Lantern Pharma Expands Phase 2 Harmonic Clinical Trial to Japan and Taiwan

Lantern Pharma (NASDAQ: LTRN) has dosed the first patient in Japan as part of the expansion of its Phase 2 Harmonic clinical trial. The trial evaluates LP-300 in never-smokers with non-small cell lung cancer (NSCLC) who have relapsed after tyrosine kinase inhibitor (TKI) treatments. This expansion marks a significant step into Asia, where NSCLC among never-smokers is 2–3 times more prevalent than in Western countries.

The trial now includes ten sites across Japan and Taiwan, with additional locations expected soon. In Japan, the National Cancer Center, led by Dr. Yasushi Goto, is among the participating centers.

Key Facts About the Harmonic Trial

• Trial Design: Multicenter, open-label, randomized Phase 2 study of LP-300 with chemotherapy (pemetrexed/carboplatin) vs. chemotherapy alone.
• Endpoints: Progression-free survival (PFS) and overall survival (OS).
• Population: Never-smoker NSCLC patients, a subgroup representing 33–40% of lung cancer cases in Japan and over 50% in Taiwan.
• Enrollment Target: 90 patients across the U.S. and Asia.

Encouraging Early Results

Initial data from the U.S. safety lead-in cohort (August 2024) showed an 86% clinical benefit rate and 43% objective response rate among seven patients treated with LP-300. Tumor size reductions ranged from partial responses to stable disease, with no dose-limiting toxicities reported.

This data provided the foundation for the trial’s expansion to East Asia, a region with a high prevalence of NSCLC in never-smokers.

AI-Powered Drug Development

LP-300’s development is supported by Lantern Pharma’s AI platform, RADR, which integrates billions of oncology-specific data points. RADR identified LP-300’s potential to reverse chemotherapy resistance and benefit low-to-intermediate tumor mutation burden (TMB) patients, a group less responsive to immunotherapy.

LP-300 targets tyrosine kinase receptors and redox enzymes, enhancing chemotherapy outcomes in NSCLC.

Moving Forward

Panna Sharma, Lantern Pharma’s CEO, highlighted the trial’s significance:

“This expansion accelerates enrollment and addresses a critical need in a region heavily impacted by never-smoker NSCLC.”

Lantern Pharma aims to provide data to support regulatory filings, including potential Breakthrough Therapy designation, addressing the global need for targeted therapies in never-smoker NSCLC.

Cover photo: Mount Fuji, Honshu, Japan, photo by Mike Photo Corner

Topics: Clinical Trials