Association between gene expression signatures and clinical outcomes of pembrolizumab versus paclitaxel in advanced gastric cancer: exploratory analysis from the randomized, controlled, phase III KEYNOTE-061 trial
BackgroundIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit...
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| Published in: | Journal for ImmunoTherapy of Cancer Vol. 11; no. 6; p. e006920 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
BMJ Publishing Group Ltd
01.06.2023
BMJ BMJ Publishing Group LTD BMJ Publishing Group |
| Series: | Original research |
| Subjects: | |
| ISSN: | 2051-1426, 2051-1426 |
| Online Access: | Get full text |
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| Abstract | BackgroundIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.MethodsUsing RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10).ResultsRNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel.ConclusionsThis exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis.Trial registration number NCT02370498. |
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| AbstractList | Background In the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.Methods Using RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10).Results RNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel.Conclusions This exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis.Trial registration number NCT02370498. In the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial. Using RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (Tcell GEP) and 10 non-Tcell GEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for Tcell GEP (prespecified α=0.05) and the 10 non-Tcell GEP signatures (multiplicity-adjusted; prespecified α=0.10). RNA sequencing data were available for 137 patients in each treatment group. Tcell GEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The Tcell GEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the Tcell GEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel. This exploratory analysis of tumor Tcell GEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. Tcell GEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis. NCT02370498. BackgroundIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.MethodsUsing RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10).ResultsRNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel.ConclusionsThis exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis.Trial registration numberNCT02370498. In the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.BACKGROUNDIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.Using RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10).METHODSUsing RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10).RNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel.RESULTSRNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel.This exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis.CONCLUSIONSThis exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis.NCT02370498.TRIAL REGISTRATION NUMBERNCT02370498. BackgroundIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.MethodsUsing RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (TcellinfGEP) and 10 non-TcellinfGEP signatures (angiogenesis, glycolysis, granulocytic myeloid-derived suppressor cell (gMDSC), hypoxia, monocytic MDSC (mMDSC), MYC, proliferation, RAS, stroma/epithelial-to-mesenchymal transition/transforming growth factor-β, WNT). The association between each signature on a continuous scale and outcomes was analyzed using logistic (objective response rate (ORR)) and Cox proportional hazards regression (progression-free survival (PFS) and OS). One-sided (pembrolizumab) and two-sided (paclitaxel) p values were calculated for TcellinfGEP (prespecified α=0.05) and the 10 non-TcellinfGEP signatures (multiplicity-adjusted; prespecified α=0.10).ResultsRNA sequencing data were available for 137 patients in each treatment group. TcellinfGEP was positively associated with ORR (p=0.041) and PFS (p=0.026) for pembrolizumab but not paclitaxel (p>0.05). The TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR (p=0.077), PFS (p=0.057), and OS (p=0.033) for pembrolizumab, while the TcellinfGEP-adjusted glycolysis (p=0.018), MYC (p=0.057), and proliferation (p=0.002) signatures were negatively associated with OS for paclitaxel.ConclusionsThis exploratory analysis of tumor TcellinfGEP showed associations with ORR and PFS for pembrolizumab but not for paclitaxel. TcellinfGEP-adjusted mMDSC signature was negatively associated with ORR, PFS, and OS for pembrolizumab but not paclitaxel. These data suggest myeloid-driven suppression may play a role in resistance to PD-1 inhibition in G/GEJ cancer and support a strategy of considering immunotherapy combinations which target this myeloid axis.Trial registration number NCT02370498. |
