Lantern Pharma Schedules FDA Meeting for May 2026

Lantern Pharma has scheduled a Type C meeting with the U.S. Food and Drug Administration for mid-May 2026 to seek feedback on proposed protocol amendments to its ongoing Phase 2 HARMONIC clinical trial evaluating LP-300. The amendments are grounded in emerging clinical data demonstrating a meaningful and consistent progression-free survival signal in patients with EGFR Exon 21 L858R-mutant non-small cell lung cancer who have progressed following any TKI-based treatment- a population carrying a particularly poor prognosis and limited remaining therapeutic options. Lantern is seeking the FDA's scientific guidance to sharpen the trial design around the patients most likely to benefit, and to pursue the most rigorous and efficient development path possible.Preliminary clinical data from the HARMONIC trial, with a data cutoff of April 13, 2026, have revealed a differentiated and consistent progression-free survival profile for LP-300 in patients harboring the EGFR Exon 21 L858R mutation - accounting for approximately 40% of all EGFR-mutant NSCLC cases globally, and a subgroup with a notably inferior prognosis following frontline TKI therapy compared with Exon 19 deletion patients. Among L858R patients in HARMONIC, those who completed 6 doses or cycles of LP-300 demonstrated a higher median PFS than the overall L858R cohort and those patients that had only 4 doses or cycles of LP-300. These outcomes were observed in patients who had already progressed on tyrosine kinase inhibitor therapy - a setting where prognosis is particularly challenging and where treatment tolerability is a critical consideration. The upper confidence interval for mPFS for the L858R patient group remains not calculable at the time of analysis, suggesting that a meaningful proportion of patients may be achieving disease control that extends substantially beyond the reported median. The Hazard Ratio observations to date for the L858R patient group are also encouraging.