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Real-world assessment of TIBSOVO + AZA in newly diagnosed AML

TIBSOVO + AZA was compared to venetoclax (VEN) + HMA in a retrospective U.S. chart review of patients with newly diagnosed, IC-ineligible mIDH1 AML1,a

Baseline characteristics were similar for both regimens, with the exception of ELN cytogenetic risk categories1,b

Median time from diagnosis to treatment was 14 days with TIBSOVO + AZA vs 20 days with VEN + HMA1

  • Median mIDH1 testing turnaround time was 7 days in both cohorts1

Study limitations

  • Utilization of real-world evidence to compare treatment regimens may be misleading because of potential bias in the healthcare professional and/or patient selection of therapies and low internal validity.
  • Only 22.8% of patients treated with VEN + HMA received the full FDA-approved 28 days of VEN during the 28-day cycles and 44.6% did not receive >11 days of VEN per cycle.2 This may have impacted the outcomes observed in the VEN + HMA cohort.
  • Because of the limitations of this analysis, comparisons between regimens should not be made.

Efficacy

Observed rates of CR and CR + CRi/p for TIBSOVO + AZA vs VEN + HMA1,c

Bar graph showing CR and CRi/p for TIBSOVO + AZA (41% CR and 63% CR + CRi/p) compared against VEN + HMA (27% CR and 50% CR + CRi/p). Bar graph showing CR and CRi/p for TIBSOVO + AZA (41% CR and 63% CR + CRi/p) compared against VEN + HMA (27% CR and 50% CR + CRi/p).
  • Median time to best response was 3.2 months with TIBSOVO + AZA vs 4.1 months with VEN + HMA1
    • Median time to first BM biopsy was 50 days with TIBSOVO + AZA and 61 days with VEN + HMA; therefore, any earlier responses that may have occurred would not have been recorded

The efficacy of TIBSOVO + AZA observed in this real-world assessment was consistent with the efficacy demonstrated in the AGILE study1,3,4

Observed 6-month EFS rate for TIBSOVO + AZA vs VEN + HMA1,c

Bar graph showing 6-month EFS rate for TIBSOVO + AZA (55%) compared to VEN + HMA (40%).

Rate of patients proceeding to allogeneic stem cell transplant for TIBSOVO + AZA vs VEN + HMA1

Bar graph showing rate of patients proceeding to allogeneic stem cell transplant for TIBSOVO + AZA (12%) compared to VEN + HMA (5%).

Safety

Safety observations with TIBSOVO + AZA vs VEN + HMA1

  • The most common Grade 3+ adverse events were thrombocytopenia (13% with TIBSOVO + AZA vs 10% with VEN + HMA), febrile neutropenia (13% with TIBSOVO + AZA vs 13% with VEN + HMA), neutropenia (13% with TIBSOVO + AZA vs 10% with VEN + HMA), and infection (8% with TIBSOVO + AZA vs 11% with VEN + HMA)
  • Unscheduled acute care within the first 12 weeks was needed for 40% of patients treated with TIBSOVO + AZA vs 70% of patients treated with VEN + HMA
  • Differentiation syndrome was observed in 2 patients (1.4%) treated with TIBSOVO + AZA
  • Treatment discontinuation was 37% for the TIBSOVO + AZA regimen and 38% for the VEN + HMA regimen

A short delay from diagnosis to treatment to obtain molecular test results does not affect patient outcomes.5 Test your patients at diagnosis to consider TIBSOVO + AZA as the front-line treatment of choice for patients with newly diagnosed, IC-ineligible mIDH1 AML6

a This retrospective subgroup analysis compares TIBSOVO + AZA (n=143) vs VEN + HMA (n=101). The TIBSOVO + AZA cohort is a subset of a larger patient population (n=182) that was previously presented. Treatment was delivered in both community and academic settings from November 2021 through November 2022 with a minimum follow-up of 6 months. Collected data included baseline patient and practice characteristics, mutational testing, treatment patterns and rationale, and efficacy and safety outcomes. Endpoints focused on events likely to occur within 6 months of follow-up, including response rates, tolerability, bridge to transplant, and acute care episodes.1,2

b ELN cytogenetic risk status was favorable for 25% vs 13%, intermediate for 56% vs 65%, poor for 16% vs 14%, and not assessed for 3% vs 8% of patients treated with TIBSOVO + AZA vs VEN + HMA, respectively. For the TIBSOVO + AZA and VEN + HMA cohorts, median age was 61 and 65 years, respectively, and 69% and 61% were male, respectively. Prior myelodysplastic syndromes, myeloproliferative neoplasms, sAML, or sAML-like mutations occurred in 39% of patients treated with TIBSOVO + AZA vs 34% of patients treated with VEN + HMA.1

c EFS is defined as CR within 24 weeks, and no relapse or death.

AML, acute myeloid leukemia; AZA, azacitidine; BM, bone marrow; CR, complete response; CRi/p, CR with incomplete count recovery or incomplete platelet recovery; EFS, event-free survival; ELN, European LeukemiaNet; HMA, hypomethylating agent; IC, induction chemotherapy; IDH1, isocitrate dehydrogenase‑1; mIDH1, mutated IDH1; sAML, secondary AML; VEN, venetoclax.

TIBSOVO monotherapy in newly diagnosed AML

References: 1. Data on File. Servier Pharmaceuticals LLC. 2. Smith BD, Lachowiez CA, Ambinder AJ, et al. A Comparison of Acute Myeloid Leukemia (AML) Regimens: Hypomethylating Agents Combined with Ivosidenib or Venetoclax in Newly Diagnosed Patients with IDH1 Mutations: A Real-World Evidence Study. Blood. 2023;142(Supplement 1):971. doi:10.1182/blood.2023.173033 3. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 4. 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 5. Baden D, Zukunft S, Hernandez G, et al. Time from diagnosis to treatment has no impact on survival in newly diagnosed acute myeloid leukemia treated with venetoclax-based regimens. Haematologica. 2024;109(8):2469-2477. doi:10.3324/haematol.2024.285225 6. Montesinos P, Marchione DM, Recher C, et al. Long-term results from the AGILE study of azacitidine plus ivosidenib vs placebo in newly diagnosed IDH1-mutated AML. Blood Adv. 2025;9(20):5177-5189. doi:10.1182/bloodadvances.2025016399

 

Indications

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (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 use of intensive induction chemotherapy

Relapsed or Refractory AML

  • For the treatment of adult patients with relapsed or refractory AML

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.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome in AML: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.

Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with TIBSOVO. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

The most common adverse reactions including laboratory abnormalities (≥25%) in patients with AML are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia.

DRUG INTERACTIONS

Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.

Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.

Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.

QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION

Advise women not to breastfeed.

Please see Full Prescribing Information, including BOXED WARNING for AML patients.

Last update: September 2026

Information on this website is reviewed through established medical, legal, and regulatory processes to support accurate, balanced, and label‑consistent communication about TIBSOVO.

 

INDICATIONS

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (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
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.