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Rigel Announces Five Poster Presentations at the Upcoming 64th American Society of Hematology Annual Meeting and Exposition
Updated interim analysis from Phase 2 registrational study highlights 35% of mIDH1 R/R AML patients who received olutasidenib achieved CR+CRh with a median
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"Updated interim analysis from Phase 2 registrational study highlights 35% of mIDH1 R/R AML patients who received olutasidenib achieved CR+CRh with a median duration of 25.9 monthsPresentations across the Company's commercial and clinical-stage hematology-oncology portfolio underscore commitment in this spaceSOUTH SAN FRANCISCO, Calif., Nov. 3, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the upcoming presentation of five posters highlighting data from the Company's commercial and clinical-stage hematology-oncology portfolio at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 10-13, 2022, in New Orleans, LA, and virtually.\nThe abstract titled \"Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed/refractory mIDH1 acute myeloid leukemia: Results from a planned interim analysis of a phase 2 pivotal clinical trial\" provides an updated interim analysis from the open-label Phase 2 registrational study of olutasidenib, an investigational, oral, small molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1), in patients with relapsed/refractory acute myeloid leukemia (R/R AML). The registrational cohort of the Phase 2 study enrolled 153 patients with mIDH1 R/R AML who received olutasidenib monotherapy 150 mg twice daily. The efficacy evaluable population was 147 patients who received their first dose at least six months prior to the interim analysis cutoff date of June 18, 2021. The primary endpoint was a composite of complete remission (CR) plus complete remission with partial hematological recovery (CRh). CRh is defined as less than 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and absolute neutrophil count >500/microliter).\nResults from the updated interim analysis of patients with mIDH1 R/R AML demonstrated a 35% CR+CRh rate with a median duration of 25.9 months. The observed activity is clinically meaningful and potentially represents a new therapeutic option in the treatment of this poor prognosis patient population. In this cohort, olutasidenib was well tolerated with an adverse event profile largely characteristic of symptoms or conditions experienced by patients with AML undergoing treatment. Differentiation syndrome was ...