TIBSOVO® was studied in patients with difficult-to-treat AML1
Selected baseline demographic and disease characteristics (N=28)1 | |
---|---|
Median age (years) (min, max) | 77 (64, 87) |
ECOG PS | |
0 | 21% |
1 | 57% |
2 | 18% |
3 | 4% |
ELN risk category | |
Intermediate | 32% |
Adverse | 68% |
Transfusion dependent at baselinea | 61% |
Type of AML | |
De novo AML | 21% |
AML-MRC | 68% |
Therapy-related AML | 11% |
Prior HMA for antecedent hematological disorder | 46% |
aPatients were defined as transfusion dependent at baseline if they received any RBC or platelet transfusion occurring within 56 days prior to the first dose of TIBSOVO.1 |
- Comorbidities that precluded the use of intensive induction chemotherapy included: baseline ECOG PS ≥2, severe cardiac or pulmonary disease, hepatic impairment with bilirubin >1.5 times the upper limit of normal, or creatinine clearance <45 mL/min1

-
11%
Patients who had therapy-related AML1 -
68%
Patients who had AML-MRC1
50% of patients had a history of MDS2
46% of patients had prior HMA therapy for an antecedent hematologic disorder1
TIBSOVO delivered strong and durable responses as an oral, single agent in difficult-to-treat disease1,2

-
28.6% (8/28) achieved CR (95% CI, 13.2-48.7);
14.3% (4/28) achieved CRh (95% CI, 4.0-32.7)1
Median duration of response1,b | |
---|---|
DOCR | DOCR+CRh |
NE (95% CI, 4.2-NE) | NE (95% CI, 4.2-NE) |
bDOCR and DOCR+CRh were defined as time since first response of CR or CR/CRh, respectively, to relapse or death, whichever is earlier.1 |
Median DOCR and median DOCR+CRh were not estimable (NE), with 5 patients (41.7%) who achieved CR or CRh remaining on TIBSOVO treatment (treatment duration range: 20.3-40.9 months).1
Time to response in patients who achieved CR or CRh1,2
Transfusion independence was seen in 41% of transfusion-dependent patients who received TIBSOVO1

- 55% of patients who were transfusion independent at baseline (6/11) remained so1
- Patients were defined as transfusion dependent at baseline if they received any RBC or platelet transfusion occurring within 56 days prior to the first dose of TIBSOVO. Patients were defined as transfusion independent if they became independent of transfusions during any 56-day postbaseline period1