Lantern Pharma Inc. has secured regulatory approval to expand its Harmonic trial, a Phase 2 clinical study evaluating LP-300 in non-small cell lung cancer (NSCLC) in never-smokers in both Japan and Taiwan.

Approximately one-third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never-smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research.

The approval to proceed with the Phase 2 clinical trials in Japan and Taiwan is expected to accelerate the collection of patient and response data needed for the next stage of evaluation and development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy.

Additionally, it may also bring a needed therapeutic option for LCINS diagnosed patients in Japan and Taiwan, where one-third of all lung cancer diagnoses are made among those who have never smoked. Finally, Lantern believes that this improves the positioning for drug candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus on serving the Asian markets.

LCINS are histologically, mutationally, and epidemiologically distinct from smoking-related lung cancers and occur almost exclusively as adenocarcinomas and most commonly in women and individuals of Asian ancestry. LCINS are highly enriched for alterations in the tyrosine kinase (TK) genes, have low tumor mutation burden (TMB) and low rates of PD-L1 expression.

Many of these factors may provide clarity on why LP-300 seems to have a distinct mechanism of action and anti-cancer activity in tumors among LCINS patients. Lantern believes that this unique mechanism of action and historically observed anti-tumor activity may ultimately prove to be a useful option for this growing class of patients globally.

Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, has been watching the development of LP-300 and the Harmonic™ trial in the United States with interest. Dr. Goto will now lead the trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States.

Dr. Goto stated, “LP-300 represents a promising new treatment option for never-smokers with advanced NSCLC harboring driver mutations like EGFR, ALK, ROS1, and MET, who have limited choices after progressing on targeted therapies. The Harmonic trial brings renewed hope to those facing this devastating disease, especially in East Asia, where EGFR mutations are highly prevalent. I am deeply gratified to contribute to the development of this innovative therapy that could potentially transform the treatment landscape for never-smokers battling advanced lung cancer."

The Harmonic trial (NCT05456256) is a Phase 2 clinical trial that is assessing the effect of Lantern’s investigational new drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced NSCLC.

The study has been designed as a 90-patient trial with approximately 2/3rds (60) of the patients receiving LP-300 with a chemotherapy doublet and the remaining 1/3rd (30) receiving the standard-of-care chemotherapy doublet alone.

In a previous multi-center Phase 3 clinical trial, a subset of never-smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91 percent and 125 percent, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. Additional information on the Harmonic trial can be found at the Harmonic clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic trial iPhone app, which is focused on education & awareness for never-smoker NSCLC patients and the NSCLC community.