Benzinga | Jun 11, 2021 09:56AM EDT

Curis Shares Drop After Updated CA-4948 Data From Mid-Stage Blood Cancer Trial

* 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.

* Price Action: CRIS shares are down 31.7% at $8.65 during the market session on the last check Friday.