On December 11, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported clinical data from its TakeAim Leukemia Study at the 2023 ASH (Free ASH Whitepaper) Conference (Press release, Curis, DEC 11, 2023, View Source [SID1234638414]).
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"We continue to be pleased with patient enrollment in the TakeAim Leukemia study and are especially pleased that the data confirm our observations to date – that emavusertib demonstrates a safe and manageable safety profile in addition to clear anti-cancer activity," said James Dentzer, President and Chief Executive Officer of Curis.
Data were presented for 92 patients treated with emavusertib monotherapy at doses ranging from 200 mg to 500 mg BID. Substantial reductions in blast counts were observed across all patient groups, irrespective of dose level, mutation status, or prior treatment history. Treatment-related adverse events (TRAEs) of grade ≥ 3 were found to be both manageable and acceptable, with no dose-limiting myelosuppression detected.
In the targeted population of patients with a FLT3 mutation, evidence of clear anti-cancer activity included changes in mutational profiles that suggest disease-modifying activity. These results were observed in patients including those who had progressed on a prior FLT3 inhibitor.
Among relapsed/refractory patients with FLT3 mutation who received ≤ 2 prior lines of treatment and had both baseline and post-treatment marrow evaluations, administering 300 mg emavusertib BID yielded compelling results. Notably, 2 out of 3 patients achieved a Complete Response (CR) with the other achieving morphological leukemia free state, indicating strong activity in patients with FLT3 mutation.
About emavusertib (CA-4948)
Emavusertib is a small molecule IRAK4 inhibitor. IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax.
About TakeAim Leukemia Study
TakeAim Leukemia Study (NCT04278768) – study is open for enrollment.