An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.

Inclusion Criteria:

• Has untreated Acute Myeloid Leukemia (AML)

• Have a documented IDH1 R132 gene-mutated disease

• Have at least one of the following making yourself ineligible for intensivechemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group PerformanceStatus (ECOG PS) of 2, or any comorbidity that the investigator judges to beincompatible with IC including but not limited to severe cardiac or pulmonarydisorder, creatinine clearance less than 45 mL/minute, or bilirubin greater than 1.5times the upper limit of normal

• Has adequate hepatic (liver) and renal (kidney) function

• Female participants of reproductive potential must have a negative blood pregnancytest and must use effective contraception during treatment and for at least 6 monthsfollowing treatment

• Fertile male participants with female partners of reproductive potential must useeffective contraception during treatment and for at least 3 months followingtreatment

Exclusion Criteria:

• Has received any prior treatment for AML, with the exception of hydroxyurea orleukapheresis for white blood cell count control

• Has received prior treatment with an IDH1 inhibitor

• Is a woman who is pregnant or breastfeeding

• Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus [HIV], active hepatitis B (HBV), orhepatitis C virus [HCV]) without improvement despite appropriate antibiotics,antiviral therapy, and/or other treatment

• Has had significant active cardiac disease within 6 months prior to the start ofstudy treatment, including Class III or IV congestive heart failure, myocardialinfarction (heart attack), unstable angina (chest pain), and/or stroke

• Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomachparalysis), or any other condition that limits the ingestion or gastrointestinalabsorption of orally administered drugs

• Has uncontrolled hypertension (high blood pressure)