On October 7, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, reported that it has received regulatory and IRB approvals in Taiwan to open the next stage (Part 2) of its Phase 2 HARMONIC trial of LP-300. The Taiwan Food and Drug Administration (TFDA) approved the amended protocol earlier in September, and the lead Taiwan site received local Institutional Review Board (IRB) approval on September 29, 2026. The lead site is now open to accrual and actively screening patients. The approval also allows additional Taiwan sites to proceed with their own IRB reviews. Lantern anticipates IRB approval in an additional two sites during Q4.
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In the United States, a central IRB has approved the amended protocol, and academic clinical sites have begun identifying patients whose tumors carry the EGFR exon 21 L858R mutation. Patients enrolled under the amended protocol will be eligible for up to eight cycles of LP-300, which is an increase from the prior limit of up to six cycles.
The increase to eight cycles is supported by two key findings:
Longer progression-free survival in patients completing more cycles – In the ongoing Phase 2 trial, L858R patients who completed six cycles of LP-300 had a median progression-free survival (mPFS) of 8.9 months (n=9; three had not yet progressed), compared with 8.3 months for all L858R patients (n=16). These data are exploratory and need to be confirmed in additional patients.
Comparable safety with longer treatment – In HARMONIC , the safety profile of patients who received six cycles was comparable to that of patients who received four. Additionally, in prior clinical trials with LP-300, up to eight cycles at the current dose did not alter LP-300’s safety profile.
Taiwan: High Patient Population & Need
Lung cancer has been the leading cause of cancer death in Taiwan for decades, and more than half of lung cancer patients there have never smoked.1,2 According to Taiwan’s 2025 national lung cancer treatment guidelines, 55% of Taiwanese patients with advanced lung adenocarcinoma harbor EGFR mutations, predominantly exon 19 deletions and exon 21 L858R substitutions.1
Taiwan’s health system is also set up to find these patients. National Health Insurance reimburses next-generation sequencing at the time of drug resistance, so patients progressing on EGFR-targeted therapy can be profiled at the point where they would become eligible for HARMONIC. Lantern plans to open additional sites in Taiwan and expects this combination of high mutation prevalence and available molecular testing to support efficient enrollment in Part 2.
East Asia: A Consistent Pattern of Patient Need
Approximately one third of lung cancer patients in East Asia are never-smokers (39.7% in China, 38% in South Korea and 32.8% in Japan),3 compared with approximately 15% of NSCLC diagnoses in the United States.4 EGFR mutations are present in roughly half of advanced lung adenocarcinomas in Asian patients.5 By comparison, a pooled analysis of 456 studies put EGFR mutation prevalence in NSCLC at approximately 14% in Europe and 24% in the United States.6 The L858R mutation is also more common in Asia: a worldwide meta-analysis found that L858R accounts for approximately 41% of EGFR mutations in Asian patients with advanced NSCLC, compared with approximately 30% in European patients.7 Among East Asian never-smokers with lung adenocarcinoma, EGFR mutations are the most common driver, found in 60 to 78% of cases.3
Lantern has now enrolled or opened HARMONIC in two East Asian regions, having completed targeted enrollment in Japan across five clinical centers in 2025. The Company believes that data generated in Taiwan and Japan will be relevant to the broader East Asian patient population and will support discussions regarding partnering and regional co-development of LP-300 with Asia-focused biopharma companies.
Part 2 Clinical Trial Design
Part 2 implements the protocol amendments to which the FDA had no objections and that were announced by Lantern in May 2026:
Enrollment is limited to patients with the EGFR exon 21 L858R mutation who have progressed after tyrosine kinase inhibitor treatment.
LP-300 may be given for up to eight cycles, increased from six, in combination with carboplatin and pemetrexed.
"Never-smoker lung cancer is most common in East Asia. In Taiwan, more than half of lung cancer occurs in never-smokers, and a meaningful share of those patients carry the L858R mutation, where outcomes on current targeted therapies have lagged those of other EGFR-mutant patients. What we see in Taiwan is what clinicians see across the region. With these approvals, the next stage of HARMONIC opens where the need is high and where we expect enrollment to be efficient. That matters for how quickly we can get to a clear answer on LP-300."
— Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc.
Rationale
Preliminary analyses from HARMONIC suggested that patients with L858R-mutant disease may derive greater benefit from the LP-300 combination than other EGFR-mutant subgroups, with a previously reported median progression-free survival of 8.3 months in this group (n=16).
The increase to eight cycles is supported by two findings. In the ongoing Phase 2 trial, L858R patients who completed six cycles of LP-300 had a median progression-free survival of 8.9 months (n=9; three had not yet progressed), with a safety profile comparable to that of patients who received four cycles. In addition, prior clinical experience showed that up to eight cycles at the current dose did not alter LP-300’s safety profile.
These data are preliminary, exploratory and based on small patient numbers. Lantern expects to gather additional supporting data in the next stage of the Harmonic clinical trial.
Market Opportunity and Regional Partnering Strategy
Lung cancer is the most commonly diagnosed cancer worldwide, with approximately 2.5 million new cases in 2022. China and Japan together accounted for approximately 1.2 million of those cases, nearly half of the global total.8
Approximately 350,000 new cases of EGFR-mutant NSCLC are diagnosed worldwide each year, and Lantern estimates that 90,000 to 100,000 of those patients carry the EGFR exon 21 L858R mutation. Lantern estimates that the treatment of never-smokers with NSCLC represents an annual market opportunity of $4 billion or more.
No therapy has been developed or labeled specifically for never-smoker NSCLC. Lantern is exploring regional licensing, partnering and co-development opportunities for LP-300 to accelerate its development and realize its commercial potential in the geographies where patient need is greatest.
About LP-300 and the HARMONIC Trial
LP-300 is an investigational small molecule being evaluated in Lantern Pharma’s Phase 2 HARMONIC trial in combination with carboplatin and pemetrexed in never-smokers with advanced NSCLC adenocarcinoma who have progressed following treatment with EGFR tyrosine kinase inhibitors. Part 2 of HARMONIC is a single-arm study enrolling patients with EGFR exon 21 L858R mutations, with LP-300 dosing of up to eight cycles. The trial is registered on ClinicalTrials.gov under identifier NCT05456256. LP-300 has not received FDA marketing approval for any indication. All clinical data referenced in this press release are preliminary.
(Press release, Lantern Pharma, OCT 7, 2026, View Source [SID1234673260])