- Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned interim analysis -

TOKYO, March 30, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that a Phase 3 confirmatory trial of XOSPATA® (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to treatment) FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis. 

COMMODORE is an open-label, randomized study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in China and other countries. Astellas has stopped enrollment in the trial and patients in the chemotherapy arm will be offered the opportunity to receive gilteritinib.

Earlier this year, the China National Medical Products Administration (NMPA) granted conditional approval to gilteritinib for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation detected by a fully validated test. Approval was granted under an expedited pathway, following NMPA’s acceptance of gilteritinib for priority review in July 20201  and its inclusion in the third batch of overseas new drugs urgently needed in clinical settings in November 2020.2 

Astellas plans to submit results of COMMODORE to the NMPA in support of full approval.  Detailed results will also be submitted to a peer-reviewed journal and/or scientific congress. 

“In COMMODORE, patients receiving gilteritinib lived longer than those receiving salvage chemotherapy, confirming the overall survival benefit seen in the Phase 3 ADMIRAL trial,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development. “For these patients, who have limited treatment options, the new findings provide additional evidence supporting gilteritinib as a treatment option.” 

AML is a cancer that impacts the blood and bone marrow,3 and its incidence increases with age.4 It is one of the most common types of leukemia in adults.5 Every year, it is estimated that more than 85,000 people in China are diagnosed with leukemia.6 

In previous clinical trials, the safety of gilteritinib was evaluated in 319 patients with relapsed or refractory AML who had received at least one dose of 120 mg gilteritinib daily.7 The most frequent all-grade adverse reactions (frequency ≥ 10%) with gilteritinib were alanine aminotransferase (ALT) increased (25.4%), aspartate aminotransferase (AST) increased (24.5%), anemia (20.1%), thrombocytopenia (13.5%), febrile neutropenia (12.5%), platelet count decreased (12.2%), diarrhea (12.2%), nausea (11.3%), blood alkaline phosphatase increased (11%), fatigue (10.3%), white blood cell count decreased (10%), and blood creatine phosphokinase increased (10%). One fatal adverse reaction of differentiation syndrome occurred in patients receiving gilteritinib. The most frequent (frequency ≥3%) serious adverse reactions were febrile neutropenia (7.5%), ALT increased (3.4%), and AST increased (3.1%). Other clinically significant serious adverse reactions included electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.3%).


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