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Lantern Pharma Announces Successful Outcome of FDA Type C Meeting Request for HARMONIC™ Phase 2 Trial of LP-300 in Never-Smokers with NSCLC
The FDA raised no objections to Lantern's key proposed protocol amendments to the HARMONIC™ clinical trial. Amendments include: (1) enriching enrollment for
About this update from Lantern Pharma Inc.
[{"type":"text","content":"\n\nThe FDA raised no objections to Lantern's key proposed protocol amendments to the HARMONIC™ clinical trial.\n\n\n\nAmendments include: (1) enriching enrollment for patients with EGFR exon 21 L858R mutations; (2) extending LP-300 dosing to a maximum of eight cycles; and (3) transitioning to a single-arm study design — changes that align with emerging data and support a clearer regulatory and partnering path.\n\n\n\nEGFR exon 21 L858R mutations account for approximately 40% of all EGFR-mutant NSCLC globally and up to 50% in Asian populations — a molecularly defined subset that consistently experiences inferior outcomes when treated with current EGFR-targeted therapies relative to patients with exon 19 deletions.\n\n\n\n DALLAS--(BUSINESS WIRE)--\nLantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, today 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.\n\n\nThe HARMONIC™ trial is designed to evaluate LP-300, a small molecule given in combination with carboplatin and pemetrexed, in never-smokers with advanced NSCLC adenocarcinoma who have experienced disease progression following treatment with kinase inhibitors. Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic features. Globally, approximately 400,000 to 500,000 patients are diagnosed with never-smoker NSCLC each year — a patient population that, if classified separately, would rank among the most common cancers worldwide. Despite this scale, no therapies have been specifically developed or labeled for the never-smoker NSCLC patient population, and the EGFR exon 21 L858R subset in particular continues to experience inferior outcomes when treated with currently available standards of care.\n\n\n“In our view, this successful Type C interaction with the FDA is a me...