Rigel Announces First Patient Enrolled in Phase 1b/2 Triplet Therapy Trial of REZLIDHIA® (olutasidenib) in mIDH1 AML

• First trial in Rigel’s multi-year strategic development alliance with MD Anderson
• Phase 1b/2 trial of decitabine and venetoclax in combination with Rigel’s targeted mIDH1 inhibitor REZLIDHIA for patients with mIDH1 AML

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA^® (olutasidenib) in patients with mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). REZLIDHIA is a potent, selective, oral, small-molecule inhibitor of mIDH1¹, designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells, that is approved for the treatment of relapsed or refractory (R/R) mIDH1 AML.

The clinical trial is sponsored and is being conducted by The University of Texas MD Anderson Cancer Center (MD Anderson) and opened for enrollment in August (NCT06445959). The trial is led by principal investigator Courtney DiNardo, M.D., MSCE, Professor of Leukemia at MD Anderson. It is a multi-center, open-label, non-randomized clinical trial, with the Phase 1b part of the trial seeking to determine the safety and tolerability and recommended Phase 2 dose of oral or intravenous (IV) decitabine and venetoclax in combination with olutasidenib in mIDH1 R/R patients. The Phase 2 part of the trial will include 60 patients and its primary objective is to determine the complete remission rate in both newly diagnosed (n=30) and R/R mIDH1 AML patients (n=30). This is the first trial in Rigel’s multi-year strategic development alliance with MD Anderson.

“We believe REZLIDHIA has strong potential in a wide range of cancers where mIDH1 plays an important role. Studying REZLIDHIA in combination with two widely used agents in AML could provide a new all-oral front-line option to patients who are in urgent need of innovative treatments,” said Raul Rodriguez, Rigel’s president and CEO. “MD Anderson is the ideal partner on this journey to evaluate REZLIDHIA’s impact on AML and other hematological cancers. We are excited to have the first patient enrolled in this initial trial in mIDH1 AML.”   

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