ADMIRAL TRIAL

Help Patients Achieve Remission With XOSPATA1,2

Higher rate of CR* with XOSPATA vs salvage chemotherapy1†


14.2%

CR with XOSPATA (95% CI: 10.1, 19.2; n=35/247)
vs 10.5% CR with salvage chemotherapy
(95% CI: 5.7, 17.3; n=13/124)

*CR was defined as normal marrow differential with <5% blasts, ANC ≥1.0 x 109/L and platelets ≥100 x 109/L, no evidence of extramedullary leukemia, and must have been RBC and platelet transfusion independent.1

Only responses prior to HSCT were included in the response rate.1

MEDIAN DURATION OF COMPLETE REMISSION1†‡


14.8 months duration of complete remission (DOR) with XOSPATA. 1.8 months median DOR with salvage chemotherapy.
14.8 months duration of complete remission (DOR) with XOSPATA. 1.8 months median DOR with salvage chemotherapy.

Only responses prior to HSCT were included in the response rate.1

DOR was defined as the time from the date of first remission until the date of a documented relapse.1

22.6% CR/CRh rate|| with XOSPATA (n=55/243)

7.4 months Median DOR with XOSPATA

Median DOR with XOSPATA
(range: <0.1+ to 23.1+ months)

2 months median time to first response
(range: 0.9 to 9.6 months)

  • In patients who achieved CR/CRh with XOSPATA

§CRh was defined as marrow blasts <5%, partial hematologic recovery, ANC ≥0.5 x109/L and platelets ≥50 x 109/L, no evidence of extramedullary leukemia, and could not have been classified as CR.1

||CR/CRh rate was defined as the number of patients who achieved either CR or CRh at any post-baseline visit divided by the number of patients in the analysis population.2

The following rate and duration of CRc results from the ADMIRAL trial are not contained in the approved product labeling for XOSPATA and were not powered for statistical significance. Therefore, these results should be interpreted with caution and should not be used to make comparisons between treatment arms. CRc is a composite endpoint including CR, CRp, or CRi.2 The use of CRi and CRp to demonstrate meaningful treatment benefits in AML clinical trials has not been established.

54.3%

CRc with XOSPATA (95% CI: 47.8, 60.6; n=134/247)2

21.8%

CRc with chemotherapy (95% CI: 14.9, 30.1; n=27/124)2

  • The median duration of CRc was 4.6 months with XOSPATA (95% CI: 3.7, 7.7) and was not estimable with salvage chemotherapy (95% CI: 1.8, NE)2
  • The rate of CRc was defined as the number of patients who achieved the best response of CRc (CR, CRp, or CRi) divided by the number of patients in the analysis population2
  • The majority of patients who received salvage chemotherapy finished the study by Cycle 2 of treatment, resulting in a short duration of exposure, limited follow-up response, and high censoring of the duration of CRc2

Among patients in the XOSPATA arm who were transfusion dependent at baseline (n=197),

34.5% became transfusion independent during any 56-day post-baseline period (n=68/197)
  • Of the 49 patients in the XOSPATA arm who were transfusion independent at baseline, 59.2% remained transfusion independent during any 56-day post-baseline period (n=29/49)1

Transfusion independence was defined as patients who were dependent on RBC and/or platelet transfusions at baseline and became independent of RBC and platelet transfusions during any 56-day post-baseline period.1

ANC=absolute neutrophil count; CI=confidence interval; CR=complete remission; CRc=composite complete remission; CRh=complete remission with partial hematologic recovery; CRi=complete remission with incomplete hematologic recovery; CRp=complete remission with incomplete platelet recovery; DOR=duration of remission; HSCT=hematopoietic stem cell transplant; NE=not estimable; RBC=red blood cell.

References: 1. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Astellas. XOSPATA. Data on File. 3. ClinicalTrials.gov. A study of ASP2215 versus salvage chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) with FMS-like tyrosine kinase (FLT3) mutation (09-15-2020). https://clinicaltrials.gov/ct2/show/NCT02421939. Accessed 09-30-2020.