Lantern Pharma Receives Regulatory Approval to Expand Harmonic Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan - Seite 2

Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, has been watching the development of LP-300 and the Harmonic trial in the United States with interest. Dr. Goto will now lead the trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States. Dr. Goto stated, “LP-300 represents a promising new treatment option for never-smokers with advanced NSCLC harboring driver mutations like EGFR, ALK, ROS1, and MET, who have limited choices after progressing on targeted therapies. The Harmonic trial brings renewed hope to those facing this devastating disease, especially in East Asia, where EGFR mutations are highly prevalent. I am deeply gratified to contribute to the development of this innovative therapy that could potentially transform the treatment landscape for never-smokers battling advanced lung cancer."

The Harmonic trial (NCT05456256) is a Phase 2 clinical trial that is assessing the effect of Lantern’s investigational new drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced NSCLC. The study has been designed as a 90 patient trial with approximately 2/3^rds (60) of the patients receiving LP-300 with a chemotherapy doublet and the remaining 1/3^rd (30) receiving the standard of care chemotherapy doublet alone. In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. Additional information on the Harmonic trial can be found at the Harmonic clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic trial iPhone app, which is focused on education & awareness for never smoker NSCLC patients and the NSCLC community.

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References:

1. Zhou F, Zhou C. Lung cancer in never smokers-the East Asian experience. Transl Lung Cancer Res. 2018 Aug;7(4):450-463. https://doi.org/10.21037/tlcr.2018.05.14. PMID: 30225210; PMCID: PMC6131183
2. LoPiccolo, J., Gusev, A., Christiani, D.C. et al. Lung cancer in patients who have never smoked — an emerging disease. Nat Rev Clin Oncol 21, 121–146 (2024). https://doi.org/10.1038/s41571-023-00844-0

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