SGI-110: Phase I/II data
Top-line data from 67 evaluable AML patients who had a minimum follow up of 3 months in the Phase II portion of the open-label, U.S. Phase I/II SGI-110-01 trial showed that subcutaneous SGI-110 led to an overall remission rate, defined as complete remission or complete remission with incomplete hematologic recovery, of 25%. Specifically, SGI-110 led to 9 remissions in 17 treatment-naïve elderly AML patients who were not suitable for induction chemotherapy and 8 remissions in 50 relapsed/refractory AML patients. Astex said that no formal threshold has been established for meeting the endpoint, the primary for the Phase II portion of the trial. Detailed data have been submitted for presentation at the American Society of Hematology meeting in New Orleans in December.
In June, Astex reported interim data from 15 evaluable intermediate- and high-risk MDS patients who received prior azacitidine or decitabine therapy in the dose-escalation Phase I portion of the trial showing that SGI-110 led to an overall response rate (ORR) of 40% (see BioCentury, July 1). Last year, Astex reported data from 66 patients with MDS or AML in the Phase I portion showing that SGI-110 led to 2 complete responses and 1 partial response in patients with refractory AML and no prior resistance to hypomethylating agents (n=7) (see BioCentury, April 23, 2012). ...