#Spain #Glioblastoma #Laminar Pharma #LAM561 #Palma de Mallorca

Laminar Pharma Reaches Key Milestone in LAM561 Trial for Glioblastoma

In a significant achievement for cancer research, Laminar Pharma has announced the completion of the latest crucial step in their clinical trial for LAM561, a promising treatment for newly diagnosed glioblastoma patients. This achievement is marked by the 'last patient, last visit' (LPLV), culminating the active monitoring phase of the Phase 2b/3 trial titled 'LAM561 With RT and TMZ for Adults with Glioblastoma' (NCT04250922). The company anticipates sharing topline results from this groundbreaking trial in the second quarter of 2027.

Accordantly, the conclusion of the LPLV phase represents a pivotal progression in the trial, moving towards data lock and a critical overall survival (OS) analysis which will commence following the occurrence of 90 OS events. This development comes after the interim unblinded data was revealed in March 2025. At that time, the trial's Independent Data Monitoring Committee (IDMC) recommended that the study continue unblinded, leading to significant findings. Laminar Pharma reported a clinically relevant improvement in progression-free survival (PFS) among MGMT-methylated patients who received LAM561 in combination with the standard of care, relative to those in the placebo control group.

Demonstrating its commitment to patient welfare, Laminar Pharma has pledged to maintain treatment for those patients who derived clinical benefits throughout the trial, allowing them to continue with LAM561 through a compassionate use program until the drug is authorized for marketing.

Dr. Pablo Escribà, CEO of Laminar Pharma, expressed immense gratitude toward the participating patients, their families, and the healthcare professionals involved, emphasizing that reaching the LPLV is a major step toward delivering a crucial therapy for individuals battling one of the most aggressive forms of brain cancer. He stated, "Reaching the 'last patient, last visit' is a milestone for Laminar Pharma..."

The LAM561 Phase 2b/3 trial is meticulously structured as an international, multicenter, randomized, double-blind (until reaching the interim analysis), placebo-controlled study. It primarily aims to assess the efficacy and safety of LAM561, administered alongside radiotherapy and temozolomide, in patients recently diagnosed with IDH-wildtype glioblastoma. This trial comprises two randomized arms comprising LAM561 and standard of care (SoC) compared to a placebo plus SoC. The primary objectives are focused on overall survival rates while also tracking progression free survival using the Response Assessment in Neuro-Oncology (RANO) criteria.

Understanding Glioblastoma

Glioblastoma, or GBM, is the most prevalent primary malignant brain tumor, comprising nearly half of all gliomas and around 25% of all primary brain and central nervous system tumors. The current incidence rate of GBM across Europe surpasses 25,000 new cases annually, with global figures exceeding 100,000 per year. Unfortunately, the prognosis remains grim, with a median survival time approximately 14.5 months following optimized treatments, whereby only about 15% of patients survive two years, and a mere 4% achieve a five-year survival rate. This grim outlook accentuates the urgent necessity for innovative therapeutic alternatives that promise enhanced safety and efficacy.

About LAM561

LAM561, a synthetic derivative of oleic acid known scientifically as 2-hydroxyoleic acid, represents the most advanced drug in Laminar Pharma's pipeline, designed for oral administration. This therapy aims to alter the composition of cancer cells' plasma membranes, targeting membrane-associated signaling proteins that are instrumental in tumor progression. Existing preliminary clinical data indicate LAM561's potential effectiveness in treating aggressive brain tumors, including glioblastoma.

The Future of Laminar Pharma

Founded in 2006 and headquartered in Mallorca, Spain, Laminar Pharmaceuticals S.A. is committed to translational health research aimed at innovating drug designs for oncological and other health challenges. By utilizing Melitherapy—an approach that leverages synthetic fatty acids as first-in-class health solutions—the firm directs its efforts toward both molecule design and clinical trials. As Laminar progresses towards launching new therapies, constant investment in research and development is at the forefront of their strategy.

Overall, the conclusion of the active phase of the LAM561 trial stands as a promising advancement in the fight against glioblastoma, as Laminar Pharma continues to strive towards providing novel and effective treatments for patients still in need of hope in battling this formidable disease.