Laminar Pharma Announces "Last Patient, Last Visit" in LAM561 Phase 2b/3 Trial for Newly Diagnosed Glioblastoma Patients

Laminar Pharma, a leader in the development of innovative therapies based on a novel membrane lipid therapy approach, today announced that the last patient has completed their last visit (LPLV) in the company's Phase 2b/3 clinical trial of its lead asset, LAM561, in patients with newly diagnosed glioblastoma. This milestone marks the conclusion of the active clinical monitoring phase of the trial "LAM561 With RT and TMZ for Adults with Glioblastoma" (NCT04250922) which evaluates LAM561 in combination with standard of care (SoC). The company expects to report topline results from this study during the second quarter of 2027. Achieving LPLV represents a key operational step as the trial progresses through the data lock and the highly anticipated overall survival (OS) analysis, triggered once 90 OS events were reached. This development follows the interim unblinded data announced in March 2025, after the Independent Data Monitoring Committee (IDMC) recommendation in late 2024 for the study to be unblinded and continue without modification. At that time, Laminar Pharma reported a potential clinically relevant improvement in progression-free survival (PFS) for MGMT-methylated patients receiving LAM561 plus SoC compared to the placebo control group. Laminar Pharma's commitment to international ethical principles for post-trial access and continued patient care is demonstrated by the continuation of LAM561 treatment for patients who were experiencing clinical benefit according to their treating physicians, who prescribed continuing treatment beyond study completion through a compassionate use program that will be available for these patients until marketing authorization is granted. The safety profile observed throughout the trial remained consistent with prior studies, with the combination of LAM561 and SoC proving well-tolerated among the 144 enrolled patients. "Reaching the 'last patient, last visit' is a milestone for Laminar Pharma and brings us one step closer to our goal of delivering a much-needed therapy to patients battling one the most aggressive forms of brain cancer", said Dr. Pablo Escribà, CEO of Laminar Pharma. "We extend our deepest gratitude to the patients, their families, and the clinical investigators and healthcare personnel who have made this trial possible." Laminar's LAM561 Phase 2b/3 trial is an international, multicenter, randomized, double-blind (until interim analysis completion), placebo-controlled clinical trial designed to assess the efficacy and safety of LAM561 in combination with radiotherapy and temozolomide in patients with newly diagnosed, IDH-wildtype glioblastoma. The study consisted of two randomized (1:1) arms between LAM561+SoC and placebo+SoC. The primary efficacy endpoint will be overall survival, along with PFS using the Response Assessment in Neuro-Oncology (RANO) criteria. About Glioblastoma Glioblastoma (GBM) is the most common primary malignant brain tumor and accounts for nearly 50 percent of all gliomas and approximately 25 percent of all primary brain and CNS malignant tumors. The incidence of GBM in Europe is currently above 25,000 new cases each year, rising to over 100,000 cases per year worldwide. The prognosis for GBM patients is very poor, with a median survival time of about 14.5 months despite optimum chemo-radiation treatment. About 15% of patients survive two years after diagnosis and approximately 4% survive for five or more years. In this scenario, there is a desperate need for novel treatment alternatives that provide safe and more efficacious clinical outcomes. About LAM561 LAM561 (2-hydroxyoleic acid –2-OHOA, idroxioleic acid sodium) is a synthetic derivative of oleic acid and Laminar's most advanced product under development, which is taken orally. This drug regulates the composition of the plasma membrane in cancer cells, reducing the activity of membrane-associated signaling proteins that are known to promot...