1a86573a27f10f899b7885db2e2d33fc 301141.pdf 4c5f025f3c6063b3cfee398491bca3893cef8b82 301141.pdf 99527b34c13709cdcc8f420b0ad44619c0e50ea0712d0ba1efd733b4b9ab0962 301141.pdf Title: PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement Subject: Introduction: There are currently three first-line immunotherapy options used as monotherapy in advanced non-small cell lung cancer (NSCLC) patients with high programmed death ligand 1 (PD-L1) expression (50%). This manuscript aims to evaluate the available data on atezolizumab (AT), cemiplimab (CEMI), and pembrolizumab (PEMBRO) and to study the results obtained during pivotal trials, especially regarding patient subgroups. Methods: Nominal group and Delphi techniques were used. Eight Spanish experts in lung cancer (the scientific committee of the project) analyzed the use of immunotherapy monotherapy as first-line treatment in patients with NSCLC and high PD-L1 expression. The expert scientific committee formulated several statements based on a scientific review and their own clinical experience. Subsequently, 17 additional Spanish lung cancer experts were selected to appraise the committee’s statements through two Delphi rounds. They completed a Delphi round via an online platform and voted according to a scale from 1 (strongly disagree) to 10 (strongly agree). The statements were approved if 70% of experts voted 7 or more. Results: A total of 20 statements were proposed covering the following areas: (1) general characteristics of pivotal clinical trials; (2) overall main outcomes of pivotal clinical trials; and (3) subgroup analysis. All statements reached consensus in the first round. Conclusions: AT, CEMI, and PEMBRO as monotherapy can be considered the standard of care in patients with advanced NSCLC and high PD-L1 expression (50%). Moreover, some differences noted among the drugs analyzed in this document might facilitate treatment decision-making, especially in clinically relevant patient subgroups, when using PD-1/PD-L1 inhibitors. The high level of agreement reached among experts supports the proposed statements. Keywords: lung cancer; non-small cell lung cancer; immunotherapy; first-line treatment; PD-(L)1 inhibitors; efficacy; safety; monotherapy; consensus Author: Dolores Isla, Alfredo Sánchez, Joaquín Casal, Manuel Cobo, Margarita Majem, Noemi Reguart, Jon Zugazagoitia and Reyes Bernabé Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Tue Aug 1 09:36:19 2023 CEST ModDate: Tue Aug 1 09:48:55 2023 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 16 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 651182 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- EIFDAO+VnURWPalladioL Type 1 Custom yes yes no 10 0 RNGXBJ+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 IHYAWN+URWPalladioL-Roma Type 1 Custom yes yes no 20 0 TTDRHI+URWPalladioL-Ital Type 1 Custom yes yes no 24 0 LJZOLZ+CMSY10 Type 1 Builtin yes yes no 28 0 IOJCNK+VnURWPalladioL-Bold Type 1 Custom yes yes no 32 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 50 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 53 0 HCMLNG+Dingbats Type 1 Builtin yes yes no 81 0 JOGLDA+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 94 0 JOGLDB+PalatinoLinotype CID TrueType Identity-H yes yes yes 97 0 JOGLDC+PalatinoLinotype TrueType WinAnsi yes yes no 103 0 JOGLEE+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 106 0 JOGMIN+PalatinoLinotype TrueType MacRoman yes yes no 109 0 MPUDFL+PazoMath Type 1 Builtin yes yes no 122 0 PDXFNG+PazoMath-Bold Type 1 Builtin yes yes no 126 0 RIJDHR+CMBSY10 Type 1 Builtin yes yes no 133 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-10-01 02:43:38 CEST RepresentationInformation: 301141.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2024-09-30 11:16:45 CEST Size: 651182 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 456 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Methods Destination: section.2 Children: Item: Title: Study Design Destination: subsection.2.1 Item: Title: Expert Panel Selection and Clinical Statement Generation Destination: subsection.2.2 Item: Title: Systematic Literature Review Destination: subsection.2.3 Item: Title: Delphi Process Destination: subsection.2.4 Item: Title: Edition of the Document Destination: subsection.2.5 Item: Title: Results Destination: section.3 Children: Item: Title: Main Characteristics of Pivotal Trials Destination: subsection.3.1 Item: Title: Main Results of Pivotal Trials Destination: subsection.3.2 Item: Title: Main Results in Predefined Patient Subgroups in the Pivotal Trials Destination: subsection.3.3 Item: Title: Discussion Destination: section.4 Item: Title: References Destination: section.5 Info: Title: PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement Author: Dolores Isla, Alfredo Sánchez, Joaquín Casal, Manuel Cobo, Margarita Majem, Noemi Reguart, Jon Zugazagoitia and Reyes Bernabé Subject: Introduction: There are currently three first-line immunotherapy options used as monotherapy in advanced non-small cell lung cancer (NSCLC) patients with high programmed death ligand 1 (PD-L1) expression (50%). This manuscript aims to evaluate the available data on atezolizumab (AT), cemiplimab (CEMI), and pembrolizumab (PEMBRO) and to study the results obtained during pivotal trials, especially regarding patient subgroups. Methods: Nominal group and Delphi techniques were used. Eight Spanish experts in lung cancer (the scientific committee of the project) analyzed the use of immunotherapy monotherapy as first-line treatment in patients with NSCLC and high PD-L1 expression. The expert scientific committee formulated several statements based on a scientific review and their own clinical experience. Subsequently, 17 additional Spanish lung cancer experts were selected to appraise the committee’s statements through two Delphi rounds. They completed a Delphi round via an online platform and voted according to a scale from 1 (strongly disagree) to 10 (strongly agree). The statements were approved if 70% of experts voted 7 or more. Results: A total of 20 statements were proposed covering the following areas: (1) general characteristics of pivotal clinical trials; (2) overall main outcomes of pivotal clinical trials; and (3) subgroup analysis. All statements reached consensus in the first round. Conclusions: AT, CEMI, and PEMBRO as monotherapy can be considered the standard of care in patients with advanced NSCLC and high PD-L1 expression (50%). Moreover, some differences noted among the drugs analyzed in this document might facilitate treatment decision-making, especially in clinically relevant patient subgroups, when using PD-1/PD-L1 inhibitors. The high level of agreement reached among experts supports the proposed statements. 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