PMID- 38001589
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231127
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 15
IP  - 22
DP  - 2023 Nov 8
TI  - Amivantamab Compared with Real-World Physician's Choice after Platinum-Based 
      Therapy from a Pan-European Chart Review of Patients with Lung Cancer and 
      Activating EGFR Exon 20 Insertion Mutations.
LID - 10.3390/cancers15225326 [doi]
LID - 5326
AB  - Patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth 
      factor receptor gene (EGFR) Exon 20 insertions (Exon20ins) at the second line and 
      beyond (2L+) have an unmet need for new treatment. Amivantamab, a bispecific 
      EGFR- and MET-targeted antibody, demonstrated efficacy in this setting in the 
      phase 1b, open-label CHRYSALIS trial (NCT02609776). The primary objective was to 
      compare the efficacy of amivantamab to the choices made by real-world physicians 
      (RWPC) using an external control cohort from the real-world evidence (RWE) chart 
      review study, CATERPILLAR-RWE. Adjustment was conducted to address differences in 
      prognostic variables between cohorts using inverse probability weighting (IPW) 
      and covariate adjustments based on multivariable regression. In total, 114 
      patients from CHRYSALIS were compared for 55 lines of therapy from 
      CATERPILLAR-RWE. Baseline characteristics were comparable between the amivantamab 
      and IPW-weighted RWPC cohorts. For amivantamab versus RWPC using IPW adjustment, 
      the response rate ratio for the overall response was 2.14 (p = 0.0181), and the 
      progression-free survival (PFS), time-to-next-treatment (TTNT) and overall 
      survival (OS) hazard ratios (HRs) were 0.42 (p < 0.0001), 0.47 (p = 0.0063) and 
      0.48 (p = 0.0207), respectively. These analyses provide evidence of clinical and 
      statistical benefits across multiple outcomes and adjustment methods, of 
      amivantamab in platinum pre-treated patients with advanced NSCLC harboring EGFR 
      Exon20ins. These results confirm earlier comparisons versus pooled national 
      registry data.
FAU - Christopoulos, Petros
AU  - Christopoulos P
AUID- ORCID: 0000-0002-7966-8980
AD  - Thoraxklinik and National Center for Tumor Diseases at Heidelberg University 
      Hospital, 69126 Heidelberg, Germany.
AD  - German Center for Lung Research (DZL), 35392 Giessen, Germany.
FAU - Girard, Nicolas
AU  - Girard N
AD  - Institut Curie, Institut du Thorax Curie-Montsouris, 75005 Paris, France.
AD  - Paris Saclay University, University of Versailles Saint-Quentin-en-Yvelines 
      (UVSQ), 78000 Versailles, France.
FAU - Proto, Claudia
AU  - Proto C
AUID- ORCID: 0000-0003-0287-9787
AD  - Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      20133 Milan, Italy.
FAU - Soares, Marta
AU  - Soares M
AUID- ORCID: 0000-0002-6071-3673
AD  - Instituto Portugues de Oncologia do Porto Francisco Gentil, 4200-072 Porto, 
      Portugal.
FAU - Lopez, Pilar Garrido
AU  - Lopez PG
AUID- ORCID: 0000-0002-5899-6125
AD  - Instituto Ramon y Cajal de Investigacion Sanitaria (IRYCIS), Hospital 
      Universitario Ramon y Cajal, 28034 Madrid, Spain.
FAU - van der Wekken, Anthonie J
AU  - van der Wekken AJ
AD  - University of Groningen, University Medical Centre Groningen, 9713 GZ Groningen, 
      The Netherlands.
FAU - Popat, Sanjay
AU  - Popat S
AUID- ORCID: 0000-0003-2087-4963
AD  - The Royal Marsden Hospital, London SW3 6JJ, UK.
AD  - The Institute of Cancer Research, London SW7 3RP, UK.
FAU - Diels, Joris
AU  - Diels J
AUID- ORCID: 0000-0002-9456-9120
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Schioppa, Claudio A
AU  - Schioppa CA
AUID- ORCID: 0000-0002-4148-4676
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Sermon, Jan
AU  - Sermon J
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Rahhali, Nora
AU  - Rahhali N
AD  - Janssen-Cilag Ltd., 92130 Issy-les-Moulineaux, France.
FAU - Pick-Lauer, Corinna
AU  - Pick-Lauer C
AD  - Janssen-Cilag GmbH, 41470 Neuss, Germany.
FAU - Adamczyk, Agnieszka
AU  - Adamczyk A
AD  - Janssen-Cilag Ltd., 28042 Madrid, Spain.
FAU - Penton, James
AU  - Penton J
AD  - Janssen-Cilag Ltd., High Wycombe HP12 4EG, UK.
FAU - Wislez, Marie
AU  - Wislez M
AUID- ORCID: 0000-0001-7518-7859
AD  - Hopital Cochin, APHP, 75014 Paris, France.