| Author | Ryu, Min-Hee Loboda, Andrey Shitara, Kohei Mandala, Mario Shih, Chie-Schin Cristescu, Razvan Wainberg, Zev A Di Bartolomeo, Maria Caglevic, Christian Olesinski, Tomasz Chung, Hyun Cheol Mansoor, Wasat Cao, Z Alexander Goekkurt, Eray Özgüroğlu, Mustafa Muro, Kei Kobie, Julie McDermott, Raymond S Nebozhyn, Michael |
| AuthorAffiliation | 2 Department of Immunology , Nagoya University Graduate School of Medicine , Nagoya , Japan 4 Unit of Medical Oncology , University of Perugia , Perugia , Italy 5 Department of Oncology , University of Ulsan College of Medicine, Asan Medical Center , Seoul , Korea (the Republic of) 11 St Vincent’s University Hospital & Cancer Trials , Dublin , Ireland 13 Division of Hematology/Oncology , David Geffen School of Medicine at UCLA , Los Angeles , California , USA 10 Hematology-Oncology Practice Eppendorf (HOPE) and University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf , Hamburg , Germany 7 Department of Gastrointestinal Cancers and Neuroendocrine Tumors Surgery , Maria Sklodowska–Curie National Research Institute of Oncology , Warsaw , Poland 6 Cancer Research Department , Instituto Oncologico Fundacion Arturo Lopez Perez , Santiago , Chile 9 Department of Clinical Oncology , Aichi Cancer Center Hospital , Nagoya , Japan 12 Christie Hospital NHS Foundation Trust, Univ |
| AuthorAffiliation_xml | – name: 7 Department of Gastrointestinal Cancers and Neuroendocrine Tumors Surgery , Maria Sklodowska–Curie National Research Institute of Oncology , Warsaw , Poland – name: 12 Christie Hospital NHS Foundation Trust, University of Manchester , Manchester , UK – name: 4 Unit of Medical Oncology , University of Perugia , Perugia , Italy – name: 10 Hematology-Oncology Practice Eppendorf (HOPE) and University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf , Hamburg , Germany – name: 5 Department of Oncology , University of Ulsan College of Medicine, Asan Medical Center , Seoul , Korea (the Republic of) – name: 1 Department of Gastrointestinal Oncology , National Cancer Center Hospital East , Kashiwa , Japan – name: 3 Department of Medical Oncology , Fondazione IRCCS Istituto Nazionale dei Tumori , Milan , Italy – name: 2 Department of Immunology , Nagoya University Graduate School of Medicine , Nagoya , Japan – name: 9 Department of Clinical Oncology , Aichi Cancer Center Hospital , Nagoya , Japan – name: 8 Division of Medical Oncology , Yonsei Cancer Center, Yonsei University College of Medicine , Seoul , Korea (the Republic of) – name: 6 Cancer Research Department , Instituto Oncologico Fundacion Arturo Lopez Perez , Santiago , Chile – name: 11 St Vincent’s University Hospital & Cancer Trials , Dublin , Ireland – name: 15 Division of Medical Oncology, Clinical Trial Unit , Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine , Istanbul , Turkey – name: 14 Merck & Co Inc , Rahway , New Jersey , USA – name: 13 Division of Hematology/Oncology , David Geffen School of Medicine at UCLA , Los Angeles , California , USA |
| Author_xml | – sequence: 1 givenname: Kohei orcidid: 0000-0001-5196-3630 surname: Shitara fullname: Shitara, Kohei email: kshitara@east.ncc.go.jp organization: Department of Immunology, Nagoya University Graduate School of Medicine, Nagoya, Japan – sequence: 2 givenname: Maria surname: Di Bartolomeo fullname: Di Bartolomeo, Maria organization: Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy – sequence: 3 givenname: Mario orcidid: 0000-0001-8846-8959 surname: Mandala fullname: Mandala, Mario organization: Unit of Medical Oncology, University of Perugia, Perugia, Italy – sequence: 4 givenname: Min-Hee surname: Ryu fullname: Ryu, Min-Hee organization: Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of) – sequence: 5 givenname: Christian surname: Caglevic fullname: Caglevic, Christian organization: Cancer Research Department, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile – sequence: 6 givenname: Tomasz orcidid: 0000-0001-6492-4331 surname: Olesinski fullname: Olesinski, Tomasz organization: Department of Gastrointestinal Cancers