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Now approved in combination with azacitidine

For patients with newly diagnosed aml

TIBSOVO® is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

Prescribing Information Press Release more
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AGILE study design1

study-design-combo-modal study-design-combo-modal
  • Efficacy was established on the basis of event-free survival (EFS), overall survival (OS), and rate and duration of complete remission (CR)2
  • EFS was defined as time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurred first2
  • Treatment failure was defined as failure to achieve CR by Week 24. A CRh response was considered to be a treatment failure2
The trial was initially powered for 200 participants. However, the Independent Data Monitoring Committee suggested halting enrollment after 146 patients when a clinically important difference between the two treatment groups was achieved.3
AML, acute myeloid leukemia; CR, complete remission, defined as <5% blasts in the bone marrow and no Auer rods, absence of extramedullary disease, full recovery of peripheral blood counts (absolute neutrophil count ≥1000/μL and platelets ≥100,000/μL), and independence of red blood cell transfusions3; CRh, complete remission with partial hematological recovery, defined as <5% blasts in the bone marrow and no Auer rods, absence of extramedullary disease, and partial recovery of peripheral blood counts (absolute neutrophil count >500/μL and platelets >50,000/μL)3; ECOG PS, Eastern Cooperative Oncology Group Performance Status; EORTC QLC-C30, European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire; EQ-5D-FL, 5-level EuroQol Five Dimensions Questionnaire (descriptive system and visual analogue scale); HMA, hypomethylating agent; IV, intravenous; LVEF, left ventricular ejection fraction; mIDH1, mutated isocitrate dehydrogenase-1; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; ORR, objective response rate; QD, once a day; SC subcutaneous.

References: 1. Montesinos P, Recher C, Zarzycka E, et al. AGILE: A phase 3, double-blind, randomized, placebo-controlled study of ivosidenib in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia and an IDH1 mutation. Poster presented at: 3rd International Academy for Clinical Hematology (IACH) Annual Meeting; October 1-3, 2020; virtual. 2. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 3. Data on file. Servier Pharmaceuticals LLC.

Baseline patient demographics and disease characteristics1
  TIBSOVO® (500 mg daily)
+ azacitidine (n=72)
Placebo + azacitidine
(n=74)
Demographics
Median age, years (min, max) 76 (58, 84) 76 (45, 94)
Age categories, n (%)
<65 years 4 (6) 4 (5)
≥65 years to <75 years 29 (40) 40 (54)
≥75 years 39 (54) 43 (58)
Disease characteristics
ECOG PS, n (%)
0 14 (19) 10 (14)
1 32 (44) 40 (54)
2 26 (36) 24 (32)
Cytogenetic risk status,a n (%)
Favorable 3 (4) 7 (9)
Intermediate 48 (67) 44 (59)
Poor 16 (22) 20 (27)
Other 3 (4) 1 (1)
Missing 2 (3) 2 (3)
Transfusion dependent at baseline,b n (%) 39 (54) 40 (54)
Type of AML, %
de novo AML 54 (75) 53 (72)
Secondary AML 18 (25) 21 (28)
Therapy-related AML 2 (3) 1 (1)
MDS related 10 (14) 12 (16)
MPN related 4 (6) 8 (11)

AML, acute myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group Performance Status; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; NCCN, National Comprehensive Cancer Network®.

aCytogenic risk status: Investigators used the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).

bPatients were defined as transfusion dependent if they received any red blood cell or platelet transfusion within 56 days prior to the first dose of study treatment.

Reference: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022.

 

INDICATIONS

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with:

Newly Diagnosed Acute Myeloid Leukemia (AML)

  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy
  • Adult patients with relapsed or refractory AML.
Indications & Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.