Laminar Pharma Releases First Progression-Free Survival Data for LAM561 in Newly Diagnosed Glioblastoma Therapy

In a significant development for brain cancer treatment, Laminar Pharma, based in Palma de Mallorca, Spain, has released promising interim results from its clinical trial exploring the efficacy of LAM561, a novel therapy for newly diagnosed glioblastoma (ndGBM). Glioblastoma, notorious for its aggressive nature, has had limited advancements in treatment over the past two decades. This study, supported partly by the EU's H2020 Grant under the ClinGlio project, investigates whether the inclusion of LAM561 with standard chemoradiotherapy can enhance progression-free survival (PFS) in patients.

The trial, a pivotal phase 2b/3 study, involved 144 glioblastoma patients and is officially titled "A randomized, double-blind, placebo-controlled adjuvant trial..." (NCT04250922). In November 2024, an independent data monitoring committee (IDMC) recommended the trial's continuation until 90 overall survival (OS) events are reached, projected for late 2026. Furthermore, the study was unblinded, allowing participants to know whether they received LAM561 or a placebo.

Despite the primary interim outcome of a Hazard Ratio of 0.5 for PFS not being achieved across the entire trial population, subsequent stratified analysis revealed encouraging trends. Evaluations based on the methylation status of the MGMT promoter and RTOG scores, which gauge the severity of radiation therapy side effects, showed that MGMT-methylated patients experienced improved median PFS with LAM561. Specifically, patients with an RTOG score of 3 demonstrated a median PFS of 56.7 weeks with LAM561 versus 19 weeks with the placebo. For those with an RTOG score of 4, the median PFS was 86.4 weeks versus 54.7 weeks with placebo.

While these figures suggest a potentially significant clinical benefit for MGMT-methylated patients, the trial remains ongoing, and the final conclusions await the completion of the study and the final analysis. The importance of MGMT promoter methylation status is underscored by its known role in the prognosis of glioblastoma, with such methylation present in 35-50% of cases.

Dr. Pablo Escribà, CEO of Laminar Pharma, expressed optimism about the findings, stating that if these PFS improvements translate into OS benefits, LAM561 could represent a groundbreaking advancement in glioblastoma treatment. He emphasized the company's commitment to furthering this promising therapy's development.

The safety profile of LAM561, combined with the standard of care, was favorable, aligning with previous studies' findings and showing no new safety concerns. This points to LAM561's potential as a well-tolerated treatment option.

The trial's promising results build on earlier research indicating LAM561's potential to modify cancer cell membrane lipids, thereby disrupting pathways associated with tumor growth. As glioblastoma remains a challenging and often terminal diagnosis, innovative treatments like LAM561 offer hope for more effective therapeutic options.

Laminar Pharma, established in 2006, focuses on developing novel therapies based on Membrane Lipid Therapy. Headquartered in Mallorca with a branch in Massachusetts, the company is dedicated to advancing research in oncology and other medical fields through groundbreaking synthetic fatty acids.

As the study progresses, the scientific community and glioblastoma patients alike await the final data, which could redefine treatment paradigms for this formidable disease.