Approval for Lantern Pharma's Expanded NSCLC Trial in Never-Smokers in Japan and Taiwan

Lantern Pharma, a company specializing in the development of cancer treatments using artificial intelligence (AI) and machine learning (ML), has recently been granted regulatory approval to expand its Phase 2 clinical study. The study, known as the Harmonic™ trial, is set to evaluate the drug LP-300 for non-small cell lung cancer (NSCLC) patients who have never smoked, in both Japan and Taiwan.

In East Asia, a significant and growing number of NSCLC patients have never smoked, with estimates suggesting that approximately 33% fall into this category. This patient population is distinct from those with smoking-related lung cancers, often presenting as adenocarcinomas and predominantly affecting women and individuals of Asian descent. These non-smoker lung cancer patients (LCINS) are characterized by specific alterations in tyrosine kinase (TK) genes, which are associated with a lower tumor mutation burden and PD-L1 expression levels.

The approval to conduct Phase 2 trials in Japan and Taiwan is anticipated to expedite the collection of essential patient data, which will be instrumental in the subsequent evaluation and development of LP-300. This therapeutic agent is intended for the treatment of relapsed and inoperable primary adenocarcinoma of the lung, in combination with chemotherapy. The potential availability of LP-300 as a treatment option for LCINS patients in these regions is particularly significant, given that a third of all lung cancer diagnoses are among never-smokers.

Lantern Pharma's belief is that the unique mechanism of action of LP-300 and its observed anti-tumor activity could provide a valuable treatment option for this expanding group of patients on a global scale. Dr. Yashushi Goto, a lung cancer expert from the National Cancer Center of Japan, has shown interest in the development of LP-300 and the Harmonic™ trial. He will now spearhead the trial in Japan, where the rate of NSCLC in never-smokers is notably higher than in the United States.

The Harmonic™ trial (NCT05456256) is designed to assess the impact of LP-300 in combination with standard chemotherapy on the survival rates of never-smoker patients with advanced NSCLC. The trial plans to enroll 90 patients, with the majority receiving LP-300 alongside chemotherapy, and a smaller group receiving chemotherapy alone. Prior results from a Phase 3 clinical trial have shown promising survival rates among never-smoker NSCLC patients who were treated with LP-300 combined with chemotherapy.

Lantern Pharma's AI and ML platform, RADR®, plays a crucial role in the company's mission to revolutionize oncology drug discovery and development. With access to over 60 billion oncology-focused data points and a library of advanced ML algorithms, Lantern Pharma is well-positioned to address significant challenges in the field of oncology drug development. The company's pipeline of innovative therapies, which includes both solid tumors and blood cancers, as well as an antibody-drug conjugate (ADC) program, holds the potential to serve a vast patient population and transform cancer treatment.