AI-Powered Treatment Success: LP-300 Shows Promise for Non-Smoker Lung Cancer

The Phase 2 HARMONIC™ trial, leveraging the AI-assisted RADR® platform, demonstrates promising outcomes for LP-300 in treating non-smoker lung cancer patients, with an 86% clinical benefit rate. This novel therapy targets unique genetic mutations, offering new hope for a globally expanding patient demographic.

Lantern Pharma has announced promising results from its Phase 2 HARMONIC™ clinical trial of LP-300, an AI-assisted treatment for advanced non-small cell lung cancer (NSCLC) in never smokers. The preliminary data suggest that LP-300 is effective across various demographics and regardless of the metastatic disease sites. The trial is now expanding internationally, with the goal of securing a breakthrough therapy designation to fast-track FDA approval.

"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," said  Dr. Reggie Ewesuedo, Lantern VP of Clinical Development.

A Breakthrough in Lung Cancer Treatment

The HARMONIC™ trial, primarily aimed at patients with lung adenocarcinoma, has been designed to address the unique genetic profiles seen in non-smokers. These individuals often exhibit mutations that lead to resistance against standard tyrosine kinase inhibitor (TKI) treatments.

In the initial cohort of the Phase 2 study, seven patients with previously treated advanced NSCLC received the investigational small molecule LP-300 combined with pemetrexed and carboplatin. This treatment demonstrated a clinical benefit rate of 86%, with no additional safety concerns. The preliminary objective response rate was 43%, with three patients showing partial responses and an average tumor size reduction of 51%.

LP-300 was developed with Lantern’s AI platform, RADR®, which helped validate mechanisms and uncover insights for targeted patient populations. RADR® supports cancer therapy discovery and development, harnessing over 100 billion data points to advance Lantern’s portfolio and collaborative initiatives.

Global Impact and Regulatory Advances

The increasing proportion of never-smokers with NSCLC, especially in Asian countries like Japan and Taiwan where rates exceed 50%, underscores the urgent need for targeted treatment options.

The ongoing randomized phase of the study will further evaluate the efficacy of LP-300 in improving progression-free and overall survival rates. Lantern Pharma remains committed to advancing this potentially life-extending treatment, with hopes pinned on achieving breakthrough therapy designation for quicker FDA approval.

Safety profile of LP-300

“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,” said Dr. Janakiraman Subramanian, Director of Thoracic Oncology at Inova Schar Cancer Institute.

Preliminary results from the study's 7-patient lead-in showed predictable safety profiles consistent with the chemotherapy regimen alone. No patients experienced dose-limiting toxicities, and no discontinuations were observed due to treatment-related toxicity. The most common adverse events included decreases in white blood cell and platelet counts.

About Author: Mithat Can Turan

I am a software developer and a 4th-year Computer Engineering student at the Turkish-German University. I have worked on numerous software projects, especially those related to healthcare. My primary interests lie in digital health and AI applications within healthcare projects. I closely follow the latest developments in AI and digital health.