Osimertinib Plus Durvalumab versus Osimertinib Monotherapy in EGFR T790M–Positive NSCLC following Previous EGFR TKI Therapy: CAURAL Brief Report

Yang, James Chih-Hsin; Shepherd, Frances A.; Kim, Dong-Wan; Lee, Gyeong-Won; Lee, Jong Seok; Chang, Gee-Chen; Lee, Sung Sook; Wei, Yu-Feng; Lee, Yun Gyoo; Laus, Gianluca; Collins, Barbara; Pisetzky, Francesca; Horn, Leora

doi:10.1016/j.jtho.2019.02.001

Cited by 210Lung Cancer Treatments and MutationsCancer Immunotherapy and BiomarkersHER2/EGFR in Cancer Research

Osimertinib Plus Durvalumab versus Osimertinib Monotherapy in EGFR T790M–Positive NSCLC following Previous EGFR TKI Therapy: CAURAL Brief Report

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Yang, James Chih-Hsin, Shepherd, Frances A., Kim, Dong-Wan, Lee, Gyeong-Won, Lee, Jong Seok, Chang, Gee-Chen, Lee, Sung Sook, Wei, Yu-Feng +5 more·2019·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2019.02.001

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Abstract

INTRODUCTION: Osimertinib is a third-generation EGFR-tyrosine kinase inhibitor (TKI). Durvalumab is an anti-programmed death ligand 1 monoclonal antibody. The phase III open-label CAURAL trial (NCT02454933) investigated osimertinib plus durvalumab versus osimertinib monotherapy in patients with EGFR-TKI sensitizing and EGFR T790M mutation-positive advanced NSCLC and disease progression after EGFR-TKI therapy. METHODS: Patients were randomly assigned 1:1 to receive orally administered osimertinib (80 mg once daily) with or without durvalumab (10 mg/kg administered intravenously every 2 weeks) until progression. Treatment could continue beyond progression, providing clinical benefit continued (judged by the investigator). The amended primary objective was to assess the safety and tolerability of osimertinib plus durvalumab; efficacy was an exploratory objective. RESULTS: CAURAL recruitment was terminated early because of increased incidence of interstitial lung disease-like events in the osimertinib plus durvalumab arm from the separate phase Ib TATTON trial (NCT02143466). At termination of CAURAL recruitment, 15 patients had been randomly assigned to treatment with osimertinib and 14 to treatment with osimertinib plus durvalumab. The most common AEs were diarrhea (53% [grade ≥3 in 6% of patients]) in the osimertinib arm and rash (67% [grade ≥3 in 0 patients]) in the combination arm. One patient who had been randomized to the combination arm reported grade 2 interstitial lung disease while receiving osimertinib monotherapy (after discontinuing durvalumab therapy after one dose). The objective response rates were 80% in the osimertinib arm and 64% in the combination arm. CONCLUSION: Limited patient numbers preclude formal safety and efficacy comparisons between the two treatment arms. The combination of programmed cell death 1/programmed death ligand 1 inhibitors and EGFR-TKIs as therapy for NSCLC is not well understood, but it requires a careful approach if considered in the future.

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Because of the increased risk of treatment-associated interstitial lung disease, the phase 3 clinical trial CAURAL was stopped early.
“Because of the increased risk of treatment-associated interstitial lung disease, a phase 3 clinical trial CAURAL was stopped early [193].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [193]

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Authors: Yang, J. C.-H., Shepherd, F. A., Kim, D.-W., Lee, G.-W., Lee, J. S., Chang, G.-C., Lee, S. S., Wei, Y.-F., Lee, Y. G., Laus, G., Collins, B., Pisetzky, F., & Horn, L.
Affiliations: National Taiwan University Hospital (TW)
University of Toronto (CA)
Seoul National University (KR)
Gyeongsang National University (KR)
Taichung Veterans General Hospital (TW)
Inje University (KR)
E-Da Hospital (TW)
Kangbuk Samsung Hospital (KR)
AstraZeneca (United Kingdom) (GB)
AstraZeneca (Netherlands) (NL)
Vanderbilt University Medical Center (US)
Corresponding author: Yang, James Chih-Hsin
ORCID: Yang, James Chih-Hsin
Shepherd, Frances A.
Kim, Dong-Wan
Lee, Gyeong-Won
Lee, Jong Seok
Wei, Yu-Feng
Collins, Barbara
Horn, Leora
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2019-05
Volume: 14
Issue: 5
Pages: 933-939
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2019.02.001
OpenAlex: W2912107322
Cited by: 210
References: 17
Citations by year: 2026: 15 · 2025: 20 · 2024: 24 · 2023: 30 · 2022: 39 · 2021: 42 · 2020: 27 · 2019: 13
FWCI: 22.23
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Journal of Thoracic Oncology (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Seoul National University Open Repository (Seoul National University) (submittedVersion)
Funders: Meso Scale Diagnostics
Takeda Pharmaceuticals North America
AstraZeneca
EMD Serono (NCT02454933)
Bayer
Celgene
Eli Lilly and Company
Daiichi Sankyo Company
AbbVie
Bristol-Myers Squibb
Pfizer
Novartis
Astellas Pharma Canada
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Keywords: osimertinib, durvalumab, T790M mutation, non-small cell lung cancer, EGFR tyrosine kinase inhibitor resistance, immune checkpoint inhibitors, interstitial lung disease, safety and tolerability, combination therapy
MeSH terms: Acrylamides, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Pyrimidines, Protein Kinase Inhibitors, ErbB Receptors

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Osimertinib Plus Durvalumab versus Osimertinib Monotherapy in EGFR T790M–Positive NSCLC following Previous EGFR TKI Therapy: CAURAL Brief Report

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