Table 2.
Key favorable and unfavorable effects for gilteritinib monotherapy for adult patients with relapsed or refractory acute myeloid leukemia with FLT3 mutation (study 2215‐CL‐0301, cutoff date: September 17, 2018)
| Effect | Treatment: gilteritinib (n = 247) | Control: chemotherapy (n = 124) | Uncertainties, strength of evidence |
|---|---|---|---|
| Favorable effects | |||
| OS (median time from randomization until death by any cause), months |
9.3 (7.7–10.7) |
5.6 (4.7–7.3) |
HR, 0.637 95% CI, 0.490–0.830 One‐sided p = .0004 |
| Unfavorable effects,a % | |||
| TEAE | |||
| All grades | 83.1 | 65.1 | N/A |
| Grade ≥3 | 60.2 | 52.3 | |
| ALT increased | |||
| All grades | 82.1 | 47.7 | |
| Grade ≥3 | 12.9 | 2.8 | |
| Diarrhea | |||
| All grades | 35.1 | 29.4 | |
| Grade ≥3 | 4.1 | 2.8 | |
| Nausea | |||
| All grades | 29.8 | 33 | |
| Grade ≥3 | 1.9 | 0 | |
| Fatigue | |||
| All grades | 30.4 | 12.8 | |
| Grade ≥3 | 3.1 | 0 | |
| QT prolongation | |||
| All grades | 8.8 | 0 | |
| Grade ≥3 | 2.5 | 0 | |
| Myalgia | |||
| All grades | 12.5 | 0 | |
| Grade ≥3 | 0.3 | 0 |
a
Integrated 120 mg gilteritinib population, n = 319; and chemotherapy, n = 109.
Abbreviations: ALT, alanine aminotransferase; CI, confidence interval; HR, hazard ratio; N/A, not applicable; OS, overall survival; TEAE, treatment‐emergent adverse event.