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Update on recent key publications in lung oncology: picking up speed

Achim Rittmeyer, Annett Schiwitza, Lejla Sahovic, Bastian Eul, Stefan Andreas
European Respiratory Review 2021 30: 200300; DOI: 10.1183/16000617.0300-2020
Achim Rittmeyer
1Lungenfachklinik Immenhausen, Immenhausen, Germany
4Both authors contributed equally
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  • For correspondence: arittmeyer@lungenfachklinik-immenhausen.de
Annett Schiwitza
2Dept of Pneumology (Research & Teaching), Universitätsmedizin Göttingen, Deutsches Zentrum Lungenforschung (DZL), Göttingen, Germany
4Both authors contributed equally
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  • ORCID record for Annett Schiwitza
Lejla Sahovic
2Dept of Pneumology (Research & Teaching), Universitätsmedizin Göttingen, Deutsches Zentrum Lungenforschung (DZL), Göttingen, Germany
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Bastian Eul
3Dept of Pneumology, Medical Oncology, Hematology, Universitätsklinikum Gießen-Marburg, Giessen, Germany
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Stefan Andreas
1Lungenfachklinik Immenhausen, Immenhausen, Germany
2Dept of Pneumology (Research & Teaching), Universitätsmedizin Göttingen, Deutsches Zentrum Lungenforschung (DZL), Göttingen, Germany
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Figures

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  • FIGURE 1
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    FIGURE 1

    PRISMA flow diagram.

  • FIGURE 2
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    FIGURE 2

    Numbers representing European Medicines Agency approved drugs within their substance class in lung oncology. Blue: chemotherapy (CT); green: targeted agents (tyrosine kinase inhibitors); red: VEGF-inhibitors; yellow: immune checkpoint inhibitors. VEGF: vascular endothelial growth factor.

  • FIGURE 3
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    FIGURE 3

    Correlation of sample size and date of publication regarding approved combinations (blue line and squares), TKIs (orange line and triangles) and single drugs except TKIs (green line and dots). The black line shows the correlation of sample size and date for all approved drugs and combinations. TKI trimmed (red line): shows data without the two first trials for erlotinib and gefitinib [18, 20]. TKI: tyrosine kinase inhibitor.

  • FIGURE 4
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    FIGURE 4

    Time intervals between the publications of linked phase I and phase III trials. Correlation coefficient r= −0.82303; p=0.00001. Estimated rate over time shown along with a 95% credible region.

Tables

  • Figures
  • Supplementary Materials
  • TABLE 1

    Approved drugs in lung oncology, 2000–2020

    Chemical nameLine of therapyPhase I trial
    (first author [ref.])
    Trial leading to approval (first author [ref.])Sample sizeEMA approval dateApproval trial phaseHistologyClassMonoclonal antibodyRoute of administrationPrimary end-point trial leading to approval
    DocetaxelSecondExtra [13]Shepherd [14]n=1036 February 2000IIINSCLCChemotherapyNoi.v.MOS
    Pemetrexed SecondMcDonald [15]Hanna [16]n=57122 September 2004IIInsNSCLC#ChemotherapyNoi.v.MOS
    ErlotinibSecondHidalgo [17]Shepherd [18]n=73127 June 2005IIINSCLCTargeted agent¶NoOralMOS
    GefitinibAnyBaselga [19]Mok [20]n=12171 July 2009IIInsNSCLCTargeted agentNoOralPFS
    ErlotinibFirstHidalgo [17]Rosell [21]n=1741 November 2011IIInsNSCLCTargeted agentNoOralPFS
    CrizotinibSecondKwak [22]Shaw [11]n=34724 October 2012IIIROS1/ALK+NSCLC+Targeted agentNoOralPFS
    AfatinibFirstYap [23]Sequist [24]n=34525 September 2013IIIEGFR+nsNSCLCTargeted agentNoOralPFS
    CeritinibSecondShaw [25]Shaw [26]n=2318 May 2015IIIALK+NSCLCTargeted agentNoOralPFS
    NivolumabSecondBrahmer [27]Brahmer [28]n=27220 July 2015IIISqNSCLCImmune checkpointYesi.v.MOS
    CrizotinibFirstKwak [22]Solomon [29]n=34324 November 2015IIIROS1/ALK+NSCLC+Targeted agentNoOralPFS
    OsimertinibSecondCross [30]Mok [31]n=4193 February 2016IIIEGFR M+NSCLCTargeted agentNoOralPFS
    NivolumabSecondBrahmer [27]Borghaei [32]n=5826 April 2016IIInsNSCLCImmune checkpointYesi.v.MOS
    AfatinibSecondYap [23]Thongprasert [33]n=607 April 2016IIIEGFR+NSCLCTargeted agentNoOralORR
    PembrolizumabSecondGaron [34]Herbst [35]n=10342 August 2016IIIPD-L1 >1%+NSCLCImmune checkpointYesi.v.MOS PFS§
    PembrolizumabFirstGaron [34]Reck [36]n=30531 January 2017IIIPD-L1 >50% NSCLCImmune checkpointYesi.v.PFS
    AlectinibSecondSeto [37]Shaw [38]n=8721 February 2017IIALK+NSCLCTargeted agentNoOralORR
    Dabrafenib/trametinibAnyFalchook [39]Planchard [40]n=363 April 2017IIBRAf V600E+NSCLCTargeted agentNoOralORR
    AtezolizumabSecondHerbst [41]Rittmeyer [42]n=112522 September 2017IIINSCLCImmune checkpointYesi.v.MOSƒ
    AlectinibFirstSeto [37]Peters [43]n=30321 December 2017IIIALK+NSCLCTargeted agentNoOralPFS
    OsimertinibFirstCross [30]Soria [44]n=5568 June 2018IIIEGFR M+NSCLCTargeted agentNoOralPFS
    DurvalumabConsolidationAntonia [45]Antonia [46]n=70927 July 2018IIINSCLCImmune checkpointYesi.v.MOS PFS§
    BrigatinibSecondGettinger [47]Camidge [48]n=27527 November 2018IIIALK+ NSCLCTargeted agentNoOralPFS
    DacomitinibFirstTakahashi [49]Wu [50]n=4523 April 2019IIIEGFR M+NSCLCTargeted agentNoOralPFS
    LorlatinibSecondShaw [51]Solomon [52]n=2767 May 2019IIALK+NSCLCTargeted agentNoOralORRƒ
    LarotrectinibAnyDrilon [53]Drilon [53]n=5523 September 2019IINTRK+NSCLCTargeted agentNoOralORR
    BrigatinibFirstGettinger [47]Hubert [54]n=2226 April 2020IIIALK+ NSCLCTargeted agentNoOralORR

