FDA Grants Fast Track Designation to Quaratusugene Ozeplasmid Immunogene Therapy Plus Pembrolizumab for NSCLC

On January 5, 2022 Genprex reported that The FDA granted fast track designation to quaratusugene ozeplasmid (Reqorsa), an immunogene therapy, in combination with pembrolizumab (Keytruda) as a potential treatment for patients with histologically confirmed, unresectable stage III or IV non–small cell lung cancer (NSCLC) who progressed after treatment with pembrolizumab (Press release, Genprex, JAN 5, 2022, View Source [SID1234607479])

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Data that were previously presented have shown a strong synergy between quaratusugene ozeplasmid and pembrolizumab in patients with NSCLC compared with pembrolizumab alone. The data highlighted a survival benefit, as well as an increase in natural killer cells and a decrease in PD-L1 expression on tumor cells following treatment with the immunogene therapy in a population of mice with a humanized immune system and metastatic lung cancers.