• Phase 2 trial enrolled 44 patients with FLT3-mutant acute myeloid leukemia
  • Combination of crenolanib and standard chemotherapy was safe and effective
  • This combination could become new standard of care; phase 3 trial enrolling

Newswise — CHICAGO, Ill. — On Tuesday, June 7, Eunice Wang, MD, Chief of Leukemia at Roswell Park Comprehensive Cancer Center, will present the long-term results of a phase 2 clinical trial combining crenolanib, a second-generation FLT3 inhibitor, with standard intensive chemotherapy for treatment of adults with newly diagnosed FLT3-mutant acute myeloid leukemia (AML). Dr. Wang will discuss the findings at the American Society of Clinical Oncology (ASCO) annual meeting 2022, at 11:57 a.m. CDT, in Hall S, room 100a, during the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant oral abstract session (abstract 7007). 

In this multicenter Roswell Park-led clinical trial, 44 patients with newly diagnosed FLT3-mutant AML received standard front-line induction chemotherapy with cytarabine for 7 days and daunorubicin or idarubicin for 3 days. Starting on day 9, crenolanib, which is an active inhibitor of FLT3- ITD, TKD and variant AML mutations, was administered three times per day until 3 days before the next chemotherapy treatment. Most patients (75%) had FLT3-ITD mutations, 8 patients (18%) had TKD mutations, and 3 patients (7%) had both ITD and TKD mutations.

After one treatment cycle, 73% of patients experienced clinical responses, and 86% of patients responded to treatment after two cycles. Better responses were noted in younger patients (≤ 60 years) and those with FLT3-ITD mutations.

“Our results were highly promising, with more than 80% of patients who received the crenolanib chemotherapy combination achieving clinical responses after treatment, and more than half still alive after almost 4 years,” says Dr. Wang, principal investigator of the clinical trial and senior author of the study. “We believe that addition of this next-generation FLT3 inhibitor to conventional chemotherapy could significantly improve outcomes and become the new standard of care for patients with FLT3-mutant AML.”

The most common treatment-related adverse events were diarrhea, nausea and febrile neutropenia, and six patients required crenolanib dose reduction during treatment. Approximately 15% of patients experienced disease relapse, but mutational analysis in these patients showed clearance of multiple FLT3 mutations and no new FLT3 clones.

A larger, phase 3 clinical trial (NCT03258931) randomizing patients with newly diagnosed FLT3-mutant AML to receive either crenolanib or midostaurin is underway at 31 sites and currently enrolling patients at Roswell Park.


This release is also available at: https://www.roswellpark.org/newsroom/202206-roswell-park-expert-present-effectiveness-new-combination-acute-myeloid-leukemia

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking 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 center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or [email protected].

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ASCO 2022