions resulting in treatment discontinuation were hepatic toxicities and CLS
Adverse reactions in ≥ 10% of patients receiving 12 mcg/kg of ELZONRIS1
N=94 | ||
---|---|---|
All grades % | Grade ≥ 3 % | |
Capillary leak syndromea | 55 | 9 |
Nausea | 49 | 0 |
Fatigue | 45 | 7 |
Peripheral edema | 43 | 1 |
Pyrexia | 43 | 0 |
Weight increase | 31 | 0 |
Chills | 29 | 1 |
Headache | 29 | 0 |
Hypotension | 29 | 9 |
Decreased appetite | 24 | 0 |
Constipation | 23 | 0 |
Vomiting | 21 | 0 |
Back pain | 20 | 2 |
Diarrhea | 20 | 0 |
Dizziness | 20 | 0 |
Febrile neutropenia | 20 | 18 |
Dyspnea | 19 | 2 |
Insomnia | 17 | 0 |
Tachycardia | 17 | 0 |
Anxiety | 15 | 0 |
Hypertension | 15 | 6 |
Cough | 14 | 0 |
Epistaxis | 14 | 1 |
Oropharyngeal pain | 12 | 0 |
Confusional state | 11 | 0 |
Hematuria | 10 | 0 |
Pain in extremity | 10 | 2 |
Petechiae | 10 | 0 |
Pruritus | 10 | 0 |
aCapillary leak syndrome (CLS) defined as any event reported as CLS during treatment with ELZONRIS or the occurrence of at least 2 of the following CLS manifestations within 7 days of each other: hypoalbuminemia (including albumin value less than 3.0 g/dL), edema (including weight increase of 5 kg or more), hypotension (including systolic blood pressure less than 90 mmHg).1
*This population included patients with acute myeloid leukemia.2
- References:
- ELZONRIS [prescribing information]. New York, NY, US: Stemline Therapeutics, Inc.; December 2018.
- Data on file. Stemline Therapeutics, Inc.