TIBSOVO® was studied in a patient population reflective of that seen in clinical practice1
Selected baseline demographic and disease characteristics (N=174)1 | |
---|---|
Median age (years) (min, max) | 67 (18, 87) |
ECOG PS | |
0 | 21% |
1 | 56% |
2 | 22% |
3 | 1% |
IDH1 mutation | |
R132C | 59% |
R132H | 25% |
R132G | 7% |
R132S | 6% |
R132L | 4% |
Cytogenetic risk status | |
Intermediate | 60% |
Poor | 27% |
Missing/unknown | 13% |
Relapse type | |
Primary refractory | 37% |
Refractory relapse | 26% |
Untreated relapse | 37% |
Prior stem cell transplantation for AML | 23% |
Transfusion dependent at baselinea | 63% |
Type of AML | |
De novo AML | 67% |
Secondary AML | 33% |
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 | |
ECOG PS, Eastern Cooperative Oncology Group Performance Status. |
Many patients in the study had challenging disease characteristics1,2

26%
of patients who were refractory in relapse1
37%
of patients who were primary refractory1
58% of patients had ≥2 prior anticancer therapies2
- Median number of prior therapies (min, max): 2 (1, 6)1
23% of patients had prior stem cell transplantation for AML1
33% of patients had secondary AML1
TIBSOVO delivered strong and durable responses as an oral, single agent in difficult-to-treat disease1

- 24.7% CR rate (43/174) (95% CI, 18.5-31.8);
8.0% CRh rate (14/174) (95% CI, 4.5-13.1)1 - CR+CRh rate appeared to be consistent across all baseline demographic and baseline disease characteristics with the exception of number of prior regimens1
- For patients who achieved CR or CRh, the median time to CR or CRh was 2 months (range, 0.9-5.6 months)1

- Median treatment duration: 4.1 months (range, 0.1-39.5 months)1
- Median follow-up: 8.3 months (range, 0.2-39.5 months)1
Transfusion independence was seen in 37% of transfusion-dependent patients who received TIBSOVO1

-
20.0% (22/110)
Patients who achieved CR or CRh2
-
17.3% (19/110)
Patients who did not achieve CR or CRh2
- 59% of patients who were transfusion independent at baseline (38/64) remained so1
- Patients were defined as transfusion dependent at baseline if they received any RBC or platelet transfusions 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-consecutive day postbaseline period1