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Rigel Announces Publication of Early Clinical Data of Olutasidenib in The Lancet Haematology
Early clinical data support olutasidenib's potential as a treatment for AML and MDS, in both the relapsed/refractory and newly diagnosed settingsOlutasidenib
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"Early clinical data support olutasidenib's potential as a treatment for AML and MDS, in both the relapsed/refractory and newly diagnosed settingsOlutasidenib showed durable remission in treatment-naïve and relapsed/refractory AML patients, with or without azacitidinePDUFA target action date is February 15, 2023SOUTH SAN FRANCISCO, Calif., Nov. 10, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the publication of data in The Lancet Haematology, which summarizes the Phase 1 results of the Phase 1/2 study of olutasidenib, an investigational, oral, small molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1). Olutasidenib was assessed as a monotherapy or in combination with azacitidine, in patients with mIDH1 acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The published data suggest that olutasidenib, with or without azacitidine, was well-tolerated and was associated with improvements in clinical efficacy endpoints in patients with mIDH1 AML.\n\"These data from the first phase of the Phase 1/2 study suggest that olutasidenib may be both efficacious and well-tolerated, findings that are reinforced by the subsequently reported data from the Phase 2 registrational trial, which generated compelling efficacy and safety data that highlight olutasidenib as a potential treatment option for mIDH1 relapsed/refractory AML,\" said Wolfgang Dummer, M.D., Ph.D., Rigel's chief medical officer. \"The NDA for olutasidenib, submitted by Forma Therapeutics, is under FDA review and we look forward to a potential approval in early 2023.\"\nThe objectives of the first phase of the multi-center, open-label Phase 1/2 study were to assess the safety, pharmacokinetic and pharmacodynamic profile, and clinical activity of olutasidenib, both as monotherapy and in combination with azacitidine, in patients with treatment-naïve or relapsed/refractory (R/R) AML or MDS harboring IDH1 mutations.\nKey findings from the study are summarized below:\nAmong patients receiving combination therapy, treatment-naïve AML patients saw a 77% overall response rate (ORR) and a 54% complete response (CR) plus CR with partial hematological recovery (CR/CRh). These results provide strong rationale for future evaluation of either sequential or triplet therapy in this setting.In the MDS cohort, 4 of 9 responding patients achieve...