Lung cancer, traditionally linked to smoking, is increasingly affecting individuals who have never smoked. Recent studies indicate that 15% to 25% of lung cancer diagnoses occur in never-smokers, with certain populations experiencing even higher rates.
Lantern Pharma, a biotech company leveraging artificial intelligence (AI) to innovate cancer treatment and accelerate oncology drug discovery, has shared encouraging preliminary results from its ongoing Phase 2 HARMONIC™ clinical trial.
This study is investigating the efficacy of LP-300, an experimental drug candidate, in combination with pemetrexed and carboplatin for never-smokers with advanced non-small cell lung cancer (the most common type of lung cancer, accounting for about 85% of all lung cancer cases), that have progressed after tyrosine kinase inhibitor (TKI) therapy. LP-300’s development has been supported by Lantern’s AI platform, RADR®, which utilizes over 100 billion oncology-focused data points to inform drug discovery and targeted patient selection.
Initial Safety Lead-in Results
The safety lead-in portion of the trial enrolled seven patients, all of whom received LP-300 alongside pemetrexed and carboplatin. Early findings show a favorable safety profile, consistent with the chemotherapy regimen alone. There were no dose-limiting toxicities or treatment-related discontinuations. The most common side effects observed were reductions in white blood cell and platelet counts, typical for chemotherapy.
Preliminary Efficacy Insights
Of the seven patients:
- Clinical benefit rate (CBR) was 86%, with six patients showing positive clinical outcomes.
- Objective response rate (ORR) was 43%, with three patients achieving partial tumor responses and another three experiencing stable disease.
- Tumor size reductions among partial responders averaged 51%, including complete resolution of metastatic lesions in some cases. Stable disease patients exhibited an average tumor size reduction of 13%, with two showing significant decreases in distal lesion size.
One patient has remained in the study for 14 months, with a 57% reduction in tumor size and durable disease control. Additional data on progression-free survival (PFS) and response duration are pending as the trial continues.
Addressing Unmet Needs in Never-Smokers with NSCLC
Never-smokers with NSCLC often face limited treatment options after TKI failure, as they typically do not qualify for checkpoint inhibitor immunotherapies. The global rise in never-smoker NSCLC cases—33% in Japan and over 50% in Taiwan—highlights the need for alternative therapies. Lantern is addressing this gap through LP-300, which has demonstrated potential to enhance outcomes without compounding chemotherapy-related toxicities.
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Global Expansion and Future Plans
Lantern has initiated trial site activations in Japan and Taiwan, including the prestigious National Cancer Center in Tokyo. The randomized phase of the trial will expand enrollment to up to 80 patients, evaluating PFS and overall survival (OS) across two arms: one receiving LP-300 with chemotherapy and the other receiving chemotherapy alone. Interim results will be shared after 30 clinical events are recorded.
Innovation Through AI: RADR® and Beyond
Lantern Pharma’s RADR® platform represents a breakthrough in cancer drug development by leveraging artificial intelligence to analyze vast amounts of biological and clinical data. At its core, RADR® is designed to process and integrate diverse datasets, including genomic data (information about patients’ genetic makeup), transcriptomic data (gene expression levels), clinical data (patient health records and treatment outcomes), and drug sensitivity data (how different cancer cells respond to specific treatments). This integration of data creates a comprehensive and highly detailed resource that enables RADR® to uncover critical insights into the biology of cancer and how it responds to therapy.
The platform uses advanced machine learning algorithms to analyze patterns and relationships within this data. One of its key strengths is identifying biomarkers—specific genes or molecules that signal how a patient might respond to a particular drug. Additionally, RADR® reveals intricate drug-tumor interactions, providing insights into how specific drugs affect different cancer types. These findings are essential for developing therapies that are precisely targeted to the unique biology of individual patients, making treatments more effective and less prone to failure.
A standout feature of RADR® is its ability to build predictive models that anticipate patient responses to treatments. For instance, it can forecast which patients are most likely to benefit from a drug and identify those who may experience adverse side effects. These predictive capabilities are invaluable during the drug development process, as they allow researchers to select the right patients for clinical trials. This targeted approach enhances the likelihood of trial success and minimizes unnecessary risks for patients.
Another significant contribution of RADR® is its role in optimizing clinical trials. By using its advanced analytical capabilities, the platform helps stratify patients into groups based on their predicted responses to treatments. This stratification ensures that clinical trials are more efficient, focused, and likely to yield meaningful results. Additionally, RADR® assists in designing trials that are streamlined and cost-effective, ultimately accelerating the development of new cancer therapies and reducing the time it takes for them to reach patients.
Lantern’s RADR® platform played a critical role in validating LP-300’s mechanism and optimizing patient targeting. The company plans to explore additional combinations involving LP-300 and other approved agents for broader application in NSCLC and potentially earlier stages of treatment. A retrospective analysis of previous trials revealed significant survival benefits for never-smoker patients treated with LP-300 alongside cisplatin and paclitaxel, supporting its promise as a first-in-class therapy.
Future Milestones
Lantern aims to gather more robust clinical data from its U.S. and Asian trial sites to confirm the preliminary findings. Should the data continue to show significant benefits, the company may seek Breakthrough Therapy designation from the FDA, which could expedite LP-300’s path to regulatory approval. The estimated market opportunity for therapies addressing never-smoker NSCLC exceeds $2 billion annually.
About LP-300
LP-300 is a novel small-molecule drug candidate targeting tyrosine kinase receptors and redox pathways implicated in NSCLC, particularly among never-smokers. The drug has shown promise in modulating key pathways involved in cancer growth and progression, making it a potentially transformative option for this growing patient population.
About Lantern Pharma
Lantern Pharma combines cutting-edge AI and machine learning with oncology expertise to revolutionize cancer drug development. Its proprietary RADR® platform enables rapid identification and advancement of new therapies, significantly reducing development timelines and costs. Lantern’s pipeline includes multiple Phase 1 and Phase 2 programs targeting solid tumors and blood cancers, with a combined market potential of over $15 billion annually.