and Neuroendocrine Tumors Surgery, Maria Sklodowska–Curie National Research Institute of Oncology, Warsaw, Poland – sequence: 7 givenname: Hyun Cheol surname: Chung fullname: Chung, Hyun Cheol organization: Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea (the Republic of) – sequence: 8 givenname: Kei surname: Muro fullname: Muro, Kei organization: Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan – sequence: 9 givenname: Eray surname: Goekkurt fullname: Goekkurt, Eray organization: Hematology-Oncology Practice Eppendorf (HOPE) and University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany – sequence: 10 givenname: Raymond S surname: McDermott fullname: McDermott, Raymond S organization: St Vincent’s University Hospital & Cancer Trials, Dublin, Ireland – sequence: 11 givenname: Wasat surname: Mansoor fullname: Mansoor, Wasat organization: Christie Hospital NHS Foundation Trust, University of Manchester, Manchester, UK – sequence: 12 givenname: Zev A surname: Wainberg fullname: Wainberg, Zev A organization: Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA – sequence: 13 givenname: Chie-Schin surname: Shih fullname: Shih, Chie-Schin organization: Merck & Co Inc, Rahway, New Jersey, USA – sequence: 14 givenname: Julie surname: Kobie fullname: Kobie, Julie organization: Merck & Co Inc, Rahway, New Jersey, USA – sequence: 15 givenname: Michael surname: Nebozhyn fullname: Nebozhyn, Michael organization: Merck & Co Inc, Rahway, New Jersey, USA – sequence: 16 givenname: Razvan surname: Cristescu fullname: Cristescu, Razvan organization: Merck & Co Inc, Rahway, New Jersey, USA – sequence: 17 givenname: Z Alexander surname: Cao fullname: Cao, Z Alexander organization: Merck & Co Inc, Rahway, New Jersey, USA – sequence: 18 givenname: Andrey surname: Loboda fullname: Loboda, Andrey organization: Merck & Co Inc, Rahway, New Jersey, USA – sequence: 19 givenname: Mustafa surname: Özgüroğlu fullname: Özgüroğlu, Mustafa organization: Division of Medical Oncology, Clinical Trial Unit, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey |
| BackLink | https://cir.nii.ac.jp/crid/1871146593249771648$$DView record in CiNii https://www.ncbi.nlm.nih.gov/pubmed/37399357$$D View this record in MEDLINE/PubMed |
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| Copyright | Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2023 |
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| Keywords | Programmed Cell Death 1 Receptor Gene Expression Profiling Gastrointestinal Neoplasms Genetic Markers Immunotherapy |
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| License | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/. Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
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mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors publication-title: J Immunother Cancer doi: 10.1136/jitc-2021-003091 – ident: 2025100312495118000_11.6.e006920.15 doi: 10.1200/JCO.2018.78.2276 – ident: 2025100312495118000_11.6.e006920.24 doi: 10.1186/s40425-019-0643-8 – ident: 2025100312495118000_11.6.e006920.3 doi: 10.1016/j.annonc.2022.07.004 – volume: 39 start-page: 147 year: 2019 ident: 2025100312495118000_11.6.e006920.6 article-title: Mechanisms of resistance to immune checkpoint blockade: why does checkpoint inhibitor immunotherapy not work for all patients? publication-title: Am Soc Clin Oncol Educ Book doi: 10.1200/EDBK_240837 – volume: 40 year: 2022 ident: 2025100312495118000_11.6.e006920.31 article-title: A randomized phase 3 study evaluating the efficacy and safety of first-line Pembrolizumab plus Lenvatinib plus chemotherapy versus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma: LEAP-015 publication-title: JCO doi: 10.1200/JCO.2022.40.4_suppl.TPS369 – volume: 17 year: 2018 ident: 2025100312495118000_11.6.e006920.27 article-title: Biomarkers for predicting efficacy of PD-1/PD-L1 inhibitors publication-title: Mol Cancer doi: 10.1186/s12943-018-0864-3 – ident: 2025100312495118000_11.6.e006920.5 – ident: 2025100312495118000_11.6.e006920.10 doi: 10.5858/arpa.2018-0043-OA – ident: 2025100312495118000_11.6.e006920.32 doi: 10.1016/S1470-2045(14)70420-6 – volume: 10 year: 2022 ident: 2025100312495118000_11.6.e006920.23 article-title: Influence of tumor mutational burden, inflammatory gene expression profile, and PD-L1 expression on response to Pembrolizumab in head and neck squamous cell carcinoma publication-title: J Immunother Cancer doi: 10.1136/jitc-2021-003026 – volume: 7 start-page: 895 year: 2021 ident: 2025100312495118000_11.6.e006920.11 article-title: Assessment of Pembrolizumab therapy for the treatment of microsatellite instability-high gastric or gastroesophageal junction cancer among patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 clinical trials publication-title: JAMA Oncol doi: 10.1001/jamaoncol.2021.0275 – ident: 2025100312495118000_11.6.e006920.19 doi: 10.1093/bioinformatics/bts294 – ident: 2025100312495118000_11.6.e006920.9 – volume: 30 start-page: v916 year: 2019 ident: 2025100312495118000_11.6.e006920.25 article-title: Association between tissue TMB (tTMB) and clinical outcomes with Pembrolizumab monotherapy (Pembro) in PD-L1-positive advanced NSCLC in the KEYNOTE-010 and -042 trials publication-title: Annals of Oncology doi: 10.1093/annonc/mdz394.077 – volume: 40 start-page: 2505 year: 2022 ident: 2025100312495118000_11.6.e006920.29 article-title: Phase 1 first-in-human study of anti–ILT3 mAb MK-0482 as monotherapy and in combination with Pembrolizumab in advanced solid tumors: dose escalation results publication-title: JCO doi: 10.1200/JCO.2022.40.16_suppl.2505 – volume: 32 start-page: 1127 year: 2021 ident: 2025100312495118000_11.6.e006920.1 article-title: Molecular determinants of clinical outcomes with pembrolizumab versus paclitaxel in a randomized, open-label, phase III trial in patients with gastroesophageal adenocarcinoma publication-title: Ann Oncol doi: 10.1016/j.annonc.2021.05.803 – ident: 2025100312495118000_11.6.e006920.4 doi: 10.3322/caac.21660 – ident: 2025100312495118000_11.6.e006920.8 doi: 10.1038/s41591-018-0101-z – volume: 28 start-page: 1680 year: 2022 ident: 2025100312495118000_11.6.e006920.12 article-title: Transcriptomic determinants of response to Pembrolizumab monotherapy across solid tumor types publication-title: Clin Cancer Res doi: 10.1158/1078-0432.CCR-21-3329 – ident: 2025100312495118000_11.6.e006920.7 doi: 10.1038/s41590-017-0022-x – ident: 2025100312495118000_11.6.e006920.28 doi: 10.1158/1541-7786.MCR-20-0622 – volume: 25 start-page: 197 year: 2022 ident: 2025100312495118000_11.6.e006920.17 article-title: Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial publication-title: Gastric Cancer doi: 10.1007/s10120-021-01227-z – volume: 28 start-page: 2050 year: 2022 ident: 2025100312495118000_11.6.e006920.22 article-title: Putative biomarkers of clinical benefit with pembrolizumab in advanced urothelial cancer: results from the KEYNOTE-045 and KEYNOTE-052 landmark trials publication-title: Clin Cancer Res doi: 10.1158/1078-0432.CCR-21-3089 – volume: 31 start-page: 607 year: 2021 ident: 2025100312495118000_11.6.e006920.2 article-title: Advances in systemic therapy for gastric cancer publication-title: Gastrointest Endosc Clin N Am doi: 10.1016/j.giec.2021.03.009 – volume: 30 start-page: v917 year: 2019 ident: 2025100312495118000_11.6.e006920.26 article-title: Pembrolizumab (Pembro) plus platinum-based chemotherapy (Chemo) for metastatic NSCLC: tissue TMB (tTMB) and 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| Snippet | BackgroundIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus... In the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in... Background In the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus... |
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| SubjectTerms | Angiogenesis Antibodies Antibodies, Monoclonal, Humanized Antibodies, Monoclonal, Humanized - therapeutic use Cancer Cancer therapies Cell death Clinical outcomes Clinical/Translational Cancer Immunotherapy Gastric cancer Gastrointestinal Neoplasms Gene expression Gene Expression Profiling Genetic Markers Growth factors Humanized Humans Hypoxia Immunotherapy Medical prognosis Metastasis Monoclonal Monoclonal antibodies Neoplasms. Tumors. Oncology. Including cancer and carcinogens Paclitaxel Paclitaxel - pharmacology Paclitaxel - therapeutic use Patients Programmed Cell Death 1 Receptor RC254-282 Response rates Review boards Stomach Neoplasms Stomach Neoplasms - drug therapy Stomach Neoplasms - genetics Stomach Neoplasms - pathology Targeted cancer therapy Transcriptome Tumors |
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| Title | Association between gene expression signatures and clinical outcomes of pembrolizumab versus paclitaxel in advanced gastric cancer: exploratory analysis from the randomized, controlled, phase III KEYNOTE-061 trial |
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