LA  - eng
GR  - NA/Janssen Pharmaceutica NV/
PT  - Journal Article
DEP - 20231108
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC10670157
OTO - NOTNLM
OT  - EGFR Exon 20 insertion mutations
OT  - adjusted comparison
OT  - amivantamab
OT  - non-small cell lung cancer
OT  - real-world physician's choice
COIS- As stated above, this research was funded by Janssen Pharmaceutica NV. All 
      Janssen authors contributed to the design of the study, the collection, analysis 
      and interpretation of data, the writing of the manuscript, and the decision to 
      publish the results. Petros Christopoulos: Research funding from AstraZeneca, 
      Amgen, Boehringer Ingelheim, Novartis, Roche, and Takeda; advisory 
      board/speaker's honoraria from AstraZeneca, Boehringer Ingelheim, Chugai, Daiichi 
      Sankyo, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Takeda, and 
      Thermo Fisher; all outside the submitted work. Nicolas Girard: 
      Consulting/advisory role for AbbVie, AstraZeneca, Boehringer Ingelheim, 
      Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, 
      PharmaMar, Roche, Sanofi, and Takeda; travel, accommodations, expenses for 
      AstraZeneca, BMS, MSD Oncology, and Roche; research funding from AstraZeneca, 
      Boehringer Ingelheim, and Roche. Claudia Proto: Consulting/advisory role for 
      AstraZeneca, Bristol-Myers Squibb, Janssen, MSD, Roche, and Sanofi; travel, 
      accommodation, expenses for AstraZeneca, Bristol-Myers Squibb, MSD, and Roche; 
      institutional research funding from AstraZeneca, Eli Lilly Roche, MSD, Spectrum 
      Pharmaceutical, Janssen, and Pfizer. Marta Soares: Consulting/advisory role for 
      AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim Janssen, Eli Lilly, Merck 
      Serono, MSD, Novartis, Pfizer, Roche, and Takeda. Pilar Garrido Lopez: 
      Consultancy/honoraria from AbbVie, Amgen, AstraZeneca, Bayer, Boehringer 
      Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, 
      Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and Takeda; direct funding from 
      Medscape and Touch Medical; institutional research funding from Amgen, 
      AstraZeneca, Blueprint, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi 
      Sankyo, Eli Lilly, GlaxoSmithKline, Janssen, IO Biotech, MSD, Roche, and Takeda. 
      Anthonie J. van der Wekken: Grants and personal fees from AstraZeneca, Boehringer 
      Ingelheim, Janssen, Pfizer, Roche, and Takeda; personal fees from Amgen, Lilly, 
      and Merck; outside the submitted work and all payments to the UMCG. Sanjay Popat: 
      Consultancy/honoraria from Amgen, AstraZeneca, Bayer, BeiGene, Blueprint, 
      Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, EQRx, 
      GlaxoSmithKline, Guardant Health, Janssen, Merck KGaA, MSD, Novartis, Pfizer, 
      Roche, Sanofi, Seattle Genetics, Takeda, and Turning Point Therapeutics; direct 
      funding from Elsevier, Medscape, Touch Medical, and VJ Oncology; institutional 
      research funding from Amgen, AstraZeneca, Blueprint, Boehringer Ingelheim, 
      Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Guardant 
      Health, Janssen, MSD, Roche, Takeda, Seattle Genetics, Trizel, and Turning Point 
      Therapeutics. Joris Diels: Employee of Janssen and shareholder of Johnson & 
      Johnson. Claudio A. Schioppa: Employee of Janssen and shareholder of Johnson & 
      Johnson. Jan Sermon: Employee of Janssen and shareholder of Johnson & Johnson. 
      Nora Rahhali: Employee of Janssen and shareholder of Johnson & Johnson. Corinna 
      Pick-Lauer: Employee of Janssen. Agnieszka Adamczyk: Employee of Janssen and 
      shareholder of Johnson & Johnson. James Penton: Employee of Janssen and 
      shareholder of Johnson & Johnson. Marie Wislez: Consulting/advisory role from 
      AstraZeneca, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, and 
      Takeda; travel, accommodations, expenses from AstraZeneca, Bristol-Myers Squibb, 
      MSD, and Roche.
EDAT- 2023/11/25 12:45
MHDA- 2023/11/25 12:46
PMCR- 2023/11/08
CRDT- 2023/11/25 01:05
PHST- 2023/09/05 00:00 [received]
PHST- 2023/10/30 00:00 [revised]
PHST- 2023/11/02 00:00 [accepted]
PHST- 2023/11/25 12:46 [medline]
PHST- 2023/11/25 12:45 [pubmed]
PHST- 2023/11/25 01:05 [entrez]
PHST- 2023/11/08 00:00 [pmc-release]
AID - cancers15225326 [pii]
AID - cancers-15-05326 [pii]
AID - 10.3390/cancers15225326 [doi]
PST - epublish
SO  - Cancers (Basel). 2023 Nov 8;15(22):5326. doi: 10.3390/cancers15225326.