os_post-asco_2023_combo Chart

aThe data cutoff date of the primary analysis from the AGILE study was March 2021 with a median follow-up of 15.1 months for the OS analysis.1,3

bThe data cutoff date of the long-term follow-up analysis from the AGILE study was June 2022 with a median follow-up of 28.6 months for the OS analysis.4

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47% of patients achieved CR on TIBSOVO + azacitidine

(95% CI, 35-59; P<0.0001) vs 15% on azacitidine (95% CI, 8-25)1,a

  • Median duration of CR was not estimable (NE) as of the data cutoff date in the TIBSOVO + azacitidine arm (95% CI, 13.0-NE) and was 11.2 months in the azacitidine arm (95% CI, 3.2-NE)1
  • Of the patients who achieved CR with TIBSOVO + azacitidine, 88% remained in remission at 12 months (95% CI, 67.5-96.2) per Kaplan-Meier estimation2,3
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aCR was 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 transfusions.2


TIBSOVO has a well-characterized safety profile studied in more than 270 patients with mIDH1 AML1

BOXED WARNING: Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. TIBSOVO is associated with the following Warnings and Precautions: differentiation syndrome, QTc prolongation, and Guillain-Barré syndrome.1

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Single-agent TIBSOVO helps achieve multiple treatment goals for your patients with difficult‑to‑treat mIDH1 AML1

In newly diagnosed,
IC‑ineligible AML

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TIBSOVO is the #1 prescribed mIDH1 inhibitor

TIBSOVO has over 5 years of real-world experience1,2

  • Built on a broad body of evidence studied in over 270 mIDH1 AML patients1
  • More than 2170 AML patients have been treated with TIBSOVO since FDA approval in July 20182

See how TIBSOVO + azacitidine delivers strong and durable results1,3

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TIBSOVO offers a straightforward dosing regimen with no titration needed1

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about TIBSOVO for you
and your practice

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Early use of TIBSOVO may offer your mIDH1 AML patients the chance for improved outcomes1,2
AZA, azacitidine; CI, confidence interval; CR, complete remission; HR, hazard ratio; IC, induction chemotherapy; mIDH1, mutated isocitrate dehydrogenase‑1; NCCN, National Comprehensive Cancer Network® (NCCN®); OS, overall survival; R/R, relapsed/refractory.

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Data on file. Servier Pharmaceuticals LLC. 3. Montesinos P, Recher C, Vives S, et al. Ivosidenib and azacitidine in IDH1-mutated acute myeloid leukemia. N Engl J Med. 2022;386(16):1519-1531. doi:10.1056/NEJMoa2117344 4. de Botton S, Montesinos P, Vives Polo S, et al. Updated efficacy and safety data from the AGILE study in patients with newly-diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine. Poster presented at: 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, IL. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed July 26, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 6. Popovici-Muller J, Lemieux RM, Artin E, et al. Discovery of AG-120 (ivosidenib): a first-in-class mutant IDH1 inhibitor for the treatment of IDH1 mutant cancers. ACS Med Chem Lett. 2018;9(4):300-305. doi:10.1021/acsmedchemlett.7b00421
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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



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.