This site is intended for US Healthcare Professionals only.
close

After ~3 Years Median Follow-up

Demonstrated long-term efficacy with ELZONRIS1

Long-term safety and efficacy of ELZONRIS, the first and only targeted FDA-approved treatment for BPDCN, were evaluated in the long-term analysis, which included all patients from the initial analysis and those enrolled in the continued access cohort.1

The primary outcome of the study was the combined rate of CR and CRc among treatment-naive patients. All other data presented here were secondary outcomes.2,3


The primary outcome was CR/CRc1

Long-term analysis

  • The long-term analysis included all 44 patients from the initial analysis, as well as 40 others enrolled in the continued access cohort1,3,4

    • 65 treatment-naive patients and 19 previously treated patients were efficacy evaluable1
  • Patients with CR/CRc received ELZONRIS until disease progression, unacceptable toxicity, or allogeneic (allo)/autologous (auto) SCT2,5
  • Median follow-up was ~3 years1

Long-term efficacy of ELZONRIS in treatment-naive patients with BPDCN

Data from the largest prospective study to date in treatment-naive patients with BPDCN (n=65) with a median follow-up of ~3 years1,2

Long Term 57 Long Term 57
Long Term 51
Long term 16 weeks Long Term 2 years Long Term 34 months

Explore the baseline characteristics of treatment-naive patients in the long-term analysis

Baseline characteristics of treatment-naive patients1

Characteristics Long-term analysis
(n=65)
Male, % (n) 80% (52)
Female, % (n) 20% (13)
Median age
(min, max)		 68 (22, 84)
ECOG PS, % (n)
0 48% (31)
1 48% (31)
BPDCN, % (n)
Skin 92% (60)
Bone marrow 49% (32)
Peripheral blood 26% (17)
Lymph nodes 51% (33)
Visceral 14% (9)

ECOG PS, Eastern Cooperative Oncology Group performance status.

Long-term efficacy of ELZONRIS in previously treated patients with BPDCN

In previously treated patients with BPDCN (n=19) who were efficacy evaluable, ORR was 58% (95% CI, 33.5 to 79.7) with 1 patient achieving CR and 2 patients achieving CRc.1

Explore the baseline characteristics of previously treated patients in the long-term analysis

Baseline characteristics of previously treated patients1,2

Characteristics Long-term analysis
(n=19)
Male, % (n) 84% (16)
Female, % (n) 16% (3)
Median age
(min, max)		 72 (44, 87)
ECOG PS, % (n)
0 37% (7)
1 63% (12)
BPDCN, % (n)
Skin 79% (15)
Bone marrow 63% (12)
Peripheral blood 5% (1)
Lymph nodes 47% (9)
Visceral 21% (4)
Prior treatments, % (n)
Radiation therapy 32% (6)
Stem cell transplantation 32% (6)

ECOG PS, Eastern Cooperative Oncology Group performance status.

*n=19/37.

BPDCN, blastic plasmacytoid dendritic cell neoplasm; CI, confidence interval; CR, complete response; CRc, CR with residual skin abnormalities not indicative of the active disease; NR, not reached; ORR, overall response rate; SCT, stem cell transplant.

View safety results in patients with myeloid malignancies receiving ELZONRIS
  1. References:
  2. Pemmaraju N, et al. Long-term benefits of tagraxofusp for patients with blastic plasmacytoid dendritic cell neoplasm. J Clin Oncol. 2022;40(26):3032-3036.
  3. Data on file. Stemline Therapeutics, Inc.
  4. Pemmaraju N, et al. Tagraxofusp in blastic plasmacytoid dendritic-cell neoplasm. N Engl J Med. 2019;380(17):1628-1637.
  5. Pemmaraju N, et al. Long-term benefits of tagraxofusp for patients with blastic plasmacytoid dendritic cell neoplasm. J Clin Oncol. 2022;40(26):3032-3036 [supplementary appendix].
  6. ELZONRIS [prescribing information]. New York, NY: Stemline Therapeutics, Inc.; November 2022.

INDICATION

  • ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older

IMPORTANT SAFETY INFORMATION

Boxed WARNING: CAPILLARY LEAK SYNDROME

  • Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

  • Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.
  • Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.

Hypersensitivity Reactions

  • ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur.

Hepatotoxicity

  • Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption.
  • Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.

ADVERSE REACTIONS:

Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.

Please see full Prescribing Information, including Boxed WARNING.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION

INDICATION

  • ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older

IMPORTANT SAFETY INFORMATION

Boxed WARNING: CAPILLARY LEAK SYNDROME

  • Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

  • Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.
  • Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.

Hypersensitivity Reactions

  • ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur.

Hepatotoxicity

  • Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption.
  • Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.

ADVERSE REACTIONS:

Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.

Please see full Prescribing Information, including Boxed WARNING.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.