Table 2:
Response rates (95% confidence intervals) and median (range) duration of response in months.
| Interim analysisa | Final analysis | ||
|---|---|---|---|
| Group | Gilteritinib (N=138) | Gilteritinib (N=247) | Chemotherapy (124) |
| CR/CRh | 29 (21%) (15%, 29%) |
57 (23%) (18%, 29%) |
N/Ab |
| DOCR+CRh | 4.6 (0.1, 15.8+) |
7.4 (<0.1+, 23.1+) |
N/Ab |
| CR | 16 (12%) (7%, 18%) |
35 (14%) (10%, 19%) |
13 (11%) (6%, 17%) |
| DOCR | 8.6 (1.0, 13.8) |
14.8 (0.6, 23.1+) |
1.8 (<0.1+, 1.8) |
| CRh | 13 (9%) (5%, 16%) |
22 (9%) (6%, 13%) |
N/Ab |
| DOCRh | 2.9 (0.1, 15.8+) |
2.9 (<0.1+, 9.5+) |
N/Ab |
CR, complete remission; CRh, complete remission with incomplete hematologic recovery; DOCR+CRh, duration of CR plus CRh responses; DOCR, duration of CR; DOCRh, duration of CRh; NA, not applicable; NE=not estimable
a
This analysis was used for the approval. The chemotherapy arm was not assessed in the interim analysis
b
CRh was not assessed by FDA on the chemotherapy arm given that CRh is not considered an appropriate efficacy endpoint for regimens causing drug-induced cytopenias.