TIBSOVO® (ivosidenib tablets) 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% |
ECOG PS, Eastern Cooperative Oncology Group Performance Status; ELN, European LeukemiaNet; HMA, hypomethylating agent; MDS, myelodysplastic syndrome; MRC, myelodysplasia-related changes.
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
Many patients in the clinical trials had poor performance status and were not good candidates for myelosuppressive regimens1,2

79% of patients (22/28) had secondary AML1
46% of patients had prior HMA therapy for an antecedent hematologic disorder1
50% of patients had a history of MDS2
TIBSOVO delivered strong responses as a once-daily oral treatment in a difficult-to-treat disease1,2

43% of patients (12/28) achieved CR or CRh (95% CI, 24.5‑62.8)1
TIBSOVO provided durable responses1
Median duration of response (months)1,b | |
---|---|
DOCR | DOCR+CRh |
NE (95% CI, 4.2-NE) | NE (95% CI, 4.2-NE) |
b DOCR and DOCR+CRh were defined as time since first response of CR or CR/CRh, respectively, to relapse or death, whichever was earlier.1 |
Median DOCR and median DOCR+CRh were not estimable (NE), with 5 patients who achieved CR or CRh (42%) remaining on TIBSOVO treatment (treatment duration range, 20.3-40.9 months).1
- 58% of those who achieved CR or CRh (7/12) were in remission at 12 months after initiating treatment2
CR, complete remission, defined as <5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets >100,000/microliter and absolute neutrophil counts >1000/microliter); CRh, complete remission with partial hematological recovery, defined as <5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and absolute neutrophil counts >500/microliter).1
TIBSOVO enabled strong and rapid responses1,2
Time to response in patients who achieved CR or CRh


TIME (MONTHS)
Median time to first response: 1.9 months (range, 0.9‑3.6)2
Median time to CR or CRh: 2.8 months (range, 1.9‑12.9)1
Earliest CR or CRh achieved: 1.9 months1
~1 month
Decrease in bone marrow blasts and increase in neutrophil counts3
Earliest time to first response: 0.9 months2
- 92% of patients taking TIBSOVO who achieved CR or CRh (11/12) reached this milestone within 6 months1
- The latest CR was achieved at 4.6 months2
- For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response2
Transfusion independence was seen in 41% of transfusion-dependent patients who received TIBSOVO1

41% of patients who were transfusion dependent at baseline (7/17) became transfusion independent1
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 period.1
RBC, red blood cell.
TIBSOVO enabled improvements in key hematologic parameters3
Mean bone marrow aspirate blasts decreased coincident with increased platelet, neutrophil, and hemoglobin valuesc








Adapted with permission from Roboz GJ et al. Blood. 2020;135(7):463-471.3
c Data are mean values with standard deviations.
d One patient enrolled in the dose-escalation phase was positive for the IDH1-D54N mutation by local testing and was not positive for the IDH1-R132 mutation by the companion diagnostic test; this patient was therefore excluded from the efficacy analyses.
TIBSOVO delivered strong and durable responses as a once-daily oral treatment in the secondary AML setting2

41% of patients with sAML (9/22) achieved CR or CRh2
- 56% of patients with sAML who achieved CR or CRh (5/9) were in remission at 12 months after initiating treatment2

31% of patients with prior HMA therapy (4/13) achieved CR or CRh2
- 50% of patients with prior HMA therapy who achieved CR or CRh (2/4) were in remission at 12 months after initiating treatment2