Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B

Xiuning Le; Luis G. Paz-Ares; Jan Van Meerbeeck; Santiago Viteri; Carlos Cabrera Galvez; Egbert F. Smit; Marina Garassino; Remi Veillon; David Vicente Baz; Jose Fuentes Pradera; María Sereno; Toshiyuki Kozuki; Young Chul Kim; Seung Soo Yoo; Ji Youn Han; Jin Hyoung Kang; Choon Hee Son; Yoon Ji Choi; Christopher Stroh; Dilafruz Juraeva; Helene Vioix; Rolf Bruns; Gordon Otto; Andreas Johne; Paul K. Paik

doi:10.1016/j.xcrm.2023.101280

Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B

Xiuning Le
, Luis G. Paz-Ares
, Jan Van Meerbeeck
, Santiago Viteri
, Carlos Cabrera Galvez
, Egbert F. Smit
, Marina Garassino
, Remi Veillon
, David Vicente Baz
, Jose Fuentes Pradera
, María Sereno
, Toshiyuki Kozuki
, Young Chul Kim
, Seung Soo Yoo
, Ji Youn Han
, Jin Hyoung Kang
, Choon Hee Son
, Yoon Ji Choi
, Christopher Stroh
, Dilafruz Juraeva

Helene Vioix, Rolf Bruns, Gordon Otto, Andreas Johne, Paul K. Paik

Department of Internal Medicine

University of Texas MD Anderson Cancer Center
Hospital Universitario 12 de Octubre
University of Antwerp
USP Institut Universitari Dexeus
Hospital Universitari Sagrat Cor
Netherlands Cancer Institute
The University of Chicago
Bordeaux University Hospital
Hospital Universitario Virgen Macarena
Hospital Universitario de Valme
Hospital Universitario Infanta Sofía
National Hospital Organization Shikoku Cancer Center
Chonnam National University
Kyungpook National University
National Cancer Center Korea
Dong-A University
Korea University
Merck KGaA
Memorial Sloan-Kettering Cancer Center
Cornell University

Research output: Contribution to journal › Article › peer-review

24 Scopus citations

Abstract

High-level MET amplification (METamp) is a primary driver in ∼1%–2% of non-small cell lung cancers (NSCLCs). Cohort B of the phase 2 VISION trial evaluates tepotinib, an oral MET inhibitor, in patients with advanced NSCLC with high-level METamp who were enrolled by liquid biopsy. While the study was halted before the enrollment of the planned 60 patients, the results of 24 enrolled patients are presented here. The objective response rate (ORR) is 41.7% (95% confidence interval [CI], 22.1–63.4), and the median duration of response is 14.3 months (95% CI, 2.8–not estimable). In exploratory biomarker analyses, focal METamp, RB1 wild-type, MYC diploidy, low circulating tumor DNA (ctDNA) burden at baseline, and early molecular response are associated with better outcomes. Adverse events include edema (composite term; any grade: 58.3%; grade 3: 12.5%) and constipation (any grade: 41.7%; grade 3: 4.2%). Tepotinib provides antitumor activity in high-level METamp NSCLC (ClinicalTrials.gov: NCT02864992).

Original language	English
Article number	101280
Journal	Cell Reports Medicine
Volume	4
Issue number	11
DOIs	https://doi.org/10.1016/j.xcrm.2023.101280
State	Published - 21 Nov 2023

Bibliographical note

Publisher Copyright:
© 2023 The Authors

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

MET amplification
MET inhibitor
biomarkers
non-small cell lung cancer
tepotinib

Access to Document

10.1016/j.xcrm.2023.101280

Cite this

Le, X., Paz-Ares, L. G., Van Meerbeeck, J., Viteri, S., Galvez, C. C., Smit, E. F., Garassino, M., Veillon, R., Baz, D. V., Pradera, J. F., Sereno, M., Kozuki, T., Kim, Y. C., Yoo, S. S., Han, J. Y., Kang, J. H., Son, C. H., Choi, Y. J., Stroh, C., ... Paik, P. K. (2023). Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B. Cell Reports Medicine, 4(11), Article 101280. https://doi.org/10.1016/j.xcrm.2023.101280

@article{ed329f7bb3d147468afdbf8fdde0098d,

title = "Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B",

abstract = "High-level MET amplification (METamp) is a primary driver in ∼1\%–2\% of non-small cell lung cancers (NSCLCs). Cohort B of the phase 2 VISION trial evaluates tepotinib, an oral MET inhibitor, in patients with advanced NSCLC with high-level METamp who were enrolled by liquid biopsy. While the study was halted before the enrollment of the planned 60 patients, the results of 24 enrolled patients are presented here. The objective response rate (ORR) is 41.7\% (95\% confidence interval [CI], 22.1–63.4), and the median duration of response is 14.3 months (95\% CI, 2.8–not estimable). In exploratory biomarker analyses, focal METamp, RB1 wild-type, MYC diploidy, low circulating tumor DNA (ctDNA) burden at baseline, and early molecular response are associated with better outcomes. Adverse events include edema (composite term; any grade: 58.3\%; grade 3: 12.5\%) and constipation (any grade: 41.7\%; grade 3: 4.2\%). Tepotinib provides antitumor activity in high-level METamp NSCLC (ClinicalTrials.gov: NCT02864992).",

keywords = "MET amplification, MET inhibitor, biomarkers, non-small cell lung cancer, tepotinib",

