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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

Phase 3 PhALLCON study: Ponatinib (PON) versus imatinib (IM) with reduced-intensity chemotherapy (CT) in patients (pts) with newly diagnosed Philadelphia chromosome–positive (Ph+) ALL.

Sub-category:
Acute Leukemia

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

Meeting:
2019 ASCO Annual Meeting

Abstract No:
TPS7061

Poster Board Number:
Poster Session (Board #436a)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr TPS7061)

Author(s): Elias Jabbour, Giovanni Martinelli, Marco Vignetti, Josep-Maria Ribera, David Gomez-Almaguer, Yosuke Minami, Jing Xu, Shouryadeep Srivastava, Frank Neumann, Hagop M. Kantarjian; The University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy; GIMEMA Research Foundation, Rome, Italy; Hospital Universitari Germans Trias i Pujol, Barcelona, Spain; Hospital Universitario, Nuevo León, Mexico; Department of Transfusion Medicine and Cell Therapy, Kobe University Hospital, Kobe, Japan; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA; University of Texas MD Anderson Cancer Center, Houston, TX

Abstract Disclosures

Abstract:

Background: Therapies for adults with newly diagnosed Ph+ ALL are limited and associated with poor outcomes. PON, a potent TKI, is active against native BCR-ABL1 and all identified single resistance mutations, including T315I, which confers resistance to other TKIs (Zhou. Chem Biol Drug Des 2011;77). In the phase 2 PACE study, PON had a 41% major hematologic response rate in heavily pretreated Ph+ ALL, but responses were not durable mainly due to compound mutations (Cortes. Blood 2018;132; Pritchard. Blood 2016;128). As PON suppresses single BCR-ABL1 resistance mutations, resistance in Ph+ ALL is acquired through compound mutations. Decreased likelihood of compound mutations with first-line PON in Ph+ ALL may lead to more durable responses compared with PON in later lines of therapy. In a phase 2 study of PON with CT in newly diagnosed Ph+ ALL, long-term outcomes were improved vs first/second-generation TKIs (Jabbour. Lancet Haematol 2018;5). The PhALLCON trial compares first-line PON vs IM with reduced-intensity CT. Methods: This open-label trial (NCT03589326) is enrolling 230–320 pts (≥18 y) with newly diagnosed Ph+ or BCR-ABL1–positive ALL (p190/p210) and ECOG status ≤2. Pts are randomized 2:1 to PON 30 mg/d or IM 600 mg/d PO with reduced-intensity CT in induction (cycles [C] 1-3), consolidation (C4-9), and maintenance (C10-20). PON dose is reduced to 15 mg once pt achieves minimal residual disease–negative (MRD−) complete remission (CR). After 20C, pts stay on single-agent PON/IM. CNS prophylaxis: 2x/mo in C1-6. Primary endpoint: MRD− (BCR-ABL/ABL1 ≤0.01%) CR (end of induction). Key secondary endpoint: EFS; others in the Table. Subgroup analysis: pts with/without HSCT. Exploratory endpoints include mutation status. Initiated Aug 2018; to include ~110 sites in ≤35 countries. Currently, 5 active sites (4 US, 1 Spain); accrual ongoing. Clinical trial information: NCT03589326

Secondary Endpoints

• CR/incomplete blood count recovery rates

• Molecular response rates (MR3, MR4, MR4.5)

• MRD− CR rates/duration

• Primary induction failure

• ORR

• CR duration

• Time to treatment failure

• 5 duration

• OS

• Safety, including arterial occlusive/venous thrombotic/embolic events

 
Other Abstracts in this Sub-Category:

 

1. Effect of gilteritinib on survival in patients with FLT3-mutated (FLT3mut+) relapsed/refractory (R/R) AML who have common AML co-mutations or a high FLT3-ITD allelic ratio.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7000 First Author: Mark J. Levis
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Acute Leukemia

 

2. A randomized phase II trial of CX-01 with standard therapy in elderly patients with acute myeloid leukemia (AML).

Meeting: 2019 ASCO Annual Meeting Abstract No: 7001 First Author: Tibor Kovacsovics
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Acute Leukemia

 

3. Association of smoking with poor risk ELN 2017, cytogenetics/molecular profile, and survival outcomes in acute myeloid leukemia.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7002 First Author: Mansour Alfayez
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Acute Leukemia

 

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