New Data on Gilteritinib in AML Presented at 2020 American Society of Hematology Annual Meeting

Five oral presentations will include data on the use of gilteritinib, either as monotherapy or in combination, across the spectrum of patients with acute myeloid leukemia with a positive FLT3 mutation.

Astellas Pharma Inc has announced several oral presentations and posters to be presented at the upcoming 2020 American Society of Hematology Annual Meeting about the use of gilteritinib in the treatment of acute myeloid leukemia (AML).

The 5 oral presentations will include data on the use of gilteritinib, either as monotherapy or in combination, across the spectrum of patients with AML with a positive FLT3 mutation (FLT3mut-positive). Gilteritinib is approved in the United States for the treatment of adult patients who have relapsed or refractory FLT3mut-positive AML.

“The research being presented at ASH will shed light on critical unmet needs and continuing progress against AML, which remains a hard-to-treat cancer in spite of continuing medical advances,” said Andrew Krivoshik, MD, PhD, senior vice president and oncology therapeutic area head at Astellas, in a press release. “Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation. We also look forward to discussing our Phase 3 LACEWING trial in progress, as well as findings from the STREAMLINE study related to real-world FLT3 testing rates in AML patients, both upon diagnosis and after relapse.”

The 5 oral presentations include the results of a phase 1 study of gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed AML; an update on a phase 3 study of gilteritinib plus azacytidine or azacytidine alone in newly diagnosed FLT3mut-positive AML patients ineligible for intensive induction chemotherapy; a comparison of gilteritinib and salvage chemotherapy in FLT3mut-positive AML on the number needed to treat for various clinical outcomes; a review of the efficacy and safety of venetoclax in combination with gilteritinib for relapsed or refractory FLT3mut-positive AML; and clinical outcomes in patients with relapsed or refractory AML treated with gilteritinib who received prior midostaurin or sorafenib.

In addition, 3 posters will be presented, including a review of a retrospective cohort study of relapsed or refractory FLT3mut-positive AML; clinical outcomes following treatment with either gilteritinib or quizartinib in patients with relapsed or refractory AML with FLT3 internal tandem duplication; and a review of pain and opioid use in patients with FLT3mut-positive relapsed or refractory AML.

An online-only presentation will also be presented regarding the use of FLT3-tyrosine kinase inhibitors in relapsed or refractory FLT3mut-positive AML.

REFERENCE

Astellas to Present New Data on Gilteritinib in FLT3 Mutation-Positive Acute Myeloid Leukemia at the 2020 American Society of Hematology Annual Meeting [news release]. Astellas; November 16, 2020. https://www.astellas.com/us/news/5276. Accessed December 3, 2020.