Moment Registry (MET NON SMALL CELL CANCER REGISTRY) for Advanced Non-Small Cell Lung Cancer (ANSCLC) Harboring MET Exon 14 (METEX14) Skipping
Author(s)
Thomas M1, Christopoulos P1, Iams WT2, Mazières J3, Cortot AB4, Peled N5, Minuti G6, Smit EF7, Ahrens S8, Berghoff K9, Eggleton SP10, Fries F11, Liu P12, Mahmoudpour H13, Menzel C14, O’Brate A15, Stroh C14, Oksen D16
1Thoraxklinik and National Center for Tumor Diseases at Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany, 2Division of Hematology/Oncology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA, 3CHU de Toulouse, Université Paul Sabatier, Toulouse, France, 4Université de Lille, CHU Lille, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 – UMR-S 1277 – Canther, F-59000 Lille, France, 5The Institute of Oncology, Shaare Zedek Medical Center, Jerusalem, Israel, 6Istituto Regina Elena – Istituti Fisioterapici Ospitalieri, Rome, Italy, 7Department of Pulmonary Diseases, Leiden University Medical Centre, Leiden, Netherlands, 8Biosample and Strategy Operations, Merck Healthcare KGaA, Darmstadt, Germany, 9Global Patient Safety, Merck Healthcare KGaA, Darmstadt, HE, Germany, 10Global Clinical Development, Merck Serono Ltd., Feltham, UK, an affiliate of Merck KGaA, Feltham, UK, 11Data Monitoring Management & Innovation, Merck Healthcare KGaA, Darmstadt, Germany, 12Global Development Operations, Merck Serono Pharmaceutical R&D Co., Ltd., Beijing, China, an affiliate of Merck KGaA, Beijing, China, 13Department of Epidemiology, Merck Healthcare KGaA, Darmstadt, HE, Germany, 14Companion Diagnostics & Biomarker Strategy, Merck Healthcare KGaA, Darmstadt, Germany, 15Global Medical Affairs, Merck Healthcare KGaA, Darmstadt, Germany, 16Department of Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany
Presentation Documents
OBJECTIVES:
METex14 skipping occurs in approximately 3% of NSCLC cases. MET inhibitors are investigated in open-label, single-arm trials in patients with METex14 skipping aNSCLC, such as the VISION trial investigating tepotinib. Since METex14 skipping is a rare and relatively new target in NSCLC, there is limited real-world data (RWD) and published evidence available to benchmark clinical trial results. MOMENT is a registry set up to collect data on patients with METex14 skipping aNSCLC. MOMENT data can be used to better understand characteristics and treatment outcomes of these rare patients and potentially to further benchmark clinical trial results.METHODS:
MOMENT is a multinational, non-interventional, prospective disease registry. Newly diagnosed patients and those already receiving treatment can enroll. Eligible systemic treatments include all anticancer therapies. MOMENT was designed using EMA guidelines to ensure high quality of data (consistency, completeness, accuracy, timeliness). Data elements are standardized (i.e. NCI-CTCAE and MedDRA) and a framework for quality management established (EMA/426390/2021 guideline). Patient biomarker status (e.g. PD-L1 status and comutational profile), patient characteristics, treatment information, treatment outcomes, and safety outcomes are collected. Imaging data are also collected to enable independent reads of tumor images. METex14 skipping status confirmation is arranged prior to enrollment if a locally used site assay is not yet internationally validated and if biopsy samples are available. MOMENT will enroll patients in over 60 sites worldwide (EU, UK, Israel, and North America). The first patient was enrolled on October 4, 2022, with ~700 patients expected to be enrolled until Q1 2027. When data collection is complete, data will be made available for external researchers.RESULTS:
N/ACONCLUSIONS:
MOMENT is designed to collect high-quality RWD from a rare patient population with METex14 skipping aNSCLC and enable further studies which can inform optimal care of these patients.Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
RWD121
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
Drugs, Oncology