• Lantern Pharma Schedules Type C Meeting with the FDA to Advance HARMONIC™ Protocol Amendments Targeting This High-Need Population, Reflecting LP-300's Novel Mechanism of Action and the Rapidly Evolving Post-TKI Standard of Care
  • 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

Lantern Pharma Inc. (NASDAQ:LTRN), an AI-driven precision oncology company, today announced it has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) 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 (NSCLC) who have progressed following any TKI-based treatment (including osimertinib) — 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.

Emerging Clinical Evidence: A Consistent and Coherent Signal

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 (including osimertinib) therapy compared with Exon 19 deletion patients. Among the 16 L858R-mutant patients enrolled in HARMONIC™, LP-300 in combination with carboplatin and pemetrexed demonstrated:

 

8.3 mo

mPFS — L858R Patients

n=16 | 95% CI: 6.2–NC

 

86% / 43%

Clinical Benefit Rate / ORR

Safety Lead-In Cohort (US)

 

HR 0.37

L858R vs. Non-L858R

95% CI: 0.15–0.89

 

~$4B+

Annual Market Opportunity

L858R-enriched never-smoker NSCLC

These outcomes were observed in patients who had already progressed on tyrosine kinase inhibitor (TKI) therapy — a setting where prognosis is particularly challenging and where treatment tolerability is a critical consideration. The upper confidence interval for mPFS (median progression-free survival) 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 (HR) observations to date for the L858R patient group are also encouraging.

Independent Statistical Signal: Multivariable Analysis

To assess whether the emerging L858R efficacy signal might be explained by other patient characteristics, a multivariable Cox regression analysis was conducted incorporating race, gender, and TP53 mutation status. The L858R mutation remained a statistically significant independent predictor of progression-free survival across all models tested:

  • After adjusting for race and gender: HR 0.36 (95% CI: 0.15–0.90, p=0.028) — no significant associations were observed for race or gender alone
  • After incorporating TP53 mutation status: HR 0.23 (95% CI: 0.06–0.91, p=0.036) — L858R effect remained significant

These analyses are exploratory and based on a small patient cohort. Lantern plans to support these findings with additional data from the ongoing HARMONIC™ trial as enrollment and patient monitoring continues.