Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP)

S. Peters; U. Dafni; M. Boyer; D. De Ruysscher; C. Faivre-Finn; E. Felip; P. Garrido; N. Girard; M. Guckenberger; J. Haanen; C. Le Pechoux; F. Mornex; M. Ozsahin; L. Paz-Ares; D. Planchard; D. Raben; S. Ramalingam; M. Reck; E. Smit; R. Stahel; A. Stenzinger; C. Swanton; S. Vallone; M. C. Garassino

doi:10.1093/annonc/mdy553

Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP)

S. Peters^*
, U. Dafni
, M. Boyer
, D. De Ruysscher
, C. Faivre-Finn
, E. Felip
, P. Garrido
, N. Girard
, M. Guckenberger
, J. Haanen
, C. Le Pechoux
, F. Mornex
, M. Ozsahin
, L. Paz-Ares
, D. Planchard
, D. Raben
, S. Ramalingam
, M. Reck
, E. Smit
, R. Stahel

A. Stenzinger, C. Swanton, S. Vallone, M. C. Garassino

^*Corresponding author for this work

Research output: Contribution to journal › Editorial › Academic › peer-review

Original language	English
Pages (from-to)	161-165
Number of pages	5
Journal	Annals of Oncology
Volume	30
Issue number	2
DOIs	https://doi.org/10.1093/annonc/mdy553
Publication status	Published - Feb 2019

Keywords

PROGRAMMED DEATH LIGAND-1
CLINICAL BENEFIT
RADIOTHERAPY
EXPRESSION
MAGNITUDE
PD-L1

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10.1093/annonc/mdy553Licence: CC BY-NC-ND

Cite this

Peters, S., Dafni, U., Boyer, M., De Ruysscher, D., Faivre-Finn, C., Felip, E., Garrido, P., Girard, N., Guckenberger, M., Haanen, J., Le Pechoux, C., Mornex, F., Ozsahin, M., Paz-Ares, L., Planchard, D., Raben, D., Ramalingam, S., Reck, M., Smit, E., ... Garassino, M. C. (2019). Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP). Annals of Oncology, 30(2), 161-165. https://doi.org/10.1093/annonc/mdy553

@article{946be07398c64dc99112917e221bf666,

title = "Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP)",

keywords = "PROGRAMMED DEATH LIGAND-1, CLINICAL BENEFIT, RADIOTHERAPY, EXPRESSION, MAGNITUDE, PD-L1",

author = "S. Peters and U. Dafni and M. Boyer and \{De Ruysscher\}, D. and C. Faivre-Finn and E. Felip and P. Garrido and N. Girard and M. Guckenberger and J. Haanen and \{Le Pechoux\}, C. and F. Mornex and M. Ozsahin and L. Paz-Ares and D. Planchard and D. Raben and S. Ramalingam and M. Reck and E. Smit and R. Stahel and A. Stenzinger and C. Swanton and S. Vallone and Garassino, \{M. C.\}",

