Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT-2102 · 2 trials · 8 indications
DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting \<72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for \>7 days.
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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).
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.
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.
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).
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).
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%.
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.
| Arm | Type | Description |
|---|---|---|
| Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a) | EXPERIMENTAL | - |
| Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a) | EXPERIMENTAL | - |
| Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b) | EXPERIMENTAL | - |
| Phase 1b and 2 Cohort Combination (Cohort 2b) | EXPERIMENTAL | - |
| Phase 1b and 2 Cohort Combination (Cohort 4b) | EXPERIMENTAL | - |
| PH1 Dose Escalation & Expansion FT-2102 (olutasidenib) | EXPERIMENTAL | - |
| PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine | EXPERIMENTAL | - |
| PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine | EXPERIMENTAL | - |
| PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent | EXPERIMENTAL | Relapsed or Refractory (R/R) AML |
| PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent | EXPERIMENTAL | AML 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 Agent | EXPERIMENTAL | R/R AML/MDS, previously treated with FT-2102 |
| PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine | EXPERIMENTAL | R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy |
| PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine | EXPERIMENTAL | R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy |
| PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine | EXPERIMENTAL | R/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 Agent | EXPERIMENTAL | Treatment naïve AML for whom standard treatments are contraindicated |
| PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine | EXPERIMENTAL | Treatment naïve AML who are candidates for azacitidine first line treatment |
| Name | Type | Description |
|---|---|---|
| FT-2102 | DRUG | FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level. |
| Azacitidine | DRUG | Azacitidine will be administered per the site's standard of care. |
| Nivolumab | BIOLOGICAL | Nivolumab will be administered per the site's standard of care. |
| Gemcitabine and Cisplatin | DRUG | Gemcitabine and cisplatin will be administered per the site's standard of care. |
| FT-2102 (olutasidenib) | DRUG | FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level |
| Cytarabine | DRUG | low-dose cytarabine will be administered per site's standard of care |
Key Inclusion Criteria: * Patients must have documented IDH1-R132 gene-mutated disease as evaluated by site * Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy. * Hepatobiliary cancer that is relapsed/refractory or into...
FT-2102 is an investigational small molecule being studied for the treatment of IDH1-mutant cancers, including acute myeloid leukemia, myelodysplastic syndrome, advanced gliomas, glioblastoma multiforme, and other solid tumors such as hepatocellular carcinoma, cholangiocarcinoma, and chondrosarcoma. It is currently in Phase 1 clinical development.
FT-2102 targets cancers that harbor an IDH1 mutation. It is being studied in biomarker-selected patient populations with IDH1-mutant tumors, including acute myeloid leukemia, gliomas, and other solid tumors. The drug is designed to act on this specific genetic alteration.
FT-2102 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The drug is currently in Phase 1 clinical trials for oncology indications.
FT-2102 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in acute myeloid leukemia and myelodysplastic syndrome and another in advanced solid tumors and gliomas.
FT-2102 has been studied in two completed Phase 1 trials. NCT02719574 evaluated FT-2102 with or without azacitidine or cytarabine in patients with AML or MDS with an IDH1 mutation. NCT03684811 studied FT-2102 in patients with advanced solid tumors and gliomas with an IDH1 mutation.
FT-2102 is also known by the name olutasidenib. It is an investigational small molecule being developed by Novo Nordisk A/S for the treatment of IDH1-mutant cancers, including acute myeloid leukemia and gliomas.