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Exicure Presents Positive Clinical Data with Cavrotolimod at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting
- Confirmed overall response rate (ORR) of 21% in the Phase 1b dose-escalation stage across all doses, with 1 complete response and 3 partial responses -
About this update from Exicure, Inc.
[{"type":"text","content":"\n- Confirmed overall response rate (ORR) of 21% in the Phase 1b dose-escalation stage across all doses, with 1 complete response and 3 partial responses\n\n- Confirmed ORR 33% at the highest and recommended Phase 2 dose\n\n- Durable and ongoing responses at the time of data analysis, with progression-free survival exceeding 6 months in all 4 responders and 16 months in 2 responders\n\n- Shrinkage of injected as well as regional or distant noninjected tumors, supportive of systemic (abscopal) effects\n\n CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nExicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing proprietary spherical nucleic acid (SNA™) technology, today announced the presentation of updated Phase 1b data from the ongoing Phase 1b/2 clinical trial evaluating intratumoral cavrotolimod (AST-008), the Company’s SNA-enabled TLR9 agonist, in combination with the anti-PD-1 therapies pembrolizumab (KEYTRUDA®) or cemiplimab (LIBTAYO®), in patients with Merkel cell carcinoma, cutaneous squamous cell carcinoma, and other advanced solid tumors (NCT03684785).\n\nThe Phase 1b dose-escalation stage was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of cavrotolimod alone and in combination with pembrolizumab, and to identify a recommended Phase 2 dose. Cavrotolimod was dosed intratumorally once weekly for 8 weeks and subsequently once every 3 weeks. Following an initial cavrotolimod monotherapy period, pembrolizumab was initiated at week 3 and dosed in combination with cavrotolimod once every 3 weeks. The Phase 1b stage enrolled patients with locally advanced or metastatic melanoma (n=10), Merkel cell carcinoma (n=5), cutaneous squamous cell carcinoma (n=2), head and neck squamous cell carcinoma (n=2), and leiomyosarcoma (n=1).\n\nUpdated data from the Phase 1b stage demonstrated that the combination of cavrotolimod and pembrolizumab continued to be well tolerated, with a confirmed overall response rate (ORR) of 21% (4/19 patients) according to RECIST v1.1 criteria. The combination immunotherapy regimen induced durable and systemic anti-tumor responses in patients with advanced solid tumors who previously progressed on anti-PD-1 therapy. At the time of enrollment in the clinical trial, 85% of patients were experiencing progressive disease despite treatmen...