EXCLUSIVE: FDA Clears Lantern Pharma's Planned Phase 1b/2 Trial of LP-184 In Treatment-Resistant Lung Cancer Patients

The U.S. Food and Drug Administration (FDA) on Monday cleared the amendment to Lantern Pharma Inc.’s LTRN Investigational New Drug (IND) application for the Phase 1b/2 trial of LP-184 in a genomically defined patient population of non-small cell lung cancer (NSCLC).

The biomarker-focused Phase 1b/2 trial is designed to target high-risk NSCLC subtypes by evaluating LP-184 in combination with Bristol-Myers Squibb & Co.’s BMY immune checkpoint inhibitors, Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with advanced NSCLC harboring KEAP1 and/or STK11 mutations and low PD-L1 expression.

Also Read: EXCLUSIVE: Lantern Advances Breast Cancer Drug Candidate With FDA Clearance For Early-Stage Trial

The study is designed to assess safety, preliminary efficacy, and biomarker correlations, potentially paving a path toward accelerated development.

Lantern Pharma expects to prepare an application for a Fast Track or Accelerated Approval Designation for this patient population based on data from the planned trial and ongoing analysis from existing models.

The company said the median overall survival for newly diagnosed, advanced NSCLC with KEAP1 and/or STK11 mutations treated with checkpoint inhibitors and chemotherapy is estimated to be 15 months, and this population presents an annual market opportunity of over $2 billion.

In December 2024, the FDA granted Fast Track Designation for LP-184 for Triple-Negative Breast Cancer (TNBC). This marked the second Fast Track Designation received for LP-184 in 2024, following its designation for Glioblastoma in October.

LP-184 has demonstrated significant preclinical efficacy in TNBC models, including those resistant to PARP inhibitors, and recent data shows promising synergy with checkpoint inhibitors in TNBC.

In November 2024, Lantern Pharma and its wholly-owned subsidiary Starlight Therapeutics announced the presentation of new preclinical data and Phase 1b trial design for LP-184 in glioblastoma.

Following the determination of the Maximum Tolerated Dose and/or Recommended Phase 2 Dose from the ongoing Phase 1a study, Starlight Therapeutics plans to initiate a Phase 1b trial evaluating LP-184/STAR-001 in two cohorts of recurrent GBM patients: one arm anticipates administration of STAR-001 as monotherapy and the other arm anticipates administration of STAR-001 in combination with spironolactone (200 mg daily).

The trial will assess safety, pharmacokinetics, and objective response using RANO 2.0 criteria. Additionally, the study will evaluate biomarkers, including PTGR1 expression, ERCC3 levels, and DNA damage markers, to help identify patients most likely to respond to treatment.

Price Action: LTRN stock traded lower by 3.02% to $3.86 premarket at the last check on Monday.

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