Exicure Inc. (NASDAQ: XCUR) has provided an update regarding the Phase 1b/2 (AST-008) cavrotolimod study. The company is evaluating AST-008 in combination with LIBTAYO (cemiplimab) and KEYTRUDA (Pembrolizumab) in locally advanced or metastatic solid tumors in patients that are refractory to anti-PD-(L)1 therapy in two dose-expansion groups. One cohort is in cutaneous squamous cell carcinoma and another in MCC plus exploratory cohorts.
Exicure dose 26 patients in Phase 2 study
Preliminary data in the Phase 2 expansion study indicate that as of July 1, 2021, the company had doses 26 patients in the Phase 2 stage, and out of these, 17 were evaluable. Nine of the seventeen evaluable patients were part of the MCC group, and according to RECIST v1.1, the overall response reported was complete response in one patient and stable disease in another. the other eight patients were in the CSCC expansion cohort with registration and data accrual on-going or in the exploratory cohort. Treatment-related adverse events were either grade 1 or grade 2, and common symptoms included flu-like symptoms and injection site lesions.
Principal investigator in the cavrotomolid Phase 1b/2 study Sunandana Chandra said, “Merkel cell carcinoma is an aggressive skin cancer with a high probability of metastasis. Observing a patient with metastatic MCC who had been previously progressing on pembrolizumab monotherapy and radiation achieve a complete response is highly encouraging,
Cavrotolimod granted fast track designation
Cavrotolimod is an SNA made up of toll-like receptor nine agonists that are used in immuno-oncology. Exicure published initial findings from Phase 1b of the clinical study in December 2019, revealing possible indicators of anti-tumor activity in cancer patients when cavrotolimod was combined with pembrolizumab. Exicure began the Phase 2 stage of the clinical trial in the second quarter of 2020. Cavrotolimod was granted Fast Track and Orphan Drug designations in combination with anti-PD-1 therapy for locally advanced or metastatic MCC and metastatic CSCC resistant to anti-PD-(L)1 therapy.