ELZONRIS is the first and only approved treatment for BPDCN, a deadly hematologic cancer.2,3 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.1,4
Efficacy in treatment-naive patients1*
CR/CRc rate†
ORR
bridged to stem cell transplantation
- The median duration of CR/CRc was not reached at the time of analysis; median follow-up was 19 months (range, 1-42 months)1
- The median time to CR/CRc was 43 days (range, 14-131 days)1
Efficacy in the pivotal cohort2,4
CR/CRc rate†
ORR
bridged to stem cell transplantation
- The median duration of CR/CRc has not yet been reached (range, 3.9-12.2 months)2
- The median time to CR/CRc was 57 days (range, 14-107 days)2
Efficacy in other cohorts4
- Efficacy measures included 88% CR/CRc rate,† 100% ORR, and 44% bridged to stem cell transplantation4
- The median duration of CR/CRc was not reached (range, 1.3-32.2 months)4
*Total population includes patients from the pivotal cohort.1
†CRc, clinical complete response; defined as complete response with residual skin abnormality not indicative of active disease.2
BPDCN, blastic plasmacytoid dendritic cell neoplasm; CR, complete response; ORR, overall response rate.
Explore the baseline characteristics of treatment-naive patients in the study
Key baseline demographics in the study reflect the patient population and variable presentation of BPDCN.2,4
Baseline characteristics of treatment-naive patients2,4
Characteristics | Pivotal cohort (n=13) |
Other cohorts (n=16) |
All cohorts (n=29) |
---|---|---|---|
Male, % (n) | 84.6% (11) | 75.0% (12) | 79.3% (23) |
Female, % (n) | 15.4% (2) | 25.0% (4) | 20.7% (6) |
Median age | (min, max)65.0 (22, 84) | 67.5 (28, 84) | 67.0 (22, 84) |
ECOG PS, % (n) | |||
0 | 61.5% (8) | 43.8% (7) | 51.7% (15) |
1 | 38.5% (5) | 56.3% (9) | 48.3% (14) |
BPDCN, % (n) | |||
Skin | 100.0% (13) | 93.8% (15) | 96.6% (28) |
Bone marrow | 53.8% (7) | 43.8% (7) | 48.3% (14) |
Peripheral blood | 23.1% (3) | 25.0% (4) | 24.1% (7) |
Lymph nodes | 46.2% (6) | 43.8% (7) | 44.8% (13) |
Viscera | 15.4% (2) | 12.5% (2) | 13.8% (4) |
ECOG PS, Eastern Cooperative Oncology Group performance status.
- References:
- Pemmaraju N, et al. Tagraxofusp in blastic plasmacytoid dendritic-cell neoplasm. N Engl J Med. 2019;380(17):1628-1637.
- ELZONRIS [prescribing information]. New York, NY: Stemline Therapeutics, Inc.; November 2022.
- Pagano L, et al. Blastic plasmacytoid dendritic cell neoplasm: diagnostic criteria and therapeutical approaches. Br J Haematol. 2016;174(2):188-202.
- Data on file. Stemline Therapeutics, Inc.