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Daiichi Sankyo Company, Limited: Phase 1/2 Trial Initiated for Daiichi Sankyo's Menin Inhibitor DS-1594 in Patients with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia


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Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo) today announced the first patient has been dosed in the first-in-human phase 1/2 study of DS-1594, a selective small-molecule menin inhibitor, in adults with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial is being conducted by The University of Texas MD Anderson Cancer Center under an existing strategic research collaboration.
Inhibition of the menin protein is being studied as a novel treatment approach for acute leukemias with MLL rearrangement (MLLr) or NPM1 mutation (NPM1m), two gene alterations that drive cancer development and growth.
1 MLLr occurs in approximately 5 to 10% of acute leukemia patients and is associated with aggressive disease, reduced treatment response and poor prognosis. ....

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Daiichi Sankyo Company, Limited: DESTINY-CRC02 Phase 2 Trial of ENHERTU Initiated in Patients with HER2 Overexpressing Advanced Colorectal Cancer


Daiichi Sankyo Company, Limited: DESTINY-CRC02 Phase 2 Trial of ENHERTU Initiated in Patients with HER2 Overexpressing Advanced Colorectal Cancer
Interstitial Lung Disease Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in =28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., =0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/ ....

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