'Venetoclax in combination with a hypomethylating agent is currently standard treatment for patients with newly diagnosed AML who are unfit for intensive chemotherapy, including those with mIDH1. When this therapy fails, patients historically have had limited treatment options and poor prognoses,' said
'These data support REZLIDHIA's efficacy and well-characterized safety profile in patients with mIDH1 R/R AML who had previously been treated with venetoclax combination regimens,' said
Key points from the paper are summarized below
Olutasidenib alone or in combination with azacitidine demonstrated potential efficacy in patients with AML following failure of venetoclax combination therapy
Of the 18 patients with prior venetoclax treatment, 10 were relapsed, 6 were refractory, and 2 had complete remission with incomplete hematologic recovery (CRi) to a venetoclax combination
Of the 16 R/R patients, 7 (43.8%) achieved a composite complete remission (CRc), 4 (25%) achieved complete remission (CR), and 1 (6.3%) achieved CR with partial hematologic recovery (CRh). Both patients with CRi at study entry achieved CR
Median time to CRc was 1.9 months (range 1-2.8). As of the data cut-off (
Red blood cell and platelet transfusion independence was achieved in 2/12 (17%) and 2/7 (29%) transfusion-dependent R/R patients at baseline, respectively
Safety was consistent with the overall profile of olutasidenib
The paper, titled 'Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML),' was published online in Leukemia & Lymphoma and can be accessed here.
About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The
Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.
About Rigel
Forward-Looking Statements
This press release contains forward-looking statements relating to, among other things, that olutasidenib may provide a meaningful approach to the treatment of Post-Venetoclax Patients with Mutant IDH1 AML. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as 'may', 'potential', 'look forward', 'believe', 'will' and similar expressions in reference to future periods. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the FDA,
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