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Lantern Pharma has announced that the first patient in its Phase II HARMONIC clinical trial has been enrolled and dosed in Taiwan. The study is evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).1
According to Lantern Pharma, the location of Taiwan is significant as more than half of all new lung cancer diagnoses in the country occur in people who are classified as never-smokers. The company received regulatory approval to expand the HARMONIC study into Taiwan and Japan earlier in April.2
The HARMONIC trial is also ongoing in the US and is expected to enroll up to 90 patients across two treatment arms throughout its locations. The LP-300 arm will be evaluating the investigational therapy in combination with chemotherapy while patients in the second arm will receive standard of care with chemotherapy. The primary endpoints for the trial are PFS (progression free survival) and OS (median overall survival).
In a press release, Panna Sharma, president and CEO of Lantern Pharma said, “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.”
Reggie Ewesuedo, MD, MBA, VP of clinical development, Lantern Pharma added, “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.”
In August, Lantern Pharma shared preliminary results from the lead-in cohort of HARMONIC. Of the 7 patients in the cohort, 6 experienced clinical benefit from the LP-300-chemotherapy combination. Diving deeper into the data, 3 patients showed partial responses with an average tumor size reduction of 51% and 3 patients stabilized with an average tumor size reduction of 13%. No dose limiting toxicities or treatment-related serious adverse events were observed.3
In an earlier press release, Janakiraman Subramanian, MD, director of thoracic oncology at Inova Schar Cancer Institute said, “Preliminary results indicate that this LP-300 triplet regimen is active against advanced NSCLC with actionable alterations and there were no unexpected adverse events. Also, the early HARMONIC patient data indicates that the adverse events appear to be primarily due to chemotherapy and not the study drug.”
Ewesuedo added, “These initial results from the HARMONIC trial provide preliminary clinical evidence of both the safety and the mode of action for LP-300 in never-smokers with NSCLC. To see such a high clinical benefit rate, which is part of our secondary endpoints, this early in the trial is a motivating factor for accelerating our enrollment globally.”
References
1. Lantern Pharma Announces First Patient Enrolled in Taiwan for Phase 2 HARMONIC™ Clinical Trial of LP-300 in Never-Smoker NSCLC Patients. News release. Lantern Pharma. December 9, 2024. Accessed December 9, 2024. https://www.businesswire.com/news/home/20241209442575/en/Lantern-Pharma-Announces-First-Patient-Enrolled-in-Taiwan-for-Phase-2-HARMONIC%E2%84%A2-Clinical-Trial-of-LP-300-in-Never-Smoker-NSCLC-Patients
2. Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan. News release. Lantern Pharma. April 22, 2024. Accessed December 9, 2024. https://ir.lanternpharma.com/news-events/press-releases/detail/151/lantern-pharma-receives-regulatory-approval-to-expand
3. Lantern Pharma Announces Positive Clinical Update from Ongoing Phase 2 HARMONIC™ Clinical Trial for Never Smokers with Advanced NSCLC, Including an 86% Clinical Benefit Rate in the Initial Patient Cohort. News release. Lantern Pharma. August 5, 2024. Accessed December 9, 2024. https://www.businesswire.com/news/home/20240805396240/en/