Astellas Pharma and BMT CTN announce phase 3 data for gilteritinib

James Spargo | June 9, 2023 | News story | Research and Development Astellas Pharma, BMT CTN, Haematology, gilteritinib, leukaemia, pharmaceutical 

Japanese pharmaceutical company Astellas Pharma and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) have presented their phase 3 data from the MORPHO clinical trial which reviewed gilteritinib for the treatment of FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukaemia (AML) patients, including a subgroup with detectable measurable residual disease (MRD).

Gilteritinib is an FLT3 inhibitor that was evaluated as a maintenance therapy following allogeneic haematopoietic stem cell transplantation (HSCT) in 356 patients diagnosed with AML plus the FLT3-ITD mutation in the MORPHO two-arm, randomised, double-blind, placebo-controlled, multi-centre phase 3 trial. Patients were required to be in complete remission before the transplant, after which they were randomised to receive 120mg of gilteritinib or placebo for a two-year period.

The trial did not demonstrate statistically significant improvement of relapse-free survival (RFS) in the entire cohort. However, there was clinical improvement of RFS in a subgroup of patients with detectable MRD compared to those without. In exploratory analysis, gilteritinib showed favourable RFS for around 50% of patients with detectable MRD pre- or post-HSCT, compared to those without.

Ahsan Arozullah MD MPH, senior VP and head of Oncology Development at Astellas, stated: “While we are continuing to conduct a thorough assessment of the full data set from our phase 3 MORPHO trial, we are encouraged by this data which explores the potential of gilteritinib in a maintenance setting. AML patients with a FLT3-ITD mutation often face worse outcomes than those with other mutations and have restricted post-HSCT treatment options with unmet need. With these findings, we remain focused on sharing updates with the scientific community to inform continued innovation for the AML community.”

Mary M Horowitz MD, principal investigator of the BMT CTN Data and Coordinating Center, commented: “As the AML treatment landscape continues to evolve, the exploration of prognostic indicators like MRD, which may be used to guide the management of AML, is vital to advance science and patient care. We look forward to continuing our collaboration with Astellas to explore innovative approaches for those impacted by AML.”

James Spargo

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