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Now approved FOR PATIENTS WITH R/R MDS

TIBSOVO® is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (R/R MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Press Release Prescribing Information
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TIBSOVO (ivosidenib tablets) 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

Many patients in the study had challenging disease characteristics1,2

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58% of patients had ≥2 prior anticancer therapies2

  • Median number of prior therapies (min, max): 2 (1, 6)1

33% of patients had secondary AML1

23% of patients had prior stem cell transplantation for AML1

87% of patients had intermediate or poor cytogenic risk status1

Study design

AML, acute myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IDH1, isocitrate dehydrogenase‑1; RBC, red blood cell.

TIBSOVO delivered strong responses as a once-daily oral treatment in a difficult-to-treat disease

33 Chart 33 Chart
  • CR+CRh rate appeared to be consistent across all baseline demographics and baseline disease characteristics with the exception of number of prior regimens1

bCR 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.1,2 CRh was 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).

Patients achieved CR or CRh after receiving 1 or more prior regimens2

47 Circle

47% of R/R patients who had received 1 prior regimen (35/74) achieved CR or CRh (95% CI, 35.6-59.3)2

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30% of R/R patients who had received 2 prior regimens (15/50) achieved CR or CRh (95% CI, 17.9-44.6)2

15 Circle

15% of R/R patients who had received ≥3 prior regimens (7/48) achieved CR or CRh (95% CI, 6.1-27.8)2

AML, acute myeloid leukemia; CR, complete remission; CRh, complete remission with partial hematological recovery; R/R, relapsed/refractory.

TIBSOVO provided durable responses1

Median duration of response1,c

RR Chart RR Mobile Chart

cDuration of CR and CR+CRh were defined as time since first response of CR or CR/CRh, respectively, to relapse or death, whichever was earlier.1

36% of patients who achieved CR or CRh were in remission at 12 months after initiating treatment2
  • Median treatment duration: 4.1 months (range, 0.1-39.5)1
    • Some patients experienced long treatment durations of over 3 years with TIBSOVO (range, 0.2-39.5 months)1
  • Median follow-up: 8.3 months (range, 0.2-39.5)1

CR, complete remission; CRh, complete remission with partial hematological recovery.

TIBSOVO enabled strong and rapid responses1,3

Time to response in patients who achieved CR or CRh

RR Timeline Chart RR Timeline Mobile Chart
For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response1

CR, complete remission; CRh, complete remission with partial hematological recovery.

Transfusion independence was seen in 37% of transfusion-dependent patients who received TIBSOVO1

37-transfusion-chart Chart 37-transfusion-chart Chart
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 period.1

RBC, red blood cell.

Overall survival results3

Overall survival (OS) according to response3

os-survival-chart Chart os-survival-chart Chart
  • Median OS was 8.8 months (95% CI, 6.7-10.2) with a median follow-up of 14.8 months (range, 0.2-30.3)
    • Because there was no control arm in this study, OS results should be interpreted cautiously
  • Median OS was not reached by the data cutoff date for patients who achieved CR or CRh

CR, complete remission; CRh, complete remission with partial hematological recovery.

TIBSOVO improved hematologic parameters3

TIBSOVO demonstrated an improvement in hematologic variables together with a reduction in bone marrow blasts

Increase in mean platelet count and mean absolute neutrophil counts

increased-mean-platelet Chart increased-mean-platelet Chart

Increase in mean hemoglobin level, decrease in mean bone marrow blasts

increased-mean-hemoglobin Chart increased-mean-hemoglobin Chart

Adapted with permission from DiNardo et al.3

Data are mean values with standard deviations.

12% of patients (21/174) went on to receive a stem cell transplant following treatment with TIBSOVO1
Learn about the TIBSOVO safety profile

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 2. Data on file. Servier Pharmaceuticals LLC. 3. DiNardo CD, Stein EM, de Botton S, et al. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018;378(25):2386-2398. doi:10.1056/NEJMoa1716984

TIBSOVO® was studied as a single agent in both the newly diagnosed and R/R AML settings1

TIBSOVO is a first-in-class agent that inhibits the mutant IDH1 enzyme to induce myeloid differentiation1,2

  • The pivotal trial for TIBSOVO monotherapy was an open-label, single-arm, multicenter trial1
  • IDH1 mutations were identified by a local or central diagnostic test and confirmed retrospectively using the Abbott RealTime IDH1 assay, which is the FDA-approved test for selection of patients with AML for treatment with TIBSOVO1,3
Patients were assigned a starting dose of TIBSOVO 500 mg daily and received treatment until disease progression, development of unacceptable toxicity, or undergoing hematopoietic stem cell transplantation1
  • 28 IC-ineligible patients with newly diagnosed AML were evaluated for safety and efficacy
  • 179 patients were evaluated for safety and 174 for efficacy in the R/R AML population

Efficacy was established based on the rate of CR and/or CRh, duration of CR+CRh, as well as the rate of conversion from transfusion dependence to transfusion independence1,a

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 CRh was 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).
AML, acute myeloid leukemia; CR, complete remission; CRh, complete remission with partial hematological recovery; IC, induction chemotherapy; IDH1, isocitrate dehydrogenase-1; R/R, relapsed or refractory.1
References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 2. Data on file. Servier Pharmaceuticals LLC. 3. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). U.S. Food and Drug Administration. Updated March 15, 2023. Accessed April 20, 2023. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
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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

Relapsed or Refractory Myelodysplastic Syndromes (MDS)

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

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS
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 and MDS: 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 (eg, 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

  • In patients with AML, the most common adverse reactions including laboratory abnormalities (≥25%) 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
  • In patients with MDS, the most common adverse reactions including laboratory abnormalities (≥25%) are creatinine increased, hemoglobin decreased, arthralgia, albumin decreased, aspartate aminotransferase increased, fatigue, diarrhea, cough, sodium decreased, mucositis, decreased appetite, myalgia, phosphate decreased, pruritus, and rash

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 and MDS patients.

 

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 AND MDS

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.