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Attend this session at the
2019 ASCO Annual Meeting!


Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A

Results from ongoing phase 1/2 clinical trial of tagraxofusp (SL-401) in patients with intermediate or high risk relapsed/refractory myelofibrosis.

Sub-category:
Myeloproliferative Syndromes (MPD)

Category:
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Meeting:
2019 ASCO Annual Meeting

Abstract No:
7058

Poster Board Number:
Poster Session (Board #433)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 7058)

Author(s): Naveen Pemmaraju, Haris Ali, Vikas Gupta, Gary J. Schiller, Sangmin Lee, Abdulraheem Yacoub, Moshe Talpaz, Halyna Wysowskyj, Shay Shemesh, Janice Chen, Christopher Brooks, Enrique Poradosu, Nicole Rupprecht, Animesh Dev Pardanani, Ayalew Tefferi, Eunice S. Wang, Minakshi Taparia, Srdan Verstovsek, Joseph Khoury, Mrinal Mahesh Patnaik; Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX; City of Hope Medical Center, Duarte, CA; Princess Margaret Cancer Centre, Toronto, ON, Canada; University of California, Los Angeles, Los Angeles, CA; Columbia Univ, New York, NY; The University of Kansas Cancer Center, Westwood, KS; University of Michigan, Ann Arbor, MI; Stemline Therapeutics, New York, NY; Stemline Therapeutics, Inc, New York, NY; Mayo Clinic, Rochester, MN; Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY; University of Alberta Hospital, Edmonton, AB, Canada; The University of Texas MD Anderson Cancer Center, Houston, TX

Abstract Disclosures

Abstract:

Background: Patients with myelofibrosis (MF) who fail or are intolerant to JAK inhibitors (JAKi) have no standard treatment options. CD123 is expressed on a variety of malignancies, including MF. CD123+ plasmacytoid dendritic cells (pDCs), in the MPN microenvironment, including chronic myelomonocytic leukemia and MF, may be tumor-promoting. Monocytosis in MF associated with rapid disease progression and short survival, suggesting an accelerated disease phase. Notably, monocytes share a common precursor with CD123+ pDCs. Tagraxofusp, a novel CD123 targeted therapy, demonstrated high activity in patients with BPDCN, an aggressive hematologic malignancy derived from CD123+ pDCs, and is FDA approved in BPDCN. As such, tagraxofusp may offer a novel therapeutic approach in MF. Methods: Multicenter, 2-stage Ph 1/2 trial enrolling patients (pts) with MF relapsed, refractory, or intolerant to JAKi. Objectives: determine optimal dose, evaluate safety and efficacy. Stage 1 dose escalation: IV tagraxofusp (7, 9, and 12 mcg/kg/day) dosed daily days 1-3 every 21 days (C1-4), 28 days (C5-7), and 42 days (C8+). Stage 2 (ongoing): pts receive optimal S1 dose (12 mcg/kg/day; no MTD). Results: 23 r/r pts treated. Median age 69 (55-81); 57% female. DIPSS Plus: 4% INT-1, 55% INT-2, 41% high. Baseline platelets: median 59 K/uL (15-579); 70% (16/23) <100 K/uL, 8 pts <50 K/uL. 87% (20/23) baseline splenomegaly (palpable ≥5 cm below left costal margin by physical exam). Most common TRAEs: headache (22%), hypoalbuminaemia (22%), ALT incr. (17%) and thrombocytopenia (17%). Most common ≥Gr3 TRAE thrombocytopenia (2%). Capillary leak syndrome in 1 pt (4%; Gr3). 57% (8/14) of pts with baseline spleen ≥5cm BCM spleen responses: 43% (6/14) had ≥29% and 21% (3/14) had ≥45% reduction. 100% of pts with baseline spleen ≥5cm and monocytosis splenomegaly reductions: 80% (4/5) had ≥29% and 40% (2/5) had ≥45%. 6 pts (3 monocytosis pts and 5 pts platelets <100 K/uL) had 6 mos+ duration, 9 pts ongoing. Conclusions: Tagraxofusp demonstrated single agent activity (reduction in splenomegaly) and manageable safety in R/R MF, including pts with monocytosis, an unmet medical need. Given the presence of CD123+ pDCs, tagraxofusp may offer a novel targeted approach in MF. Updated data to be presented. Registrational designs are being evaluated. Clinical trial information: NCT02268253

 
Other Abstracts in this Sub-Category:

 

1. Proposal of an endpoint for a phase III clinical study of essential thrombocythemia: Balancing between short term effects and long term benefits.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7055 First Author: Ruben A. Mesa
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Myeloproliferative Syndromes (MPD)

 

2. A phase II study of cpi-0610, a bromodomain and extraterminal protein inhibitor (BETi) alone or with ruxolitinib (RUX), in patients with myelofibrosis (MF).

Meeting: 2019 ASCO Annual Meeting Abstract No: 7056 First Author: Marina Kremyanskaya
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Myeloproliferative Syndromes (MPD)

 

3. Fedratinib (FEDR) in myelofibrosis (MF) patients previously treated with ruxolitinib (RUX): A reanalysis of the JAKARTA-2 study.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7057 First Author: Claire N. Harrison
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Myeloproliferative Syndromes (MPD)

 

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