Lantern Pharma has secured regulatory and Institutional Review Board (IRB) clearances in Taiwan to initiate Part 2 of its Phase II HARMONIC clinical trial of LP-300 in combination with carboplatin and pemetrexed in never-smokers with advanced non-small cell lung adenocarcinoma (NSCLC).
Following protocol authorisation from the Taiwan Food and Drug Administration (TFDA) earlier in September, the primary Taiwanese site received IRB approval on 29 September 2026 and began screening patients.
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Lantern expects two further Taiwanese sites to gain ethics approvals during the fourth quarter.
Under the amended protocol, eligible participants may receive up to eight cycles of LP-300, increased from the previous limit of six cycles.
In the US, academic centres have started identifying patients whose tumours carry the epidermal growth factor receptor (EGFR) exon 21 L858R mutation after a central IRB authorised the amendments, to which the US FDA raised no objections in May 2026.
The single-arm stage enrols individuals whose disease progressed following tyrosine kinase inhibitor treatment.
The dosing adjustment follows exploratory Phase II findings demonstrating that L858R-mutant patients who completed six cycles achieved a median progression-free survival of 8.9 months, with three of nine participants not yet progressing.
By comparison, median progression-free survival stood at 8.3 months across all 16 L858R patients.
The safety profile among individuals receiving six cycles remained comparable to those receiving four cycles.
Lantern Pharma president and CEO Panna Sharma said: “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 enrolment to be efficient. That matters for how quickly we can get to a clear answer on LP-300.”
Lantern completed targeted enrolment across five centres in Japan during 2025 and plans to leverage regional data to discuss potential partnerships with Asian biopharmaceutical firms.
Alongside LP-300, the company’s pipeline includes LP-184 and LP-284.
