Rigel Pharmaceuticals, Inc. announced promising 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. The data are being presented in a poster at the EHA2023 Hybrid Congress.
“We are encouraged by the strong efficacy and safety results from olutasidenib in patients with mIDH1 R/R AML who had previously been treated with venetoclax combination regimens, a standard treatment for patients unfit for chemotherapy,” said Raul Rodriguez, Rigel’s president and CEO. “These data reinforce REZLIDHIA as a valuable treatment option for these patients, a historically challenging population to treat.”
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“The data from patients who were relapsed/refractory to prior venetoclax combination-based regimens enrolled in the Phase 2 study of REZLIDHIA (olutasidenib) in patients with mIDHl1 AML is promising and appears clinically meaningful,” 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. “With the trial’s compelling data in duration of response and favorable tolerability profile, REZLIDHIA is an important treatment option for these patients, including those who have received prior venetoclax.”
The poster titled “Olutasidenib in Post-Venetoclax Patients with Mutant IDH1 AML” examines a subset of 17 patients from the Phase 2 study of olutasidenib who had previously received venetoclax combination regimens. Key points from the presentation are summarized below:
- Olutasidenib induced durable remissions in patients with mIDH1 R/R AML, including those failing prior treatment with a venetoclax-based regimen
- Of the 17 patients with prior venetoclax treatment, 5 were ongoing and 12 discontinued treatment as of the analysis cutoff date of June 18, 2021
- The best response to olutasidenib was CR/CRh in 5/17 (29.4%), of which 4 (23.5%) were CR
- In the 8 patients who previously received the combination of venetoclax and azacitadine, a standard treatment for AML patients unfit for chemotherapy, 3 (37.5%) patients achieved a CR/CRh
- Time to CR/CRh was median 2.1 months and median duration of CR/CRh was over 18 months, as of the cut-off date
SOURCE: PRNewswire