note = "Funding Information: The panel is a group of multidisciplinary international lung cancer specialists who decided to independently express their opinion regarding the recent EMA decision on the restricted use of Durvalumab in stage III NSCLC. They are all independent in their views, with no intervention from the pharmaceutical industry. They have no financial interest related to this initiative or topic. SP and DDR are independent scientific advisors for AstraZeneca regarding the PACIFIC data at EMA. All advisors have reported in their COIs disclosure any relationships with AZ. The authors would like disclose the following activities: SP, Receipt of honoraria or consultation fees: Abbvie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics and Takeda; Speakers engagements: AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp and Dohme, Novartis, Pfizer, Takeda; Receipt of grants/research supports: (Sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, F. Hoffmann-La Roche, Illumina, Merck Sharp and Dohme, Merck Serono, Novartis, and Pfizer. MB, all honoraria/and research support paid to my institution: Merck, Amgen, Bristol Myers Squibb, Astra Zeneca, Genentech/Roche, Pfizer, Novartis, Beigene, Boehringer Ingelheim, Ascentage Pharma. DDR, Advisory board of Astra Zeneca, Bristol-Myers-Squibb, Roche/Genentech, Merck/Pfizer, Celgene and has received investigator initiated grants from Bristol-Myers-Squibb, Astra-Zeneca and Boehringer Ingelheim. CF-F, research funding, travel support, honoraria paid to a research account: MSD, AstraZeneca, Elekta, Pfizer. EF, Consulting, advisory role or speaker{\textquoteright}s bureau: AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol{\textendash}Myers Squibb, Celgene, Eli Lilly, Guardant Health, Merck KGaA, Merck Sharp \& Dohme, Novartis, Pfizer, Roche, Takeda, Janssen; research funding: Fundaci{\'o}n Merck Salud, Grant for Oncology Innovation EMD Serono. PG, consulting and advisory services: Roche, MSD, BMS, Boerhinger Ingelheim, Pfizer, Abbvie, Guardant Health, Novartis, Lilly, Astra-Zeneca, Jansen, Sysmex, Blueprint Medicines, Takeda; Speaking, public presentations: Roche, MSD, BMS, Pfizer, Novartis, Boerhinger Ingelheim. NG, personal financial interests: Astra-Zeneca, Bristol Myers Squibb, Hoffmann La Roche, Merck Sharp Dohme; institutional financial interests: Astra-Zeneca, Bristol Myers Squibb, Hoffmann La Roche, Merck Sharp Dohme. MG, Advisory Board: AstraZeneca; Research Support: Varian. JH, has provided consultation, attended advisory boards, and/or provided lectures for: Pfizer, Bayer, MSD, BMS, IPSEN, Novartis, Roche/ Genentech, Neon Therapeutics, Celsius Therapeutics, Gadeta BV, Immunocore, Seattle genetics and has received grant support from BMS, MSD, Novartis and Neon Therapeutics. CLP, Amgen, Astra Zeneca, Lilly, Nanobiotix, Roche: honoraria. FM, travel supports and honoraria: Astrazeneca, Merck Serono, BMS, Boheringer Ingelheim. EMO, advisory board: Astra Zeneca. LP-A, personal financial interests: Honoraria any speaker, consultancy or advisory role or similar activity: Lilly, MSD, BMS, Roche, Pharmamar, Merck, Astra-Zeneca, Novartis, Boehringer, Celgene, Servier, Sysmex, Celgene, Amgen, Incyte, Pfizer; Leadership role in any for-profit healthcare company: Genomica{\textemdash}Board Member; Institutional financial interests: Astra-Zeneca, BMS, MSD. DP, consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, MedImmune, Novartis, Pfizer, prIME Oncology, Peer CME, Roche; Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche; Clinical trials research as principal or co-investigator (Institutional financial interests): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo; Travel, Accommodations, Expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer. DR, Adboards and Honorariums in past 3 years: Astra Zeneca, Merck, Genentech, Nanobiotix, EMD Serono; Scientific advisory: Suvica; Steering committees: Astra Zeneca{\textemdash}Coast Trial, Genentech{\textemdash}IMvoke 010. Consulting {\textendash} AstraZeneca Ad Boards {\textendash} AstraZeneca, Merck, Genentech, EMD Serono, Nanobiotix, Suvica. Raben has consulted on future pacific trials in terms of radiation. SR, Advisory board meetings/consultant for Amgen, Abbvie, Astra Zeneca, Bristol Myers Squibb, Merck, Roche/Genentech, Loxo, Nektar and Takeda Pharmaceuticals. MR, honoraria for lectures and consultancy from: Abbvie, Amgen, AstraZeneca, Boehringer-Ingelheim, BMS, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche; Support for research: BMS. ES, personal financial interests: None; Institutional financial interests: Fees have been paid to my institution for speaker engagements and my attendance to advisory boards of Astra Zeneca, Bristol Myers Squibb, Bayer, Cellgene, Eli Lilly, MSD, Merck, Novartis, Pfizer, Takeda, Regeneron, Roche Genentech, Roche Diagnostics; Research support: Astra Zeneca, Bristol Myers Squibb, Merck, MSD, Roche Genentech; PI for clinical studies sponsored by Novartis, PharmaMar, Takeda, Bayer, Clovis, Eli Lilly, Amgen, Roche Genentech. RS, consultant or advisory role in the last two years: Abbvie, Astra Zeneca, Boehringer Ingelheim, MSD, Pfizer, Roche and Takeda; Speaker Honoraria in the last two years: Astra Zeneca, Boehringer Ingelheim, MSD and Roche. AS, consultant/advisory board member: AstraZeneca, Bayer, BMS, Novartis, Thermo Fisher Scientific and Illumina; speaker{\textquoteright}s honoraria from BMS, MSD, Roche, Illumina, AstraZeneca, Novartis, Bayer and Thermo Fisher as well as research funding from Chugai and BMS. CS, grant/research support: Pfizer, AstraZeneca, BMS, Ventana; honoraria or consultancy fees: Boehringer Ingelheim, Eli Lily, Servier, Novartis, Roche-Genentech, GlaxoSmithKline, Pfizer, BMS, Celgene, AstraZeneca, Illumina, Sarah Cannon Research Institute; stock options/shareholder: Apogen Biotechnologies, Epic Bioscience, GRAIL and has stock options and is cofounder of Achilles Therapeutics; patents: Method for Treating Cancer: PCT/EP2016/059401, Immune Checkpoint Intervention in Cancer: PCT/EP2016/071471, Method: PCT/GB2018/051893, Method: PCT/GB2018/051892, Method: PCT/GB2018/052004. MCG, personal financial interests, AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda; Institutional financial interests, Eli Lilly, MSD, Pfizer (MISP); AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine; Other: AIRC, AIFA, Italian Moh, TRANSCAN, research fundings. All remaining authors have declared no conflicts of interest.",

