- Exicure Inc XCUR has reported interim results from Phase 1b/2 trial evaluating cavrotolimod (AST-008) in patients with advanced or metastatic solid tumors refractory to anti-PD-(L)1 therapy.
- The trial is assessing cavrotolimod in combination with Merck & Co Inc's MRK Keytruda (pembrolizumab) or Sanofi SA SNY - Regeneron Pharmaceuticals Inc's REGN Libtayo (cemiplimab) in two primary dose-expansion cohorts, one in Merkel cell carcinoma (MCC) and one in cutaneous squamous cell carcinoma (CSCC), and three exploratory cohorts.
- As of the data cutoff date of July 1, 26 patients were dosed, of whom 17 were evaluable.
- One MCC patient achieved Complete response (CR), and one MCC patient achieved stable disease.
- The 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.
- The majority (93%) of treatment-related adverse events (TRAEs) were mild or moderate. The most common TRAEs were injection-site reactions and flu-like symptoms.
- Two patients experienced serious adverse events assessed as related to cavrotolimod by clinical trial investigators.
- The confirmed overall response rate (ORR) in all evaluable MCC patients was 21% (three of 14), included two CRs and one partial response (PR).
- Cavrotolimod (AST-008) is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications.
- Price Action: XCUR shares are down 4.61% at $1.35 during the market session on the last check Thursday.
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