author = "Xiuning Le and Paz-Ares, \{Luis G.\} and \{Van Meerbeeck\}, Jan and Santiago Viteri and Galvez, \{Carlos Cabrera\} and Smit, \{Egbert F.\} and Marina Garassino and Remi Veillon and Baz, \{David Vicente\} and Pradera, \{Jose Fuentes\} and Mar{\'i}a Sereno and Toshiyuki Kozuki and Kim, \{Young Chul\} and Yoo, \{Seung Soo\} and Han, \{Ji Youn\} and Kang, \{Jin Hyoung\} and Son, \{Choon Hee\} and Choi, \{Yoon Ji\} and Christopher Stroh and Dilafruz Juraeva and Helene Vioix and Rolf Bruns and Gordon Otto and Andreas Johne and Paik, \{Paul K.\}",

note = "Publisher Copyright: {\textcopyright} 2023 The Authors",

year = "2023",

month = nov,

day = "21",

doi = "10.1016/j.xcrm.2023.101280",

language = "English",

volume = "4",

journal = "Cell Reports Medicine",

issn = "2666-3791",

publisher = "Cell Press",

number = "11",

}

Le, X, Paz-Ares, LG, Van Meerbeeck, J, Viteri, S, Galvez, CC, Smit, EF, Garassino, M, Veillon, R, Baz, DV, Pradera, JF, Sereno, M, Kozuki, T, Kim, YC, Yoo, SS, Han, JY, Kang, JH, Son, CH, Choi, YJ, Stroh, C, Juraeva, D, Vioix, H, Bruns, R, Otto, G, Johne, A & Paik, PK 2023, 'Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B', Cell Reports Medicine, vol. 4, no. 11, 101280. https://doi.org/10.1016/j.xcrm.2023.101280

TY - JOUR

T1 - Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy

T2 - VISION Cohort B

AU - Le, Xiuning

AU - Paz-Ares, Luis G.

AU - Van Meerbeeck, Jan

AU - Viteri, Santiago

AU - Galvez, Carlos Cabrera

AU - Smit, Egbert F.

AU - Garassino, Marina

AU - Veillon, Remi

AU - Baz, David Vicente

AU - Pradera, Jose Fuentes

AU - Sereno, María

AU - Kozuki, Toshiyuki

AU - Kim, Young Chul

AU - Yoo, Seung Soo

AU - Han, Ji Youn

AU - Kang, Jin Hyoung

AU - Son, Choon Hee

AU - Choi, Yoon Ji

AU - Stroh, Christopher

AU - Juraeva, Dilafruz

AU - Vioix, Helene

AU - Bruns, Rolf

AU - Otto, Gordon

AU - Johne, Andreas

AU - Paik, Paul K.

PY - 2023/11/21

Y1 - 2023/11/21

N2 - High-level MET amplification (METamp) is a primary driver in ∼1%–2% of non-small cell lung cancers (NSCLCs). Cohort B of the phase 2 VISION trial evaluates tepotinib, an oral MET inhibitor, in patients with advanced NSCLC with high-level METamp who were enrolled by liquid biopsy. While the study was halted before the enrollment of the planned 60 patients, the results of 24 enrolled patients are presented here. The objective response rate (ORR) is 41.7% (95% confidence interval [CI], 22.1–63.4), and the median duration of response is 14.3 months (95% CI, 2.8–not estimable). In exploratory biomarker analyses, focal METamp, RB1 wild-type, MYC diploidy, low circulating tumor DNA (ctDNA) burden at baseline, and early molecular response are associated with better outcomes. Adverse events include edema (composite term; any grade: 58.3%; grade 3: 12.5%) and constipation (any grade: 41.7%; grade 3: 4.2%). Tepotinib provides antitumor activity in high-level METamp NSCLC (ClinicalTrials.gov: NCT02864992).

AB - High-level MET amplification (METamp) is a primary driver in ∼1%–2% of non-small cell lung cancers (NSCLCs). Cohort B of the phase 2 VISION trial evaluates tepotinib, an oral MET inhibitor, in patients with advanced NSCLC with high-level METamp who were enrolled by liquid biopsy. While the study was halted before the enrollment of the planned 60 patients, the results of 24 enrolled patients are presented here. The objective response rate (ORR) is 41.7% (95% confidence interval [CI], 22.1–63.4), and the median duration of response is 14.3 months (95% CI, 2.8–not estimable). In exploratory biomarker analyses, focal METamp, RB1 wild-type, MYC diploidy, low circulating tumor DNA (ctDNA) burden at baseline, and early molecular response are associated with better outcomes. Adverse events include edema (composite term; any grade: 58.3%; grade 3: 12.5%) and constipation (any grade: 41.7%; grade 3: 4.2%). Tepotinib provides antitumor activity in high-level METamp NSCLC (ClinicalTrials.gov: NCT02864992).

KW - MET amplification

KW - MET inhibitor

KW - biomarkers

KW - non-small cell lung cancer

KW - tepotinib

UR - https://www.scopus.com/pages/publications/85176095439

U2 - 10.1016/j.xcrm.2023.101280

DO - 10.1016/j.xcrm.2023.101280

M3 - Article

C2 - 37944528

AN - SCOPUS:85176095439

SN - 2666-3791

VL - 4

JO - Cell Reports Medicine

JF - Cell Reports Medicine

IS - 11

M1 - 101280

ER -

Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B

Abstract

Bibliographical note

UN SDGs

Keywords

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