Best of ASCO - 2014 Annual Meeting



Attend this session at the
2019 ASCO Annual Meeting!

Session: Lung Cancer—Non-Small Cell Metastatic

Type: Oral Abstract Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall B1

Phase II study of tepotinib in NSCLC patients with METex14 mutations.

Metastatic Non-Small Cell Lung Cancer

Lung Cancer—Non-Small Cell Metastatic

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 9005)

Author(s): Paul K. Paik, Remi Veillon, Alexis B. Cortot, Enriqueta Felip, Hiroshi Sakai, Julien Mazieres, Frank Griesinger, Leora Horn, Helene Senellart, Jan P. Van Meerbeeck, Javier de Castro Carpeño, Jyoti D. Patel, Marina Chiara Garassino, Masahiro Morise, Niels Reinmuth, Santiago Viteri, Takaaki Tokito, Tomohiro Sakamoto, Jürgen Scheele, Xiuning Le; Memorial Sloan Kettering Cancer Center, New York, NY; CHU Bordeaux, Service Des Maladies Respiratoires, Bordeaux, France; Lille University Hospital, Univ. Lille, Lille, France; Vall d´Hebron University Hospital, Barcelona, Spain; Saitama Cancer Center, Saitama, Japan; CHU de Toulouse-Hopital Larrey, IUCT–Oncopole, Quai de Livraison Pharmacie, Toulouse, France; Pius-Hospital, University Department Internal Medicine-Oncology, Medical Campus University of Oldenburg, Oldenburg, Germany; Vanderbilt-Ingram Cancer Center, Nashville, TN; ICO Rene Gauducheau Center, Saint-Herblain, France; Antwerp University Hospital, Edegem, Belgium; Hospital Universitario HM Madrid Sanchinarro, Madrid, Spain; The University of Chicago Medical Center, Chicago, IL; Fondazione IRCCS-Istituto Nazionale dei Tumori, Milan, Italy; Nagoya University Graduate School of Medicine, Nagoya, Japan; Asklepios Lung Clinic, Munich-Gauting, Germany; Dr Rosell Oncology Institute, Dexeus University Hospital, Quiron Salud Group, Barcelona, Spain; Kurume University School of Medicine, Kurume, Japan; Tottori University Hospital, Yonago, Japan; Merck KGaA, Darmstadt, Germany; MD Anderson Cancer Center, The University of Texas, Houston, TX

Abstract Disclosures


Background: MET exon 14 skipping (METex14) mutations - reported in 3~4% of NSCLC patients (pts) - are activating, sensitive to MET inhibition and can be conveniently detected using liquid biopsy (LBx). We report data from an ongoing single-arm phase II study of tepotinib, a highly selective MET inhibitor, in NSCLC pts with METex14 mutations identified by LBx or tumor biopsy (TBx) (NCT02864992). Methods: Pts with advanced WT EGFR/ALK NSCLC, prospectively enrolled via either LBx (≥60 pts) or TBx (≥60 pts, overlap anticipated) central RNA-based METex14 mutation testing, receive tepotinib 500 mg QD until progression, intolerable toxicity or withdrawal. Primary endpoint: objective response rate (ORR) by independent review (IRC). Secondary endpoints: ORR by investigator assessment (INV) and safety. Results: To date, 85 pts have been enrolled (55 LBx pts and 52 TBx pts). At data cut-off (16 Oct 2018), in 35 evaluable LBx pts (≥2 post-baseline assessments or discontinuation for any reason), ORR was 51.4% by IRC and 63.9% by INV. In 41 evaluable TBx pts, ORR was 41.5% by IRC and 58.5% by INV. Median duration of response (mDoR) and ORR by line of treatment are shown in the table. Any grade treatment-related adverse events (TRAEs) reported by ≥10% of 69 pts evaluable for safety were peripheral edema (47.8%), diarrhea (18.8%), nausea (15.9%), asthenia (10.1%). No TRAEs were grade 4 or led to death. TRAEs led to permanent discontinuation in 2 (2.9%) pts (1 ILD, 1 diarrhea & nausea). Conclusions: Tepotinib has promising activity with a long DoR across treatment lines in NSCLC pts with METex14 mutations detected by LBx or TBx. The safety profile was favorable. Recruitment is ongoing. Clinical trial information: NCT02864992

Responders/Evaluable pts (%) [95% CI]LBx
ORR Line of therapy
1L8/12 (66.7)11/12 (91.7)6/16 (37.5)8/15 (53.3)
[34.9, 90.1][61.5, 99.8][15.2, 64.6][26.6, 78.7]
2L6/11 (54.5)7/12 (58.3)6/12 (50.0)9/13 (69.2)
[23.4, 83.3][27.7, 84.8][21.1, 78.9][38.6, 90.9]
≥3L4/12 (33.3)5/12 (41.7)5/13 (38.5)7/13 (53.8)
[9.9, 65.1][15.2, 72.3][13.9, 68.4][25.1, 80.8]
Overall ORR18/35 (51.4)23/36 (63.9)17/41 (41.5)24/41 (58.5)
[34.0, 68.6][46.2, 79.2][26.3, 57.9][42.1, 73.7]
mDoR, months (range)9.8 (1.1, 18.0)17.1 (1.3, 21.5)12.4 (1.1, 18.0)14.3 (1.3, 21.5)

Other Abstracts in this Sub-Category:


1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


3. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9000 First Author: Kazuhiko Nakagawa
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer