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New Indication: Oral azacytidine for low-risk MDS - Altai Oncology

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New Indication: Oral azacytidine for low-risk MDS

New Indication: Oral azacytidine for low-risk MDS
  • Placebo-controlled phase III trial
  • IPSS-defined low-risk MDS with anemia and thrombocytopenia
  • Oral azacytidine 300 mg (21/28 days) vs. placebo
  • RBC-Transfusion independence (TI) >56 days: 30.8% vs. 11.1% (OR: 3.6 [1.7-7.4])
  • Median duration for RBC-TI: 11.1 vs 5.0 mos (NS)
  • Hematological improvement in RBCs: 43.0% vs. 31.5% (NS)
  • Median OS: 17.3 vs. 16.2 mos (NS)
  • Grade >=3 AEs: neutropenia (47% vs. 12%), febrile neutropenia (28% vs. 10%), thrombocytopenia (29% vs. 16%), pneumonia (12% vs. 9%)

J Clin Oncol. Mar 25, 2021.

Garcia-Manero G, et al. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes


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