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FT-2102

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Novo Nordisk A/S|Last Updated: Jun 26, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment336
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02719574Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 MutationPHASE1 COMPLETED 336Apr 30, 2016Jan 24, 2024Jun 26, 202560 United States, Australia +7
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Study Endpoints
Primary Endpoints
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)

Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.

Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)

Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.

Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).

Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).

Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.

Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)

RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.

Secondary Endpoints
Phase 1: Area Under the Curve (AUClast) for FT-2102
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)EXPERIMENTAL -
PH1 Esc. and Exp. FT-2102 (olutasidenib)+AzacitidineEXPERIMENTAL -
PH1 Esc. and Exp. FT-2102 (olutasidenib)+CytarabineEXPERIMENTAL -
PH2 Cohort 1 FT-2102 (olutasidenib) Single AgentEXPERIMENTALRelapsed or Refractory (R/R) AML
PH2 Cohort 2 FT-2102 (olutasidenib) Single AgentEXPERIMENTALAML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
PH2 Cohort 3 FT-2102 (olutasidenib) Single AgentEXPERIMENTALR/R AML/MDS, previously treated with FT-2102
PH2 Cohort 4 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALR/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
PH2 Cohort 5 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALR/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
PH2 Cohort 6 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALR/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
PH2 Cohort 7 FT-2102 (olutasidenib) Single AgentEXPERIMENTALTreatment naïve AML for whom standard treatments are contraindicated
PH2 Cohort 8 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALTreatment naïve AML who are candidates for azacitidine first line treatment
Interventions
NameTypeDescription
FT-2102 (olutasidenib)DRUGFT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
AzacitidineDRUGazacitidine will be administered per site's standard of care
CytarabineDRUGlow-dose cytarabine will be administered per site's standard of care
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia \[APL\] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised I...

Countries:United StatesAustraliaCanadaFranceGermanyItalySouth KoreaSpainUnited Kingdom
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