Curis Inc (NASDAQ: CRIS) has announced updated data from its ongoing Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
Key findings were presented at the European Hematology Association 2021 Virtual Congress and included data from 22 patients (11 with high-risk MDS, 11 with AML).
The primary objective was to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for CA-4948.
The company has found 300mg twice daily as the recommended Phase 2 dose in AML and high-risk MDS after observing no dose-limiting toxicities (DLT).
Out of 17 evaluable patients at the April 30 cutoff, five objective responses were observed, including one complete response (CR), one complete remission with incomplete hematologic recovery (Cri) & negative minimal residual disease, one partial response (PR), and two marrow CRs.
As reported earlier, 4 DLTs were observed in patients dosed higher than the Recommended Phase 2 Dose.
In the 400mg group, two patients experienced severe rhabdomyolysis.
In the 500mg arm, one patient experienced severe rhabdomyolysis and one syncope.
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