BUFFALO, N.Y., Dec. 5, 2020 /PRNewswire-PRWeb/
-- Eunice Wang, MD, Chief of
Leukemia and Director of Infusion Services at Roswell Park
Comprehensive Cancer Center, is leading multiple research efforts
focused on different treatment approaches for acute myeloid
leukemia (AML) patients. Today, during the 62nd American Society of
Hematology (ASH) Annual Meeting and Exposition, which is being held
virtually, she is presenting data on two ongoing studies
incorporating new treatment options.
KOMET-001 (NCT04067336) is an ongoing phase I/IIA open-label
study evaluating KO-539, a once-daily oral drug, in adult AML
patients at Roswell Park and select other sites in the U.S. and
Europe. KO-539 is a novel
experimental inhibitor of the menin-KMT2A complex, which is
dysregulated in acute leukemias characterized by rearrangements in
the MLL gene and mutations in the NPM1 gene.
The phase I dose-escalation aims to assess safety and
tolerability, characterize the pharmacokinetics, and determine a
recommended phase II dose. Researchers will examine anti-leukemic
activity, pharmacokinetics, safety and tolerability in patients
with select genetic subtypes of AML during the phase IIA dose
expansion.
"Preliminary results demonstrate that the drug appears to be
safe and well-tolerated in adult patients with relapsed/refractory
AML failing 3-7 prior lines of therapy," says Dr. Wang. "None of 12
patients treated to date have discontinued therapy due to toxicity.
Moreover, six of eight evaluable patients to date have shown some
evidence of anti-leukemic activity, with two individuals achieving
complete remissions on therapy. This promising trial continues to
enroll."
Dr. Wang will also present early findings from the randomized,
multicenter, open-label phase III LACEWING study exploring the
efficacy of gilteritinib, a FLT3 inhibitor, combined with low-dose
chemotherapy compared to low-dose chemotherapy alone. Eligible
patients include those with newly diagnosed FLT3 mutant AML who are
considered unfit for intensive chemotherapy.
The primary objective of this study was overall survival.
Secondary endpoints included event-free survival, best response,
remission rates and duration, transfusion conversion and
maintenance rates, leukemia-free survival, patient-reported
fatigue, and safety/tolerability.
Patients in an initial safety cohort received gilteritinib
(80-120 mg daily) plus the low-dose chemotherapy azacitidine.
Mature data presented today show that 10 of 15 patients (67%)
achieved a complete response or complete response, with incomplete
count recovery on therapy with a median overall survival of 10.4
months. The adverse events observed by researchers were hematologic
and no new safety signals have been associated with gilteritinib
(120 mg daily) when combined with azacitidine.
Enrollment in the randomized portion of the LACEWING trial is
ongoing, with 136 of 250 anticipated patients accrued to date.
Patients in this group will be randomized 2:1 to receive oral
gilteritinib in combination with azacitidine. Based on data from
the safety cohort, patients will receive a gilteritinib dose of 120
mg daily alongside low-dose chemotherapy.
"It's encouraging to see signals of efficacy and evidence of
good tolerability in these emerging treatment options, especially
for subgroups of patients with AML whose cancers have been
especially resistant to other therapies," notes Dr. Wang.
ASH 2020 Presentation Details:
Preliminary Data on a Phase 1/2A First in Human Study of the
Menin-KMT2A (MLL) Inhibitor KO-539 in Patients with Relapsed or
Refractory Acute Myeloid Leukemia
Abstract 115
Presenting author: Eunice Wang, MD,
Roswell Park Comprehensive Cancer Center
Time/date: Saturday, Dec. 5,
10:30 a.m. PST
Session: 616, Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Novel promising therapies for relapsed/refractory
AML
Phase 3, Multicenter, Open-Label Study of Gilteritinib,
Gilteritinib Plus Azacitidine, or Azacitidine Alone in Newly
Diagnosed FLT3 Mutated (FLT3mut+) Acute Myeloid Leukemia (AML)
Patients Ineligible for Intensive Induction Chemotherapy
Abstract 27
Presenting author: Eunice Wang, MD,
Roswell Park Comprehensive Cancer Center
Time/date: Saturday, December 5,
8:15 a.m. PST
Session: 616, Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Novel combination therapies in treatment of newly
diagnosed AML
For an online version of this release, please visit:
https://www.roswellpark.org/newsroom/202012-roswell-park-leukemia-chief-shares-promising-findings-new-treatment-options-ash
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its secrets through personalized approaches and unleashing the
healing power of hope. Founded by Dr. Roswell Park in 1898, it is
the only National Cancer Institute-designated comprehensive cancer
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http://www.roswellpark.org, or contact us at 1-800-ROSWELL
(1-800-767-9355) or ASKRoswell@RoswellPark.org.
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Roswell Park Comprehensive Cancer Center
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SOURCE Roswell Park Comprehensive Cancer Center