دورية أكاديمية
Indirect comparison of capmatinib treatment from GEOMETRY mono-1 trial to SOC in German patients with locally advanced or metastatic NSCLC harboring METex14 skipping mutations.
| العنوان: | Indirect comparison of capmatinib treatment from GEOMETRY mono-1 trial to SOC in German patients with locally advanced or metastatic NSCLC harboring METex14 skipping mutations. |
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| المؤلفون: | Kron A; Lung Cancer Group Cologne, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany. Electronic address: anna.kron@uk-koeln.de., Scheffler M; Lung Cancer Group Cologne, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany., Wiesweg M; Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany., Hummel HD; Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken and Bavarian Cancer Research Center (BZKF), University Hospital Würzburg, Würzburg, Germany., Kulhavy J; Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken and Bavarian Cancer Research Center (BZKF), University Hospital Würzburg, Würzburg, Germany., Gatteloehner S; Department of Pathology, University Hospital Giessen and Marburg, Giessen, Germany., Kollmeier J; Department of Pneumology, Heckeshorn Lung Clinic, Helios Klinikum Emil von Behring, Berlin, Germany., Schubart C; Institute of Pathology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany., Groß T; Department of Medical Oncology and Pneumology (Internal Medicine VIII), Eberhard Karls University, Tübingen, Germany., Demes MC; Senckenberg Institute of Pathology, University Hospital Frankfurt, Frankfurt, Germany., Keymel S; Department of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, Düsseldorf, Germany., Joosten M; Institute of Pathology, Charité - Universitätsmedizin Berlin, Berlin, Germany., Merkelbach-Bruse S; Institute of Pathology, University Hospital and Medical Faculty, University of Cologne, Cologne, Germany., Wölwer CB; Institute of Pathology, University Hospital and Medical Faculty, University of Cologne, Cologne, Germany., Tufman A; Department of Medicine V, LMU University Hospital, LMU Munich, Comprehensive Pneumology Center, Member of the German Center for Lung Research (DZL), Munich, Germany., Kauffmann-Guerrero D; Department of Medicine V, LMU University Hospital, LMU Munich, Comprehensive Pneumology Center, Member of the German Center for Lung Research (DZL), Munich, Germany., Oeser K; Novartis Pharma GmbH, Nuernberg, Germany., Zehaczek M; Novartis Pharma GmbH, Nuernberg, Germany., Jeratsch U; Novartis Pharma GmbH, Nuernberg, Germany., Wolf J; Lung Cancer Group Cologne, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany. |
| المصدر: | European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2024 Aug; Vol. 207, pp. 114158. Date of Electronic Publication: 2024 Jun 14. |
| نوع المنشور: | Journal Article; Comparative Study; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Elsevier Science Ltd Original Publication: Oxford ; New York : Pergamon Press, c1990- |
| مواضيع طبية MeSH: | Carcinoma, Non-Small-Cell Lung*/drug therapy , Carcinoma, Non-Small-Cell Lung*/genetics , Carcinoma, Non-Small-Cell Lung*/pathology , Lung Neoplasms*/drug therapy , Lung Neoplasms*/genetics , Lung Neoplasms*/pathology , Mutation* , Benzamides*/therapeutic use , Proto-Oncogene Proteins c-met*/genetics , Proto-Oncogene Proteins c-met*/antagonists & inhibitors , Triazines*/therapeutic use , Triazines*/adverse effects, Humans ; Male ; Female ; Middle Aged ; Aged ; Germany ; Retrospective Studies ; Adult ; Aged, 80 and over ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/adverse effects ; Antineoplastic Agents/therapeutic use ; Antineoplastic Agents/adverse effects ; Imidazoles |
| مستخلص: | Background: This study provides comparative evidence of the selective MET inhibitor capmatinib versus standard of care (SOC) in first-line (1 L) and second-line (2 L) non-small cell lung cancer (NSCLC) patients with METex14 mutations in German routine care. Methods: SOC data were collected from German routine care via retrospective chart review. Analyses were conducted as naive and propensity score adjusted (PSA) comparisons to capmatinib-treated patients within the GEOMETRY mono-1 trial. Effectiveness endpoints included overall survival (OS), progression-free survival (PFS), overall response rate (ORR), time to CNS progression (CNSprog), and exploratory safety endpoints. Results: The SOC arm included 119 patients in 1 L and 46 in 2 L versus 60 patients in 1 L and 81 in 2 L treated with capmatinib, with balanced baseline characteristics after PSA. In 1 L, the naive comparison showed a significant benefit of capmatinib versus SOC for OS (median: 25.49 vs 14.59 months; HR 0.58; 95 % CI 0.39-0.87; P = 0.011), PFS (median: 12.45 vs 5.03 months; HR: 0.44; 95 % CI: 0.31-0.63; P < 0.001), and ORR (event rate: 68.3 vs 26.9 %; RR 2.54; 95 % CI 1.80-3.58; P < 0.001). In 2 L, OS, PFS, and ORR showed positive trends favoring capmatinib over SOC. Capmatinib treatment in the 1 L and 2 L led to significant benefit in CNSprog. PSA analyses showed consistent results to naive analysis. Exploratory safety endpoints indicated a manageable safety profile for capmatinib. Conclusions: The present study demonstrates the important role of capmatinib in providing robust clinically meaningful benefit to patients with NSCLC harboring METex14 mutations and its significant role in preventing the development of brain metastases. Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AK reports study support from Novartis. MS reports an advisory role/speaker fees from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Novartis, Pfizer, Roche, Sanofi-Aventis, Siemens Healthineers, Takeda. MS has also received research support for his institution from Amgen, Dracen Pharmaceuticals, Janssen, Novartis; and travel support from AstraZeneca, Boehringer Ingelheim, Janssen, Pfizer. MW reports institutional support from Takeda; consulting fees from Daiichi Sankyo, GlaxoSmithKline, Amgen, AstraZeneca, Janssen, Novartis, Pfizer, Roche; personal honoraria from Takeda, Roche, Amgen, and AstraZeneca; travel grant support from Amgen, and Janssen. MW also participated on data safety monitoring board for Boehringer Ingelheim. HDH reports advisory role/ personal honoraria from Amgen, Boehringer Ingelheim, Bristol-Myers Squibb; institutional financial support as local principal investigator from Amgen, AstraZeneca, AvenCell Europe GmbH, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Dracen, Merck, Novartis, Revolution Medicines; support as steering committee member and coordinating principal investigator from Amgen. JK reports advisory support on behalf of institution from Lilly Deutschland, Merck Sharp & Dohme, Amgen, Bristol-Myers Squibb, AstraZeneca, Boehringer Ingelheim, Pfizer, Roche Pharma AG, Merck Serono GmbH and Janssen-Cilag GmbH. TG reports study support from Novartis; and participation on data safety monitoring board for Bristol-Myers Squibb. SK received personal honoraria from Boehringer Ingelheim and GlaxoSmithKline; and also received grants from Deutsche Forschungsgesellschaft. SMB reports grants or contracts from Roche and Quality Initiative Pathology; and received consulting fees and personal honoraria from AstraZeneca, Bayer, Bristol Myers Squibb, Discovery Life Science, Janssen, Menarini, Merck, Novartis and Quality Initiative Pathology. AT received grants from AstraZeneca and Lilly; consulting fees from Amgen, AstraZeneca, Pierre Fabre, Sanofi, Daiichi, Merck Sharp & Dohme, Roche, Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Lilly, Takeda, Novartis; honoraria for lectures from Amgen, AstraZeneca, Pierre Fabre, Sanofi, Daiichi, Merck Sharp & Dohme, Roche, Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Lilly, Takeda, Novartis; support for attending meetings/travel from Sanofi, AstraZeneca and Pfizer; leadership role in AIO and ERS. AT also participated on the data safety monitoring board study ROSE study (AIO-YMO/TRK-0120 / ROSE). DKG received consulting fees from Boehringer Ingelheim, Pfizer, Merck Sharp & Dohme, Janssen, Bristol-Myers Squibb, Sanofi and Roche; and received support for meeting and/or travel from Takeda and Boehringer Ingelheim. KO, MZ and UJ are employees of Novartis. JW received personal honoraria/consulting fees, support for meetings and/or travel from and participated on data safety monitoring board from Amgen, AstraZeneca, Bayer, Blueprint, Bristol-Myers Squibb, Boehringer-Ingelheim, Chugai, Daiichi Sankyo, Janssen, Lilly, Loxo, Merck, Mirati, Merck Sharp & Dohme, Novartis, Nuvalent, Pfizer, Pierre-Fabre, Roche, Seattle Genetics, Takeda, Turning Point; and received research support for institution from Bristol-Myers Squibb, Janssen Pharmaceutica, Novartis, Pfizer. JK, SG, CS, MCD, MJ, CW have no conflicts of interest to disclose outside of the submitted work. (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Advanced NSCLC; Brain metastases; Capmatinib; METex14 mutations; Real-world study |
| المشرفين على المادة: | TY34L4F9OZ (capmatinib) 0 (Benzamides) EC 2.7.10.1 (Proto-Oncogene Proteins c-met) 0 (Triazines) EC 2.7.10.1 (MET protein, human) 0 (Protein Kinase Inhibitors) 0 (Antineoplastic Agents) 0 (Imidazoles) |
| تواريخ الأحداث: | Date Created: 20240628 Date Completed: 20240712 Latest Revision: 20240712 |
| رمز التحديث: | 20240713 |
| DOI: | 10.1016/j.ejca.2024.114158 |
| PMID: | 38941869 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1879-0852 |
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| DOI: | 10.1016/j.ejca.2024.114158 |