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Rigel Announces Publication of REZLIDHIA™ (olutasidenib) Phase 2 Clinical Results in Blood Advances
˗ REZLIDHIA induced durable remissions in adult patients with mIDH1 R/R AML SOUTH SAN FRANCISCO, Calif., Feb. 2, 2023 /PRNewswire/ -- Rigel Pharmaceuticals,
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"˗ REZLIDHIA induced durable remissions in adult patients with mIDH1 R/R AML\nSOUTH SAN FRANCISCO, Calif., Feb. 2, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a peer-reviewed publication of data in Blood Advances, which summarizes clinical results from the Phase 2 registrational study of REZLIDHIA™ (olutasidenib), a potent, selective, oral, small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1)1, in patients with mIDH1 relapsed or refractory acute myeloid leukemia (R/R AML). The published data demonstrate that REZLIDHIA induced durable remissions and transfusion independence with a well-characterized safety profile. The observed efficacy is clinically meaningful and represents a therapeutic advance in this poor prognosis patient population with limited treatment options. \nThe pivotal cohort of the Phase 2 registrational study enrolled 153 adult patients with mIDH1 R/R AML who received REZLIDHIA monotherapy 150 mg twice daily orally. The efficacy evaluable population included 147 patients with centrally confirmed mIDH1. The primary endpoint was a composite of complete remission (CR) plus complete remission with partial hematologic 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).\nKey findings from the trial are summarized below:\nREZLIDHIA demonstrated a 35% (51/147) CR+CRh rate in mIDH1 R/R AML patients. Of the patients who achieved the primary endpoint of CR+CRh, 92% (47/51) were CR. Most patients who achieved CR or CRh responded early, with a median time to response of 1.9 months. The overall response rate was 48% (71/147). Response rates were similar in patients who had and who had not received prior venetoclax.In patients treated with REZLIDHIA, the median duration of CR+CRh was 25.9 months and the median duration of CR was 28.1 months. The median duration of overall response was 11.7 months.Median overall survival (OS) was 11.6 months in the overall population of 153 patients. In patients who achieved CR+CRh, median OS was not reached and the estimated 18-month survival was 78%.Conversion to transfusion independence (TI), another recognized indicator of clinical benefit, was achieved in 34% of patients...