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Azvudine + dosimertinib is a small molecule combination therapy being developed by Bio Genuine (Genuine Biotech) for the treatment of non-small cell lung cancer (NSCLC). Dosimertinib is a clinical-stage, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) designed to target EGFR mutations, including the T790M resistance mutation; preclinical data suggests it achieves higher concentrations in lung and brain tissues compared to osimertinib. Azvudine, originally developed as a nucleoside reverse transcriptase inhibitor for viral infections, acts in this oncology context as an immunomodulator that significantly reduces the levels of myeloid-derived suppressor cells (MDSCs) within the tumor microenvironment. By combining these two agents, the therapy aims to provide synergistic anti-tumor effects by simultaneously blocking oncogenic EGFR signaling and alleviating MDSC-mediated immunosuppression. Bio Genuine submitted an Investigational New Drug (IND) application for this combination to China's NMPA in November 2024.
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