The FDA has granted fast track designations to cavrotolimod (AST-008) for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma (MCC) that is refractory to previous PD-1 blockade and for use in combination with a PD-1/PD-L1 agent in those with advanced or metastatic cutaneous squamous cell carcinoma (CSCC) that is refractory to previous PD-1/PD-L1 blockade.

“There is an urgent need to investigate novel immunotherapeutic agents such as cavrotolimod that can be given to enhance the clinical efficacy of immunotherapy, particularly in patients with refractory solid tumors,” Adil Daud, MD, a clinical professor at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center and principal investigator in the phase 1b/2 trial of the agent, stated in a press release.

A spherical nucleic acid toll-like receptor 9 agonist, cavrotolimod was developed to activate the innate and adaptive immune systems to elicit strong antitumor responses in patients who receive it. In the phase 1b dose-escalation portion of the trial, investigators set out to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cavrotolimod both as a single agent and in combination with pembrolizumab (Keytruda) or cemiplimab-rwlc (Libtayo); one of the key objectives was to determine the recommended phase 2 dose (RP2D) for the drug.

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