BY: Kerri Fitzgerald
A phase 3 study is underway and enrolling patients to assess quizartinib plus chemotherapy in the induction, consolidation, and maintenance phases of treatment for FLT3-internal tandem duplication (ITD)-negative acute myeloid leukemia (AML).
Esther Natalie Oliva, MD, of London North West Healthcare NHS Trust, outlined the study at the European Society for Blood and Marrow Transplantation 51st Annual Meeting in Florence, Italy.
The phase 2 PETHEMA-QUIWI study of quizartinib plus chemotherapy showed significantly improved overall survival (OS) and served as the backbone for this new phase 3 study. The phase 2 study included 273 patients aged 18 to 70 years with newly diagnosed FLT3-ITD-negative AML who received quizartinib 60 mg/day with induction and consolidation chemotherapy followed by up to 12 months of quizartinib monotherapy for maintenance in patients achieving a complete remission (CR) or CR with incomplete count recovery (CRi).
The global phase 3, double-blind, randomized, placebo-controlled QuANTUM-Wild study will include patients aged 18 to years with newly diagnosed FLT3-ITD-negative AML who will be randomized 2:2:1 to receive:
- Quizartinib plus with chemotherapy for induction and consolidation followed by quizartinib monotherapy maintenance
- Placebo plus chemotherapy in all 3 treatment phases
- Quizartinib plus chemotherapy for induction and consolidation followed by placebo maintenance
Quizartinib will be administered at 60 mg/day. Induction therapy includes a 7+3 regimen of cytarabine on days one to seven and anthracycline on days one to three, followed by quizartinib or placebo from days 8 to 21. Patients who achieve CR/CRi will receive consolidation with high-dose cytarabine plus quizartinib or placebo for one to four cycles. Allogeneic hematopoietic cell transplant is an option per investigator’s decision. Patients can then receive their respective maintenance therapy for 28-day cycles for up to 36 cycles.
The primary endpoint is OS, with secondary endpoints including event-free survival, relapse-free survival, measurable residual disease negativity, safety, and more.
The researchers plan to enroll 700 patients from 170 sites through 2028. For more information, visit https://clinicaltrials.gov/study/NCT06578247.
Reference
Oliva EN, et al. QuANTUM-Wild: phase 3, randomized, double-blind quizartinib study in newly diagnosed, FLT3-ITD-negative acute myeloid leukemia. Abstract P290. Presented at the EBMT 51st Annual Meeting; March 30-April 2; Florence, Italy.
