Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death in the United States, with about 150,000 deaths annually. About 90% of cases of lung cancer are one of the three major forms of non-small cell lung cancer. The five year survival rate of lung cancer patients is about 17% although this is expected to improve dramatically with the introduction of checkpoint inhibitors treatments such as anti-PD1 therapies Opdivo® and Keytruda® that have demonstrated RECIST complete response rates in clinical trials of 10% - 25%. Nevertheless, for those non-responsive to checkpoint therapy – the vast majority of patients – there remains a dire need for effective treatments.
LuTK-01: Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer
LuTK-01 is a phase 1b dose escalation study to evaluate GMCI in subjects with high-risk, resectable NSCLC in combination with standard-of-care surgery. The study is being conducted at the Hospital of the University of Pennsylvania Hospital. The primary clinical end-point of LuTK01 is to evaluate the safety of GMCI when combined with standard surgery for NSCLC. In addition to clinical evaluation, immunological, genetic, and pathologic responses to therapy will also be evaluated to inform the design of follow-on, possible pivotal, clinical studies in NSCLC.
This study follows on promising results from a recent study, MpeTK01, using intrapleural administration of GMCI to treat malignant mesothelioma and metastatic lung cancer. In MpeTK01, also performed at the University of Pennsylvania, 4 of 19 patients had NSCLC metastatic to the pleural cavity. Expected survival of patients with this condition is generally less than 5 months, yet 3 of the 4 NSCLC patients had overall survival of more than 24 months from treatment. More information can be obtained about this study here (link).