year = "2019",

month = feb,

doi = "10.1093/annonc/mdy553",

language = "English",

volume = "30",

pages = "161--165",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Elsevier Ltd",

number = "2",

}

Peters, S, Dafni, U, Boyer, M, De Ruysscher, D, Faivre-Finn, C, Felip, E, Garrido, P, Girard, N, Guckenberger, M, Haanen, J, Le Pechoux, C, Mornex, F, Ozsahin, M, Paz-Ares, L, Planchard, D, Raben, D, Ramalingam, S, Reck, M, Smit, E, Stahel, R, Stenzinger, A, Swanton, C, Vallone, S & Garassino, MC 2019, 'Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP)', Annals of Oncology, vol. 30, no. 2, pp. 161-165. https://doi.org/10.1093/annonc/mdy553

Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP). / Peters, S.; Dafni, U.; Boyer, M. et al.
In: Annals of Oncology, Vol. 30, No. 2, 02.2019, p. 161-165.

Research output: Contribution to journal › Editorial › Academic › peer-review

TY - JOUR

T1 - Position of a panel of international lung cancer experts on the approval decision for use of durvalumab in stage III non-small-cell lung cancer (NSCLC) by the Committee for Medicinal Products for Human Use (CHMP)

AU - Peters, S.

AU - Dafni, U.

AU - Boyer, M.

AU - De Ruysscher, D.

AU - Faivre-Finn, C.

AU - Felip, E.

AU - Garrido, P.

AU - Girard, N.

AU - Guckenberger, M.

AU - Haanen, J.

AU - Le Pechoux, C.

AU - Mornex, F.

AU - Ozsahin, M.

AU - Paz-Ares, L.

AU - Planchard, D.

AU - Raben, D.

AU - Ramalingam, S.

AU - Reck, M.

AU - Smit, E.

AU - Stahel, R.

AU - Stenzinger, A.

AU - Swanton, C.

AU - Vallone, S.

AU - Garassino, M. C.

