SOUTH SAN FRANCISCO - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a peer-reviewed publication in Leukemia & Lymphoma on data from an analysis of the Phase 2 study evaluating REZLIDHIA (olutasidenib), a potent, selective, oral, small-molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1)1, in patients with mIDH1 acute myeloid leukemia (AML) who were relapsed/refractory (R/R) to prior venetoclax-based regimens.

'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 Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator. 'The findings from these analyses suggest that REZLIDHIA may provide an effective treatment for patients with AML following failure of venetoclax combination therapy. REZLIDHIA induced durable remissions consistent with those observed in the pivotal trial and had a favorable tolerability profile in this challenging to treat patient population, representing a valuable treatment option.'

'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 Raul Rodriguez, Rigel's president and CEO. 'These analyses are important because they provide valuable insights into the potential benefit of REZLIDHIA in different segments of the mIDH1 R/R AML patient population.'

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 (June 18, 2021), median duration of CRc was not reached (range, 1.2-NR, ongoing at 30.4+ months)

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 American Cancer Society estimates that there will be about 20,800 new cases in the United States, most in adults, in 2024.2

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

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California.

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, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.

Contact:

Tel: 650.624.1232

Email: ir@rigel.com

David Rosen

Tel: 212.600.1902

Email: david.rosen@argotpartners.com

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