Elzonris (Page 4 of 5)

14 CLINICAL STUDIES

14.1 First-Line Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

STML-401-0114 (NCT 02113982; Study 0114) was a multicenter, open-label, single-arm, clinical trial that included a prospective cohort of 13 patients with treatment-naive BPDCN. Treatment consisted of ELZONRIS 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-day cycle. Patient baseline characteristics are presented in Table 5.

Table 5. Baseline Demographics of Patients with Treatment-Naive BPDCN
Parameter N=13
Gender, N (%)
Male 11 (84.6)
Female 2 (15.4)
Age (years), N (%)
Median 65.0
Minimum, Maximum 22, 84
ECOG, N (%)
0 8 (61.5)
1 5 (38.5)
BPDCN at Baseline, N (%)
Skin 13 (100.0)
Bone Marrow 7 (53.8)
Peripheral Blood 3 (23.1)
Lymph Nodes 6 (46.2)
Viscera 2 (15.4)

The efficacy of ELZONRIS in patients with treatment-naive BPDCN was based on the rate of complete response or clinical complete response (CR/CRc). Key efficacy measures are presented in Table 6. The median time to CR/CRc was 57 days (range: 14 to 107).

Table 6. Efficacy Measures in Patients with Treatment-Naive BPDCN

* CRc is defined as complete response with residual skin abnormality not indicative of active disease.

Parameter N=13
CR/CRc* Rate, N (%) 7 (53.8)
(95% CI) (25.1, 80.8)
Duration of CR/CRc (months)
Median Not Reached
Minimum, Maximum 3.9, 12.2
Duration of follow up (months)
Median 11.5
Minimum, Maximum 0.2, 12.7

14.2 Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

STML-401-0114 (NCT02113982; Study 0114) was a multicenter, open-label, single-arm, clinical trial that included 15 patients with relapsed or refractory BPDCN. Treatment consisted of ELZONRIS 12 mcg/kg on days 1 to 5 of each 21-day cycle. Patient baseline characteristics are presented in Table 7.

Table 7. Baseline Demographics of Patients with Relapsed or Refractory BPDCN
Parameter (N=15)
Gender, N (%)
Male 13 (86.7)
Female 2 (13.3)
Age (years)
Median 72
Minimum, Maximum 44, 80
ECOG, N (%)
0 5 (33.3)
1 10 (66.7)
BPDCN at Baseline, N (%)
Skin 13 (86.7)
Bone marrow 9 (60.0)
Lymph node 8 (53.3)
Visceral 4 (26.7)
Peripheral blood 1 (6.7)

In the 15 patients with relapsed/refractory BPDCN, one patient achieved a CR (duration: 111 days) and one patient achieved a CRc (duration: 424 days).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ELZONRIS (tagraxofusp-erzs) injection is a preservative-free, sterile, clear, colorless, 1,000 mcg in 1 mL solution supplied in a single-dose glass vial. Each carton contains one vial (NDC 72187-0401-1).

16.2 Storage and Handling

Store in freezer between -25°C and -15°C (-13°F and 5°F). Protect ELZONRIS from light by storing in the original package until time of use. Thaw vials at room temperature between 15°C and 25°C (59°F and 77°F) prior to preparation [see Preparation for Administration (2.3)]. Do not refreeze the vial once thawed. Do not use beyond expiration date on container.

17 PATIENT COUNSELING INFORMATION

Capillary Leak Syndrome

Advise patients of the risk of capillary leak syndrome (CLS), and to contact their health care professional for signs and symptoms associated with CLS including new or worsening edema, weight gain, shortness of breath, and/or hypotension after infusion. Advise patients to weigh themselves daily [see Warnings and Precautions (5.1)].

Hypersensitivity

Advise patients of the risk of hypersensitivity reactions, and to contact their healthcare professional for signs and symptoms associated with hypersensitivity reactions including rash, flushing, wheezing and swelling of the face [see Warnings and Precautions (5.2)].

Hepatic Toxicity

Advise patients to report symptoms that may indicate elevated liver enzymes including fatigue, anorexia and/or right upper abdominal discomfort [see Warnings and Precautions (5.3)].

Contraception

Advise females to avoid pregnancy and to use acceptable contraceptive methods during ELZONRIS treatment and for at least 1 week after the last dose of ELZONRIS.

Lactation

Advise women not to breastfeed [see Use in Specific Populations (8.2)].

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Stemline Therapeutics, Inc.
New York, NY 10022 US License No. 2088

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