Astellas Announces Gilteritinib Met Primary Endpoint of Overall Survival in Phase III COMMODORE Trial for FLT3-Mutated Relapsed/Refractory AML

Astellas Pharma Inc. (TSE: 4503; President and CEO: Dr. Kenji Yasukawa, “Astellas”) announced today that a Phase 3 confirmatory clinical trial evaluating XOSPATA® (generic name: gilteritinib fumarate tablets; hereinafter collectively referred to as gilteritinib) for the treatment of adult patients with relapsed (disease recurrence) or refractory (treatment-resistant) acute myeloid leukemia (AML) harboring FLT3 mutations (FLT3mut+) met its primary endpoint of overall survival (OS) in a prespecified interim analysis, compared with salvage chemotherapy.

The COMMODORE trial is a multicenter, open-label, randomized controlled study conducted in China and other countries to compare the efficacy of gilteritinib versus salvage chemotherapy in adult patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML). Astellas has halted enrollment in this trial and will offer patients in the chemotherapy arm the opportunity to receive gilteritinib treatment.

Earlier this year, the China National Medical Products Administration (NMPA) granted conditional approval for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FMS-like tyrosine kinase 3 (FLT3) mutations, as detected by fully validated testing methods. Gilteritinib was granted priority review status by the NMPA in July 2020, included in the third batch of the List of Overseas New Drugs Urgently Needed for Clinical Use in November 2020, and approved through an accelerated pathway.

Astellas plans to submit the results of the COMMODORE trial to the National Medical Products Administration of China for regular marketing approval. Detailed results will also be submitted to peer-reviewed journals and/or scientific conferences.

Acute myeloid leukemia is a malignancy affecting the blood and bone marrow, with its incidence increasing with age. It is one of the most common leukemias in adults. It is estimated that over 85,000 people are diagnosed with leukemia annually in China.

In earlier trials, the safety of gilteritinib was evaluated in 319 patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations who received at least one dose of gilteritinib 120 mg/day. The most common adverse reactions of all grades (incidence ≥ 10%) associated with gilteritinib were increased alanine aminotransferase (ALT) (25.4%), increased aspartate aminotransferase (AST) (24.5%), anemia (20.1%), thrombocytopenia (13.5%), febrile neutropenia (12.5%), decreased platelet count (12.2%), diarrhea (12.2%), nausea (11.3%), increased blood alkaline phosphatase (11%), fatigue (10.3%), decreased white blood cell count (10%), and increased blood creatine phosphokinase (10%). One fatal adverse reaction of differentiation syndrome occurred in patients treated with gilteritinib. The most common serious adverse reactions (incidence ≥ 3%) were febrile neutropenia (7.5%), increased ALT (3.4%), and increased AST (3.1%). Other clinically significant serious adverse reactions included QT interval prolongation on electrocardiogram (0.9%) and posterior reversible encephalopathy syndrome (0.3%).

Note: The original text has been abridged.