FDA Approves Phase II Clinical Trial of Avitinib for Moderate to Severe COVID-19 in Hospitalized Patients

2020Year7Month20Day，United StatesFDAOfficially Approved AivitinibINDApplication for Approval to Initiate Aivitinib in Patients withCOVID-19A Phase II, Double-Blind, Randomized Controlled Trial Evaluating the Efficacy and Safety Compared with Standard of Care in Patients with Moderate to Severe Pneumonia Caused by Viral Infection.

Avitinib is a selective inhibitor targeting mutantEGFR（EGFRm) andBTKsmall-molecule tyrosine kinase inhibitors (TKI), via irreversible bindingEGFRmReceptors includeT790MDrug-resistant receptors, enabling precision therapy forEGFRmnon-small cell lung cancer and viaEGFR TKITreatment failure andT790MNon-small cell lung cancer with drug-resistant mutations.

This study primarily focuses on the ability of avitinib to irreversibly bind to the BTK receptor, thereby inhibiting receptor phosphorylation. It is expected to exert immunomodulatory activity by suppressing the production of key inflammation-related cytokines (IL-1β, IL-6, and TNF-α), which are associated with disease progression in coronavirus disease (COVID-19) and poor prognosis in patients with acute respiratory distress syndrome (ARDS). Evidence suggests that dysregulated BTK-dependent signaling in pulmonary macrophages mediates this cytokine storm and plays a role in COVID-19 pneumonia.

Aivitinib has accumulated clinical study data from over 600 cancer patients across various tumor indications, including a registration-enabling study in non-small cell lung cancer (NSCLC). Most drug-related adverse events (AEs) were Grade 1 or 2, primarily consisting of elevated liver transaminases and diarrhea, which are common AEs associated with tyrosine kinase inhibitors (TKIs). Other common drug-related AEs included anemia, neutropenia, and thrombocytopenia, all of which are frequently observed with long-term TKI use. No unexpected AEs have been reported.

The approval of this clinical study signifies that Aivitinib will expand into new therapeutic areas. This research holds significant social importance, particularly given the ongoing challenges in controlling the COVID-19 pandemic abroad and the current shortage of therapeutic agents. Furthermore, Eisai will continue to conduct research on the first- and second-line treatment of non-small cell lung cancer (NSCLC) and targeted therapy for B-cell lymphoma, thereby promoting the clinical application of Aivitinib in oncology, immunology, and other fields.