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Poster Discussion session - NSCLC, metastatic 1

2111 - Phase II results for single-agent nazartinib (EGF816) in adult patients (pts) with treatment-naive EGFR-mutant non-small cell lung cancer (NSCLC)


19 Oct 2018


Poster Discussion session - NSCLC, metastatic 1


Clinical Research;  Targeted Therapy

Tumour Site


Daniel Shao Weng Tan


D.S.W.S. Tan1, S. Kim2, L.V. Sequist3, S. Ponce Aix4, E.F. Smit5, T. Hida6, J.C. Yang7, E. Felip8, T. Seto9, C. Grohe10, J. Wolf11, J. Ko12, E. Marriere13, R. Belli13, M. Giovannini14, D. Kim15

Author affiliations

  • 1 National Cancer Center, National Cancer Center, 16910 - Singapore/SG
  • 2 Oncology, Asan Medical Center, Seoul/KR
  • 3 Cancer Center, Massachusetts General Hospital, 2114 - Boston/US
  • 4 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 5 Thoracic Oncology, Netherlands Cancer Institute, Amsterdam/NL
  • 6 Department Of Thoracic Oncology, Aichi Cancer Center, Nagoya/JP
  • 7 National Taiwan University, National Taiwan University Hospital, Taipei/TW
  • 8 Medical Oncology Service (lung Cancer Unit), Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 9 Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - FUKUOKA/JP
  • 10 Evangelische Lungenklinik Elk Berlin Chest Hospital, Evangelische Lungenklinik ELK Berlin Chest Hospital, 13125 - Berlin/DE
  • 11 Oncology, University Hospital Cologne, Cologne/DE
  • 12 Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 13 Oncology, Novartis Pharma AG, Basel/CH
  • 14 Oncology, Novartis Pharmaceuticals Corporation, 07906 - East Hanover/US
  • 15 Seoul National University Hospital, Seoul National University Hospital, Seoul/KR


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Abstract 2111


Nazartinib (EGF816) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that selectively targets activating (L858R, ex19del) and resistance (T790M) mutants, while sparing wild type. In this phase I/II multicenter study in advanced EGFR-mutant NSCLC (NCT02108964), the recommended phase II dose was 150 mg once daily (QD). Phase II primary efficacy and safety data are presented.


Treatment-naive pts with NSCLC harboring activating EGFR mutations (L858R and/or ex19del) received oral nazartinib 150 mg QD on a continuous schedule. Primary objective was antitumor activity (overall response rate [ORR] per RECIST v1.1) per blinded independent review committee. Secondary objectives included characterization of safety/tolerability and pharmacokinetics.


At data cutoff (22 March 2018), 45 pts were enrolled; median age 64 years, 62% Asian, 60% female, 58% ECOG PS 1, 18/45 pts (40%) had baseline brain metastases (BM). EGFR mutations were 56% ex19del, 40% L858R, 4% other. Of 45 pts, 12 discontinued nazartinib due to progressive disease (n = 9), adverse events (AEs; maculopapular rash [n = 1]), patient choice (n = 1), or death (n = 1). Median duration of exposure was 43.3 weeks. Frequent AEs (any grade ≥ 20%) regardless of causality were diarrhea (38%), maculopapular rash (31%), stomatitis (24%), cough (22%), decreased appetite (22%), pruritus (20%), and pyrexia (20%). The most frequent grade 3/4 AE (≥ 5%) regardless of cause was maculopapular rash (9%). ORR was 64% (29/45; 95% CI, 49%-78%), including 1 complete response. At data cutoff, responses were ongoing in 27/29 pts; 6-month duration of response rate was 91% (median NE), and 6-month progression-free survival and overall survival rates were 83% and 95%, respectively (medians NE). Disease control rate was 93%. In the 17 pts with baseline BM in nontarget lesions, 9 pts (53%) showed resolution of BM; 1/27 pts without baseline BMs had a new BM post-baseline.


Nazartinib demonstrated a tolerable safety profile and promising efficacy, with durable responses in treatment-naive pts with advanced EGFR-mutant NSCLC, including pts with baseline BM.

Clinical trial identification

EUDRACT number 2013-004482-14


Release date: 07-Apr-2017

Editorial Acknowledgement

Editorial assistance was provided by Zareen Khan of ArticulateScience Ltd.

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