Lantern Pharma Receives Positive FDA Response for LP-300 Trial

Lantern Pharma announced that it has received a successful response to its recent Type C meeting request from the U.S. Food and Drug Administration, FDA, focused on the ongoing Phase 2 Harmonic trial of LP-300 in never-smokers with advanced non-small cell lung cancer, NSCLC, adenocarcinoma. In its written responses to Lantern's Type C meeting request, the FDA raised no objections to key proposed protocol amendments, providing a more focused, clearer regulatory path forward for the Harmonic trial and for the future development of LP-300 in this distinct, high-need patient population. "In our view, this successful Type C interaction with the FDA is a meaningful de-risking milestone for the LP-300 program and for the Harmonic trial. The FDA's response to our proposed amendments supports our strategy to focus Harmonic on the EGFR exon 21 L858R-mutant never-smoker population, where emerging data suggest LP-300 may offer meaningful differentiated benefit when added to standard chemotherapy following TKI failure."