Lantern Pharma has completed targeted enrolment for its multi-centre Phase II HARMONIC clinical trial of a disulfide small molecule, LP-300, in Japan for the treatment of non-small cell lung cancer (NSCLC).
The trial is intended specifically for never-smoker NSCLC subjects who have relapsed after tyrosine kinase inhibitor (TKI) treatment.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The open-label, randomised trial has enrolled ten subjects ahead of schedule at five sites, including the National Cancer Center Japan.
The trial is designed to assess the safety and efficacy of LP-300 in conjunction with standard-of-care chemotherapy (pemetrexed/carboplatin), against only chemotherapy.
It aims to enrol around 90 subjects across Japan, Taiwan, and the US, with overall survival (OS) and progression-free survival (PFS) as the primary endpoints.
Lantern Pharma CEO and president Panna Sharma said: “Completing our targeted enrolment in Japan ahead of schedule demonstrates excellent execution of our international expansion strategy and validates our decision to focus on regions where never-smoker NSCLC has the highest prevalence.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“This achievement builds momentum as we continue enrolment in Taiwan and the US, bringing us closer to generating the clinical data that could establish LP-300 as a treatment option for this underserved patient population with significant unmet medical need.”
LP-300 is an investigational drug candidate targeting TK receptors and cell redox enzymes, modulating cellular redox in main signalling pathways in NSCLC.
It has been assessed in various clinical trials, with retrospective analysis demonstrating a survival benefit in patients with never-smoker lung adenocarcinoma.
Previously, among the first seven subjects enrolled in the US, the HARMONIC trial showed positive outcomes in the initial safety lead-in cohort, demonstrating a 43% objective response rate and an 86% clinical benefit rate.
Additionally, recent data showed that one subject has attained a durable complete response in target cancer lesions with survival extending for about two years.
Further clinical and result data from the trial are expected later in this quarter, with updates on both the US and Asian subject cohorts.
In March 2024, Lantern dosed two subjects in a Phase Ia/Ib trial of LP-284 for relapsed or refractory non-Hodgkin’s lymphoma (NHL).
