Xospata keeps failing in the first line

After years of trying to push its FLT3 inhibitor Xospata into earlier lines of treatment for acute myeloid leukaemia, Astellas has notched another setback. The company said the investigator-initiated phase 3 Pasha trial, testing Xospata against Rydapt in newly diagnosed FLT3-mutated AML patients eligible for intensive chemotherapy, failed to meet its primary endpoint of overall survival at the primary analysis. The study was placed on clinical hold in 2022 following a recommendation from the DSMB, before being restarted four months later, without Astellas providing further details about the reasons for the pause. The miss marks the third phase 3 failure in six years tied to Astellas's efforts to move Xospata beyond its current relapsed or refractory AML niche into earlier treatment settings. The first was the Lacewing trial, which evaluated Xospata alongside Vidaza in patients with FLT3-mutated AML who were not eligible for intensive chemotherapy. Next was the Morpho trial, which tested Xospata as a maintenance therapy following cell transplantation. Despite the string of clinical setbacks, development work continues. Last month, the European Organisation for Research and Treatment of Cancer began a trial evaluating the triplet of Xospata, Vidaza and Venclexta against chemo in first-line patients eligible for intensive chemo. 

Selected phase 3 trials of Xospata in early AML settings

Note: *investigator-initiated trial. Source OncologyPipeline.