The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

The LACEWING trial ( Identifier: NCT02752035) continues to enroll patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML) to test the combination of gilteritinib — an oral FLT3 inhibitor — plus azacitidine compared with azacitidine alone, according to a presentation by Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

“Based on the positive results of the phase 3 ADMIRAL trial in October 2020, gilteritinib had been approved in 41 countries and regions for the treatment of adult patients with relapsed/refractory FLT3-mutated AML,” Dr Wang said.

The trial includes patients with newly diagnosed FLT3-mutated AML 65 years or older who have been deemed ineligible for intensive induction chemotherapy by the investigator, and patients aged 18 to 64 years with specific comorbidities causing ineligibility for intensive induction chemotherapy.

Continue Reading

The study included a safety cohort where 15 patients received gilteritinib 80 mg per day as an initial dose (or 120 mg per day at the next dose level) plus azacitidine 75 mg/m2.

In the safety cohort, 1 patient remains on treatment; 14 patients have died. The median treatment duration was 6 cycles. The complete remission rate was 33% and the composite complete remission rate was 67%.

Among the 10 patients with composite complete remission, the median duration of remission was 10.4 months. All 15 patients had at least 1 treatment-emergent adverse event, with 40% experiencing an event that led to treatment withdrawal. None of the events were judged to be related to gilteritinib.

Based on the results of the safety phase, the recommended phase 2 dose was 120 mg per day gilteritinib plus azacitidine.

The randomization cohort is planned to include 250 patients who will be randomly assigned in a 2:1 ratio to receive 120 mg oral gilteritinib on days 1 through 28 plus azacitidine on days 1 through 7 (Arm AC) or azacitidine alone (Arm A). The primary endpoint is overall survival. At the time of the ASH presentation, 136 patients had been randomly assigned to receive treatment.

At data analysis, 61% of the patients in the randomization cohort had died. The median treatment duration was 4 cycles.

“As the study progresses, patients with newly diagnosed FLT3-mutated AML considered to be unfit for intensive chemotherapy will continue to be randomized 2:1 to receive gilteritinib 120 mg/day plus azacitidine or azacitidine monotherapy for upfront therapy,” Dr Wang said.

Disclosure: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.

Read more of Cancer Therapy Advisor‘s coverage of the ASH 2020 meeting by visiting the conference page.


Wang ES, Montesinos P, Minden MD, et al. Phase 3, multicenter, open-label study of gilteritinib, gliteritinib plus azacitidine, or azacitidine alone in newly diagnosed FLT3 mutated (FLTmut+) acute myeloid leukemia (AML) patients ineligible for intensive induction chemotherapy. Presented at: the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020. Abstract 27.