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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

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

Sub-category:
Myeloproliferative Syndromes (MPD)

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

Meeting:
2019 ASCO Annual Meeting

Abstract No:
7057

Poster Board Number:
Poster Session (Board #432)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 7057)

Author(s): Claire N. Harrison, Nicolaas Schaap, Alessandro M Vannucchi, Jean-Jacques Kiladjian, Eric Jourdan, Richard T. Silver, Harry C. Schouten, Francesco Passamonti, Sonja Zweegman, Moshe Talpaz, Srdan Verstovsek, Torsten Gerike, Shelonitda Rose, Mingyu Li, Carrie Brownstein, Ruben A. Mesa; Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom; Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands; AOU Careggi, University of Florence, Florence, Italy; Hôpital Saint-Louis and Université Paris Diderot, Paris, France; Hématologie Clinique, Institut de Cancérologie du Gard, Nîmes Cedex 9, France; Weill Cornell Medical Center, New York, NY; University Hospital Maastricht, Maastricht, Netherlands; University of Insubria, Varese, VA, Italy; Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; Celgene Corporation, Summit, NJ; UT Health San Antonio Cancer Center, San Antonio, TX

Abstract Disclosures

Abstract:

Background: MF is a life-threatening MPN for which RUX is the only approved treatment (Tx) option. Patients (pts) who are relapsed/refractory (R/R) or intolerant to RUX have a particularly high unmet medical need. FEDR is an oral selective JAK2 inhibitor active against wt and mutJAK2. The JAKARTA-2 study demonstrated ≥35% spleen volume responses (SVR) in pts resistant or intolerant to RUX per investigator assessment. This JAKARTA-2 reanalysis employs a more stringent definition of RUX failure than used in the previous analysis. Methods: Adult pts previously treated with RUX with intermediate or high-risk primary, post-PV, or post-ET MF, palpable splenomegaly, ECOG PS ≤2, and platelet counts ≥50 × 109/L received FEDR 400 mg QD in continuous 28-day cycles. The primary endpoint was spleen volume response rate (SVRR): ≥35% SVR from baseline (BL) at cycle 6 end per blinded central review of MRI/CT scans. A key secondary endpoint was symptom RR (≥50% decrease in total symptom score from BL). Results: 79/97 enrolled pts (81%) met the more stringent criteria for RUX R/R (n=65, 82%) or intolerance (n=14, 18%). Median BL spleen volume was 2946 mL (~14× normal). Median prior RUX Tx duration was 11.5 mo (range 1.0–62.4). Median number of FEDR Tx cycles was 7 (1–20). SVRR with FEDR was 30% (95% CI 21, 42). KM estimated median spleen response duration was not estimable (95% CI 7.2 mo, NE). Symptom RR was 27%. Safety was consistent with prior reports. Conclusions: FEDR provided clinically meaningful reductions in splenomegaly and symptom burden in pts with MF who met more stringent criteria for R/R or intolerance to RUX. Clinical trial information: NCT01523171

RUX failure.

Prior AnalysisCurrent Analysis
ResistanceRUX Tx ≥ 14 d with no response or stable disease per investigator, disease progression, or loss of responseRelapsed: RUX Tx ≥ 3 mo with regrowth, defined as < 10% SVR or < 30% decrease in spleen size from BL, following an initial response
Refractory: RUX Tx ≥ 3 mo with < 10% SVR or < 30% decrease in spleen size from BL
IntoleranceRUX Tx ≥ 14 d before discontinuing Tx due to unacceptable toxicityRUX Tx ≥ 28 d complicated by development of RBC transfusion requirement (≥ 2 units/mo for 2 mo); or grade ≥ 3 thrombocytopenia, anemia, hematoma/hemorrhage while on RUX

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

Meeting: 2019 ASCO Annual Meeting Abstract No: 7058 First Author: Naveen Pemmaraju
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Myeloproliferative Syndromes (MPD)

 

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