DALLAS — October 7, 2026
Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, announced regulatory and institutional approvals in Taiwan to initiate Part 2 of its Phase 2 HARMONIC™ trial evaluating investigational LP-300 in never-smokers with advanced non-small cell lung cancer (NSCLC). The Taiwan Food and Drug Administration approved the amended protocol in September, followed by Institutional Review Board approval at the lead Taiwan clinical site on September 29, 2026. The site is now open for enrollment and screening, while additional Taiwan sites can begin their local ethics reviews.
Trial Focuses on EGFR L858R-Mutant Lung Cancer
Part 2 is a single-arm study enrolling never-smokers with EGFR exon 21 L858R-mutant NSCLC whose disease has progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Participants will receive LP-300 in combination with carboplatin and pemetrexed, with treatment extended to a maximum of eight cycles, compared with the previous limit of six. In the United States, a central IRB has also approved the amended protocol, and academic sites have begun identifying eligible patients. Lantern anticipates additional IRB approvals at two Taiwan sites during the fourth quarter of 2026.
Preliminary Findings Support Extended Dosing
Lantern cited exploratory findings from the ongoing HARMONIC trial to support the protocol amendment. Among patients with the L858R mutation who completed six cycles of LP-300, median progression-free survival was 8.9 months in nine patients, compared with 8.3 months among all 16 L858R patients evaluated. Three of the nine patients who completed six cycles had not yet experienced disease progression at the time of analysis. The company also reported comparable safety profiles among patients receiving four versus six cycles, while prior clinical studies indicated that up to eight cycles at the current dose did not alter the treatment’s safety profile. These findings are preliminary, involve small patient numbers and require confirmation in additional patients.
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Lantern Targets Asian Markets and Regional Partnerships
Lantern highlighted the potential relevance of LP-300 in East Asia, where EGFR mutations are more prevalent in lung adenocarcinoma than in Europe and the United States. The company cited an estimated EGFR mutation prevalence of 55% in advanced lung adenocarcinoma in Taiwan and noted that the L858R mutation is relatively common among Asian patients. Lantern previously completed targeted enrollment in Japan across five clinical centers in 2025 and is now expanding the HARMONIC program in Taiwan. The company expects to complete pivotal trial dosing by mid-2027, with topline results anticipated in mid-2028, and is exploring regional licensing, partnering and co-development opportunities for LP-300. The investigational therapy has not received FDA marketing approval.
Source::Lantern Pharma, press release
