On March 6, 2024 Laminar Pharmaceuticals S.A., a clinical-stage biotechnological company developing novel therapies to treat diverse pathologies with unmet clinical needs, reported that the Independent Data Monitoring Committee (IDMC) after evaluating the interim clinical results of the CLINGLIO clinical trial, has recommended that the trial should "continue without modifications" (Press release, Laminar Pharma, MAR 6, 2024, View Source [SID1234640861]). The CLINGLIO study is a multinational, phase 2b/3, randomized, double-blind clinical trial evaluating LAM561 in combination with standard-of-care (SoC; combined tumour resection and chemoradiotherapy) for newly diagnosed glioblastoma (GBM) patients. The CLINGLIO trial, funded by a European Commission Grant (H2020) is being carried out in 21 hospitals in Spain, Italy, France, and UK. The investigational study drug, LAM561 (idroxioleic acid, sodium; 2-OHOA) is a synthetic fatty acid with a novel therapeutic approach, administrated orally to treat this devastating type of cancer.
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As part of the pre-specified plan, the experts from the IDMC committee at their meeting on February 23 recommended, based upon their evaluation of the unblinded medical and clinical statistical data from 103 patients, that the CLINGLIO trial should continue without modification. This interim analysis was conducted following the committee’s assessment of the efficacy – survival without progression (tumor growth or clinical deterioration) – of LAM561 after 45 progression events have occurred. This recommendation was eagerly awaited by Laminar as it ensures that the trial remains on track to have its first open readout at 66 progressions, expected in the Summer of 2024. Moreover, this interim recommendation by the IDMC confirms that with the current level of evidence, futility (lack of clinical benefit of the drug) has not been identified and continuance of the study is recommended.
"The positive IDMC interim review of LAM561 efficacy in newly diagnosed GBM represents a leap forward for our most advanced development. This is the first time that the efficacy of LAM561 has been assessed against placebo, a huge milestone in the project, and this recommendation was the best possible outcome at this stage" said Dr Pablo Escribá, Chief Executive Officer of Laminar Pharmaceuticals. "With the IDMC’s recommendation, we will continue to advance the CLINGLIO study to confirm the potential of LAM561 to improve the prognosis and quality of life in first-line glioblastoma patients treated with standard-of-care."
From Laminar’s point of view, this positive and expected recommendation follows the encouraging results from previous IDMC meeting, focused on safety, held in September 2023, in which no concerns were raised based on evaluation of the available safety data. Subsequent ongoing follow-up and monitoring of medical and pharmacovigilance data have not raised any further safety concerns to the medical team and study monitor nor the trial’s Ethics Board. Oral LAM561 has been well tolerated and indicates a safety profile consistent with prior clinical trials.
"A leap forward, and also the beginning of the last step to potentially reach clinical practice, as the next planned interim analysis will provide the unblinded clinical benefit/risk ratio data needed for the request for Conditional Market Authorization." – added Dr Adrian G. McNicholl, Laminar’s Chief of Clinical Operations. "However, even though we are hopeful with the advancement of the LAM561 clinical program, we must be careful not to raise patient’s expectations, as this is an investigational medicinal product, and we need to wait until the outcome of the next interim analysis has been re-evaluated by the IDMC and has been assessed by the regulatory agencies with whom we are already in direct contact".
As a designated orphan medicinal product in the EU, the study protocol, scientific validity, methodology, analyses and endpoints have been discussed in detail with the EMA during successive requests for Protocol Assistance. The CLINGLIO trial is considered pivotal in that results showing significant clinical benefit could be sufficient for a request for conditional marketing authorization in the EU late this year; and potential full marketing authorization in 2025, for which enabling pre-submission interactions with the EMA have been initiated.