Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy

Olutasidenib will be supplied as 150 mg capsules to be administered orally, twice per day (BID) on an empty stomach (fasting at least 1 hour before or 2 hours after a meal), starting on Cycle 1 Day 1, and will be given continuously.

"Participants will receive Venetoclax as a 100mg tablet to be self-administered orally with a meal and water once daily, two hours after starting Olutasidenib administration, starting on Cycle 1 Day 1. The dosing regimen of Venetoclax is as follows:~* Cycle 1: Days 1 - 21 over a 28-day cycle~* Cycle 1 Week 1: Ramp-up dosing schedule up to 400mg (4 x 100mg/tablet)~* For participants with blast clearance: Cycle 2 and beyond: Days 1 - 14 over a 28-day cycle~* For participants with persistent clearance: Cycle 2 through 4: Days 1 - 21"

Participants will receive Azacitidine 75 mg/m2 per day via subcutaneous (SC) injection or intravenous (IV) infusion on Days 1-7 of each cycle.