TIBSOVO is the first and only FDA-approved therapy to target mIDH1 in R/R MDS1,2
TIBSOVO was evaluated in adult patients with R/R mIDH1 MDS in an open-label, single-arm, multicenter study.1
Study design Baseline characteristicsmIDH1, mutated isocitrate dehydrogenase-1; R/R, relapsed or refractory.
TIBSOVO demonstrated deep and durable remissions1,3
39%
- Rapid remissions: median time to CR was 1.9 months (range, 1.0-5.6)1
Durability of remissions with TIBSOVO
- Median duration of CR was not reached by data cutoff (range, 1.9-80.8+ months; 95% CI, 1.9-NE)1,3,b
- 69% of patients who achieved CR were estimated to remain in remission at 6 years4,c
Patients treated with TIBSOVO achieved hematologic improvements, including rapid neutrophil recovery3,4
- Rapid and sustained neutrophil recovery was seen in patients, regardless of the treatment response status4,5
- Among patients who didn't achieve CR, more than half (4/7) experienced rapid neutrophil recovery in a median time of 0.97 months4,5
- Of the 8 patients who experienced marrow CR, 50% experienced hematologic improvements in ≥1 lineage including RBC, platelet, and/or neutrophil3,d
- One (6%) patient went on to receive stem cell transplantation following treatment with TIBSOVO3
aCR was defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines, hemoglobin ≥11 g/dL, platelets ≥100 x 109/L, neutrophils ≥1.0 x 109/L, and response lasting at least 4 weeks.3,4 43% of CR responders had baseline bone marrow blasts <5%.1
bDOCR was derived based on Kaplan-Meier method and is the date of the first documented CR (lasting ≥4 weeks) to the date of the first documented relapse or death, whichever was earlier.1 Plus sign (+) indicates a censored observation.
cPer Kaplan-Meier estimation.4
d Of those experiencing hematologic improvements in >1 lineage, 25% (2/8) had improved erythrocyte counts, 25% (2/8) had improved platelet counts, and 50% (4/8) had improved neutrophil counts.3
DOCR, duration of CR; HCT, hematopoietic stem cell transplantation; HMA, hypomethylating agent; IC, intensive chemotherapy, INV, investigational agent; mCR, marrow CR; NE, not estimable; PD, progressive disease; PR, partial remission; PT, prior therapy; SD, stable disease.
Majority of patients achieved or maintained transfusion independence with TIBSOVO1,e

Median time to transfusion independence was 2.43 months in patients who were transfusion-dependent at baseline.3,4
- 100% of patients who were platelet transfusion-independent at baseline maintained transfusion independence3
Duration of transfusion independence with TIBSOVO3
- 67% of patients (4/6) who were baseline transfusion dependent and achieved transfusion independence had a duration of transfusion independence >4 months, with the longest lasting 272+ days and maintained through the end of treatment4
- Of the 72% of patients who achieved or maintained transfusion independence, median duration of transfusion independence was not reached but ranged between 1.9 and 78.8 months3,4,e,f
ePostbaseline transfusion independence was defined as a period of ≥56 days with no red blood cell and/or platelet transfusions after the start of study treatment and on or before the end of study treatment.3,4
fNine observations were censored.4
Overall survival with TIBSOVO4
Median OS was estimated to be 35.7 months4
- Median OS follow-up was 27.1 months4
- 87% survival rate at 12 months per Kaplan-Meier estimation4
- Because there was no control arm in this study, OS results should be interpreted cautiously1
AML, acute myeloid leukemia; OS, overall survival.
References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023 2. Servier announces FDA approval of TIBSOVO® (ivosidenib tablets) for the treatment of IDH1-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). Servier Pharmaceuticals LLC. Published October 24, 2023. Accessed March 16, 2024. https://servier.us/blog/servier-announces-fda-approval-of-tibsovo-ivosidenib-tablets-for-the-treatment-of-idh1-mutated-relapsed-or-refractory-r-r-myelodysplastic-syndromes-mds/ 3. DiNardo CD, Roboz GJ, Watts JM, et al. Final phase I substudy results of ivosidenib in patients with mutant IDH1 relapsed/refractory myelodysplastic syndrome. Blood Adv. 2024;8(15):4209-4220. doi:10.1182/bloodadvances.2023012302 4. Data on file. Servier Pharmaceuticals LLC. 5. Prince GT, Baratam P, Garcia-Monero G, et al. Improved hematologic recovery with ivosidenib in patients with mIDH1 relapsed or refractory MDS: Results from a Phase 1 substudy. Blood. 2024;144 (Suppl 1): 3226. doi:10.1182/blood-2024-209071