Lantern Pharma announced a remarkable clinical outcome in its Phase 2 HARMONIC trial, with a 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) achieving a durable complete response following treatment with LP-300 in combination with standard chemotherapy. The patient had previously failed three lines of therapy including Keytruda, radiation, and Tagrisso before enrolling in the study.
Exceptional Clinical Response in Challenging Case
The patient initially demonstrated a 57% tumor reduction and subsequently achieved full resolution of lung and adrenal lesions. Nearly two years after treatment initiation, the patient remains progression-free and has experienced no clinically significant adverse reactions across 21 cycles of treatment.
"The sustained response we're observing in this patient, particularly after three lines of prior standard of care treatments, is remarkable and provides strong support for LP-300's therapeutic potential," said Dr. Reggie Ewesuedo, Vice President of Clinical Development at Lantern Pharma. "The fact that this patient has tolerated 21 cycles of treatment without clinically significant adverse drug reactions and has achieved meaningful durable response reinforces our confidence in the promise of this drug-candidate in this patient population."
Addressing Critical Unmet Medical Need
This case represents a particularly significant observation given the patient's extensive treatment history with both immuno-oncology agents and targeted kinase therapies, highlighting the challenging nature of advanced NSCLC in non-responsive never-smokers. The never-smoker NSCLC population represents a significant and growing unmet medical need, with no therapies specifically approved for this patient subset.
Approximately 15-20% of all lung cancer patients in the U.S. are never-smokers, with significantly higher rates in Asian populations, where up to 50% of new lung cancer diagnoses occur in never-smokers. The sustained response over nearly two years, combined with excellent tolerability, underscores LP-300's potential to be a transformative treatment option for this underserved patient population.
HARMONIC Trial Design and Progress
The HARMONIC clinical trial is a Phase 2 study (NCT05456256) evaluating LP-300 in combination with standard chemotherapy (pemetrexed/carboplatin) for never-smokers with advanced lung adenocarcinoma who have experienced progression or intolerance to prior tyrosine kinase inhibitor (TKI) therapy. The trial is designed to assess whether LP-300, when added to chemotherapy, improves progression-free survival (PFS) and overall survival (OS) compared to the current standard-of-care chemotherapy doublet alone.
The multicenter, open-label, randomized study has planned enrollment of approximately 90 patients across sites in the United States, Japan, and Taiwan. The trial compares LP-300 in combination with standard-of-care chemotherapy versus chemotherapy alone in a 2:1 randomization, with co-primary endpoints of progression-free survival and overall survival.
AI-Driven Drug Development
LP-300 was advanced using Lantern's proprietary RADR AI platform to aid in the confirmation of combination synergies and the proposed mechanism of action. The lead-in cohort of the Phase 2 HARMONIC trial demonstrated an initial 86% clinical benefit rate and 43% objective response rate, leading to the current randomized expansion phase.
Lantern Pharma's RADR platform leverages over 200 billion oncology-focused data points and a library of 200+ advanced machine learning algorithms to help solve real-world problems in oncology drug development. On average, Lantern's newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $2.5 million per program.
Future Clinical Milestones
Lantern expects to continue reporting clinical updates from the HARMONIC trial throughout 2025 as enrollment progresses across multiple sites. The company anticipates providing an additional data update from the randomized expansion phase in the second half of 2025.
