Lantern Pharma has initiated the Taiwan arm of its Phase 2 HARMONIC trial, marking the first time the study has expanded into Asia. The trial is evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after treatment with tyrosine kinase inhibitors (TKIs). This expansion is particularly important given the high proportion of never-smoker lung cancer cases in Taiwan.
The first patient in Taiwan has been enrolled and dosed in the HARMONIC trial (NCT03786692), which is already dosing patients in the US and has plans to enroll patients in Japan. According to research published in the Journal of Thoracic Oncology, over half (53%) of new lung cancer cases in Taiwan occur in individuals who have never smoked.
Significance of Taiwan Expansion
Panna Sharma, President and CEO of Lantern Pharma, emphasized the importance of this expansion, stating, "The enrollment of our first patient in Taiwan marks another important milestone in the expansion of our HARMONIC trial. The extremely high proportion of never-smoker lung cancer patients in Taiwan makes this region important for accelerating our enrollment with the objective of addressing a critical unmet need in a population where this disease has an outsized impact."
Preliminary Trial Results
The Taiwan initiation follows encouraging preliminary results from the trial’s initial safety lead-in cohort. These results demonstrated an 86% clinical benefit rate and a 43% objective response rate among the first seven patients. The HARMONIC trial is examining LP-300 in combination with carboplatin and pemetrexed.
In the lead-in cohort of seven patients, six experienced clinical benefits from the combination of LP-300 alongside chemotherapy, while one patient experienced progressive disease. Among those who saw medical benefit, three showed partial responses with an average tumor size reduction of 51%, and three others saw disease stability with an average tumor size reduction of 13%.
LP-300 and RADR AI Platform
LP-300, designed using Lantern Pharma’s proprietary AI-driven platform, RADR, is an investigational new drug candidate for NSCLC patients who have never smoked and whose cancer has progressed despite TKI treatment. It is designed as a disulfide small molecule.
Clinical Development Strategy
Reggie Ewesuedo, vice president of clinical development at Lantern Pharma, noted, "The initiation of patient dosing in Taiwan demonstrates the continued momentum of our Asia expansion strategy. With active screening now occurring at multiple sites across both Japan and Taiwan, we expect to see accelerated enrollment in the trial. The enthusiasm we’ve seen from clinical collaborators in Taiwan reflects the significant need for new therapeutic options for never-smoker NSCLC patients in this region."
Trial Design and Endpoints
The Phase 2 HARMONIC trial is actively screening patients in multiple cancer centers in the US, Japan, and Taiwan. It is expected to enroll up to 90 patients across two treatment arms. The randomized trial (2:1 ratio) will compare the co-primary endpoints of progression-free survival (PFS) and overall survival (OS) between the LP-300 arm (LP-300 in combination with chemotherapy) and the standard of care (SOC) arm (chemotherapy alone).