N1 - Funding Information: The panel is a group of multidisciplinary international lung cancer specialists who decided to independently express their opinion regarding the recent EMA decision on the restricted use of Durvalumab in stage III NSCLC. They are all independent in their views, with no intervention from the pharmaceutical industry. They have no financial interest related to this initiative or topic. SP and DDR are independent scientific advisors for AstraZeneca regarding the PACIFIC data at EMA. All advisors have reported in their COIs disclosure any relationships with AZ. The authors would like disclose the following activities: SP, Receipt of honoraria or consultation fees: Abbvie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics and Takeda; Speakers engagements: AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp and Dohme, Novartis, Pfizer, Takeda; Receipt of grants/research supports: (Sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, F. Hoffmann-La Roche, Illumina, Merck Sharp and Dohme, Merck Serono, Novartis, and Pfizer. MB, all honoraria/and research support paid to my institution: Merck, Amgen, Bristol Myers Squibb, Astra Zeneca, Genentech/Roche, Pfizer, Novartis, Beigene, Boehringer Ingelheim, Ascentage Pharma. DDR, Advisory board of Astra Zeneca, Bristol-Myers-Squibb, Roche/Genentech, Merck/Pfizer, Celgene and has received investigator initiated grants from Bristol-Myers-Squibb, Astra-Zeneca and Boehringer Ingelheim. CF-F, research funding, travel support, honoraria paid to a research account: MSD, AstraZeneca, Elekta, Pfizer. EF, Consulting, advisory role or speaker’s bureau: AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol–Myers Squibb, Celgene, Eli Lilly, Guardant Health, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Janssen; research funding: Fundación Merck Salud, Grant for Oncology Innovation EMD Serono. PG, consulting and advisory services: Roche, MSD, BMS, Boerhinger Ingelheim, Pfizer, Abbvie, Guardant Health, Novartis, Lilly, Astra-Zeneca, Jansen, Sysmex, Blueprint Medicines, Takeda; Speaking, public presentations: Roche, MSD, BMS, Pfizer, Novartis, Boerhinger Ingelheim. NG, personal financial interests: Astra-Zeneca, Bristol Myers Squibb, Hoffmann La Roche, Merck Sharp Dohme; institutional financial interests: Astra-Zeneca, Bristol Myers Squibb, Hoffmann La Roche, Merck Sharp Dohme. MG, Advisory Board: AstraZeneca; Research Support: Varian. JH, has provided consultation, attended advisory boards, and/or provided lectures for: Pfizer, Bayer, MSD, BMS, IPSEN, Novartis, Roche/ Genentech, Neon Therapeutics, Celsius Therapeutics, Gadeta BV, Immunocore, Seattle genetics and has received grant support from BMS, MSD, Novartis and Neon Therapeutics. CLP, Amgen, Astra Zeneca, Lilly, Nanobiotix, Roche: honoraria. FM, travel supports and honoraria: Astrazeneca, Merck Serono, BMS, Boheringer Ingelheim. EMO, advisory board: Astra Zeneca. LP-A, personal financial interests: Honoraria any speaker, consultancy or advisory role or similar activity: Lilly, MSD, BMS, Roche, Pharmamar, Merck, Astra-Zeneca, Novartis, Boehringer, Celgene, Servier, Sysmex, Celgene, Amgen, Incyte, Pfizer; Leadership role in any for-profit healthcare company: Genomica—Board Member; Institutional financial interests: Astra-Zeneca, BMS, MSD. DP, consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, MedImmune, Novartis, Pfizer, prIME Oncology, Peer CME, Roche; Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche; Clinical trials research as principal or co-investigator (Institutional financial interests): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo; Travel, Accommodations, Expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer. DR, Adboards and Honorariums in past 3 years: Astra Zeneca, Merck, Genentech, Nanobiotix, EMD Serono; Scientific advisory: Suvica; Steering committees: Astra Zeneca—Coast Trial, Genentech—IMvoke 010. Consulting – AstraZeneca Ad Boards – AstraZeneca, Merck, Genentech, EMD Serono, Nanobiotix, Suvica. Raben has consulted on future pacific trials in terms of radiation. SR, Advisory board meetings/consultant for Amgen, Abbvie, Astra Zeneca, Bristol Myers Squibb, Merck, Roche/Genentech, Loxo, Nektar and Takeda Pharmaceuticals. MR, honoraria for lectures and consultancy from: Abbvie, Amgen, AstraZeneca, Boehringer-Ingelheim, BMS, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche; Support for research: BMS. ES, personal financial interests: None; Institutional financial interests: Fees have been paid to my institution for speaker engagements and my attendance to advisory boards of Astra Zeneca, Bristol Myers Squibb, Bayer, Cellgene, Eli Lilly, MSD, Merck, Novartis, Pfizer, Takeda, Regeneron, Roche Genentech, Roche Diagnostics; Research support: Astra Zeneca, Bristol Myers Squibb, Merck, MSD, Roche Genentech; PI for clinical studies sponsored by Novartis, PharmaMar, Takeda, Bayer, Clovis, Eli Lilly, Amgen, Roche Genentech. RS, consultant or advisory role in the last two years: Abbvie, Astra Zeneca, Boehringer Ingelheim, MSD, Pfizer, Roche and Takeda; Speaker Honoraria in the last two years: Astra Zeneca, Boehringer Ingelheim, MSD and Roche. AS, consultant/advisory board member: AstraZeneca, Bayer, BMS, Novartis, Thermo Fisher Scientific and Illumina; speaker’s honoraria from BMS, MSD, Roche, Illumina, AstraZeneca, Novartis, Bayer and Thermo Fisher as well as research funding from Chugai and BMS. CS, grant/research support: Pfizer, AstraZeneca, BMS, Ventana; honoraria or consultancy fees: Boehringer Ingelheim, Eli Lily, Servier, Novartis, Roche-Genentech, GlaxoSmithKline, Pfizer, BMS, Celgene, AstraZeneca, Illumina, Sarah Cannon Research Institute; stock options/shareholder: Apogen Biotechnologies, Epic Bioscience, GRAIL and has stock options and is cofounder of Achilles Therapeutics; patents: Method for Treating Cancer: PCT/EP2016/059401, Immune Checkpoint Intervention in Cancer: PCT/EP2016/071471, Method: PCT/GB2018/051893, Method: PCT/GB2018/051892, Method: PCT/GB2018/052004. MCG, personal financial interests, AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda; Institutional financial interests, Eli Lilly, MSD, Pfizer (MISP); AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine; Other: AIRC, AIFA, Italian Moh, TRANSCAN, research fundings. All remaining authors have declared no conflicts of interest.

PY - 2019/2

Y1 - 2019/2

KW - PROGRAMMED DEATH LIGAND-1

KW - CLINICAL BENEFIT

KW - RADIOTHERAPY

KW - EXPRESSION

KW - MAGNITUDE

KW - PD-L1

U2 - 10.1093/annonc/mdy553

DO - 10.1093/annonc/mdy553

M3 - Editorial

SN - 0923-7534

VL - 30

SP - 161

EP - 165

JO - Annals of Oncology

JF - Annals of Oncology

IS - 2

ER -