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Exicure Provides Interim Results from Ongoing Phase 1b/2 Clinical Trial of Cavrotolimod (AST-008)
Response rate threshold achieved to continue advancing patient enrollment in Phase 2 Merkel cell carcinoma (MCC) dose-expansion cohort Confirmed overall
About this update from Exicure, Inc.
[{"type":"text","content":"\n\nResponse rate threshold achieved to continue advancing patient enrollment in Phase 2 Merkel cell carcinoma (MCC) dose-expansion cohort\n\n\nConfirmed overall response rate (ORR) of 21% in all evaluable MCC patients enrolled in the Phase 1b/2 study\n\n\nMedian duration of four Phase 1b stage responders is 14 months with the longest response to date of 17 months\n\n\n CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nExicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, is providing an update on the Phase 1b/2 clinical trial of cavrotolimod (AST-008) (NCT03684785). The Phase 2 stage of the trial is evaluating cavrotolimod in combination with pembrolizumab (KEYTRUDA®) or cemiplimab (LIBTAYO®) in patients with locally advanced or metastatic solid tumors refractory to anti-PD-(L)1 therapy in two primary dose-expansion cohorts, one in MCC and one in cutaneous squamous cell carcinoma (CSCC), and three exploratory cohorts.\n\nInterim data highlights from the Phase 2 expansion stage\n\n\nAs of the data cut-off date of July 1, 2021, 26 patients, all with documented progression on anti-PD-(L)1 therapy, have been dosed in the Phase 2 stage, of whom 17 patients were evaluable.\n\n\nNine of the 17 evaluable patients were in the MCC cohort and, per RECIST v1.1, best overall response was a complete response (CR) in one MCC patient and stable disease in one MCC patient.\n\n\nInjected and non-injected tumor lesions completely resolved in the MCC patient with a CR, supporting systemic (abscopal) effects.\n\n\nThe CR in one MCC patient met the pre-specified Phase 2 stage threshold to continue advancing patient enrollment in the MCC dose-expansion cohort.\n\n\n\n\nThe remaining 8 evaluable patients were enrolled in either the CSCC dose-expansion cohort, in which enrollment and data accrual is continuing, or in the exploratory cohorts.\n\n\nThe majority (93%) of treatment-related adverse events (TRAEs) were grade 1 or grade 2. The most common TRAEs were injection-site reactions and flu-like symptoms.\n\n\nTwo patients experienced serious adverse events assessed as related to cavrotolimod by clinical trial investigators. Treatment-related hypotension and flu-like symptoms were reported in one melanoma patient and a treatment-related injection reaction was reported in...