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ESMO 2021 | CV8102 alone or in combination with anti-PD-1 antibodies for patients with skin cancer

Thomas Eigentler, MD, University of Tübingen, Tübingen, Germany, shares the preliminary results from a dose-escalation Phase I trial (NCT03291002) investigating the efficacy and safety of CV8102, a non-coding, non-capped RNA that activates the innate and adaptive immunity via TLR7 and RIG-I, alone or in combination with anti-PD-1 antibodies in patients with advanced cutaneous melanoma (cMEL), cutaneous squamous cell carcinoma (cSCC), head and neck squamous cell carcinoma (hnSCC) or adenoid cystic carcinoma (ACC). Patients received doses ranging from 25 µg and 900 µg and the maximum tolerated dose was 600 µg. CV8102 demonstrated promising clinical efficacy in patients receiving both monotherapy and combination therapy. Overall, CV8102 showed an acceptable safety profile, with pyrexia and fatigue being the main adverse effects. Cytokine release syndrome (CRS), grade 3 elevation of liver enzymes, hypotension, and hypertension were also observed in both treatment arms. This interview took place at the European Society for Medical Oncology (ESMO) 2021 congress.