    #: first approval was granted for any NSCLC but after subgroup analyses of three trials employing pemetrexed the approval was restricted to nsNSCLC for lack of efficiency in squamous NSCLC [62]. ¶: although later approved as a targeted agent, the drug was first approved for any NSCLC without any mandatory companion diagnostic to detect a targetable mutation.

    +: Pfizer [55].

    §: for details please refer to full publication as alpha was split applying different statistical plans. ƒ: and intracranial tumour response. EMA: European Medicines Agency; NSCLC: nonsmall cell lung cancer; MOS: median overall survival; nsNSCLC: nonsquamous nonsmall cell lung cancer; PFS: progression free survival; ALK: anaplastic lymphoma kinase; EGFR: epidermal growth factor receptor; SqNSCLC: squamous nonsmall cell lung cancer; EGFR M+NSCLC: EGFR mutation positive NSCLC; ORR: objective response rate according to RECIST 1.1

    • TABLE 2

      Approved drug combinations in lung oncology, 2000–2020

      Chemical nameLine of therapyPhase ITrial leading to approvalSample sizeEMA approval dateApproval trial phaseHistologyClassMonoclonal antibodyRoute of administrationPrimary end-point trial leading to approval
      Bevacizumab/paclitaxel/carboplatinFirstWillett (Phase I) [56]; Johnson (Phase II) [57]Sandler [58]n=87823 August 2007IIInsNSCLCTargeted agentYesi.v.MOS
      Pemetrexed/cisplatinFirstThödtmann [59]Scagliotti [60]n=172528 October 2011IIInsNSCLCCT/CTNoi.v.MOS
      Nintedanib/docetaxelSecondMross [61]Reck [62]n=132427 November 2014IIInsNSCLCTargeted agentNoOralPFS
      nabPaclitaxel/carboplatinFirstRizvi [63]Socinski [64]n=10522 March 2015IIISqNSCLCChemotherapyNoi.v.ORR
      Docetaxel/ramucirumabSecondSpratlin [65]Garon [66]n=182528 January 2016IIInsNSCLCTargeted agentYesi.v.MOS
      Gemcitabine/cisplatin/necitumumabFirstKuenen [67]Thatcher [68]n=109324 February 2016IIISqNSCLCTargeted agentYesi.v.MOS
      Pembrolizumab/(nab)Paclitaxel/carboplatinFirstGadgeel [69]Paz-Ares [70]n=55914 March 2019IIISqNSCLCICP/CT/CTYesi.v.MOS PFS
      Pembrolizumab/pemetrexed/platinFirstGadgeel [69]Gandhi [71]n=61615 March 2019IIInsNSCLCICP/CT/CTYesi.v.MOS PFS
      Atezolizumab/carboplatin/etoposideFirstHorn [72]Horn [72]n=4036 September 2019IIISCLCICP/CT/CTYesi.v.MOS PFS
      Atezolizumab/nab-Paclitaxel/carboplatinFirstLiu [73]West [74]n=7236 September 2019IIInsNSCLCICP/CT/CTYesi.v.MOS PFS
      Atezolizumab/paclitaxel/carboplatin/bevacizumabFirstLiu [73]Socinski [75]n=6926 September 2019IIInsNSCLCICP/CT/CT/TAYesi.v.MOS PFS

      EMA: European Medicines Agency; nsNSCLC: nonsquamous nonsmall cell lung cancer; MOS: median overall survival; CT: chemotherapy; PFS: progression free survival; SqNSCLC: squamous nonsmall cell lung cancer; ORR: objective response rate; ICP: immune checkpoint; SCLC: small cell lung cancer; TA: targeted agent

      Supplementary Materials

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        Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

        Supplementary_tables ERR-0300-2020_supplementary_tables

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      Update on recent key publications in lung oncology: picking up speed
      Achim Rittmeyer, Annett Schiwitza, Lejla Sahovic, Bastian Eul, Stefan Andreas
      European Respiratory Review Sep 2021, 30 (161) 200300; DOI: 10.1183/16000617.0300-2020

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      Update on recent key publications in lung oncology: picking up speed
      Achim Rittmeyer, Annett Schiwitza, Lejla Sahovic, Bastian Eul, Stefan Andreas
      European Respiratory Review Sep 2021, 30 (161) 200300; DOI: 10.1183/16000617.0300-2020
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