Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG-221 · 3 trials · 4 indications
The time between randomization and death from any cause. Participants who drop-out or are alive at the end of trial will have their OS times censored at the time of last contact, as appropriate.
Total \[14C\]-radioactivity in whole blood and plasma
Total \[14C\]-radioactivity in urine, and feces (and vomitus, if applicable).
Cumulative excretion of total \[14C\]-radioactivity (as a fraction of the radioactive dose) in urine and feces (and vomitus, if applicable)
Total \[14C\]-radioactivity whole blood-to-plasma ratios
Metabolite profiling / characterization in select plasma, urine, and fecal samples
The analysis for metabolite profiles and characterization are qualitative and there are no units for the analysis.
Maximum observed plasma concentration
Area under the plasma concentration-time curve
Time to maximum observed plasma concentration
Estimate of the terminal elimination half-life
Area under the plasma concentration-time curve from time zero to time t
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Apparent total plasma clearance when dosed orally
Apparent volume of distribution during terminal phase
| Arm | Type | Description |
|---|---|---|
| AG-221 plus Best supportive care (BSC) | EXPERIMENTAL | Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days, plus BSC. |
| Conventional care regimen (CCR) | ACTIVE_COMPARATOR | Continuous 28-day cycles of BSC only, azacitidine subcutaneously (SC) plus BSC, low-dose cytarabine (LDAC) SC plus BSC, or intermediate-dose cytarabine (IDAC) intravenously (IV) plus BSC. Subjects will be assigned by the investigator to one of the CCR treatment options based on the investigator's assessment of subjects' eligibility. |
| 100-mg AG-221 oral solution + a microtracer of [14C]-AG- 221 | EXPERIMENTAL | Subjects will receive a 100 mg AG-221 to be swallowed with 240 mL of room-temperature, non-carbonated water. |
| 100-mg AG-221 tablet + 100 micrograms [14C] AG-221 | EXPERIMENTAL | Formulated tablet containing 100 mg AG-221 + IV solution containing 100 micrograms \[14C\] AG-221 |
| 50 mg AG-221 tablet | EXPERIMENTAL | 50 mg AG-221 tablet given by mouth with 240 mL of non-carbonated, room temperature water, under fasted conditions |
| 100 mg AG-221 tablet | EXPERIMENTAL | 100 mg AG-221 tablet given by mouth with 240 mL of non-carbonated, room temperature water, under fasted conditions |
| 300 mg AG-221 tablet | EXPERIMENTAL | 300 mg AG-221 tablet given by mouth with 240 mL of non-carbonated, room temperature water, under fasted conditions |
| Name | Type | Description |
|---|---|---|
| AG-221 | DRUG | Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days |
| BSC | OTHER | Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support |
| Azacitidine | DRUG | continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC |
| Low-dose cytarabine (LDAC) | DRUG | continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC |
| Intermediate-dose cytarabine (IDAC) | DRUG | 28-day cycles of cytarabine 0.5 to 1.5 g/m2/day IV for 3 to 6 days, per standard institutional practice, plus BSC; only BSC given after IDAC therapy concludes per standard institutional practice |
| 14C AG-221 | RADIATION | 5 mL of 100 micrograms \[14C\] AG-221 given intravenously 4 hours after swallowing the formulated tablet. |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 60 years of age at the time of signing the ICF 2. Subject has primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms (\[MPN\], or therapy-related) AML accor...
AG-221 is an investigational small molecule being studied for the treatment of late stage acute myeloid leukemia in older subjects who harbor an isocitrate dehydrogenase 2 mutation. It has also been studied in healthy volunteers for pharmacokinetic and safety purposes. It is not approved and remains in clinical development.
AG-221 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with acute myeloid leukemia.
AG-221 has completed a Phase 3 clinical trial for late stage acute myeloid leukemia in older subjects with an isocitrate dehydrogenase 2 mutation. It has also completed Phase 1 studies in healthy volunteers. The drug is investigational and not yet approved.
AG-221 has been studied in three completed trials. NCT02577406 is a Phase 3 efficacy and safety study in older subjects with late stage acute myeloid leukemia harboring an IDH2 mutation. NCT02387866 and NCT02443168 are Phase 1 pharmacokinetic and safety studies in healthy male subjects.
AG-221 targets the isocitrate dehydrogenase 2 (IDH2) enzyme. The Phase 3 trial specifically enrolled patients with acute myeloid leukemia harboring an IDH2 mutation, indicating the drug is designed to act on this molecular target.
Yes, AG-221 is also known as CC-90007. The Phase 3 clinical trial NCT02577406 is titled 'An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation.'