Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer

Soria, Jean-Charles; Ohe, Yuichiro; Vansteenkiste, Johan; Reungwetwattana, Thanyanan; Chewaskulyong, Busyamas; Lee, Ki Hyeong; Dechaphunkul, Arunee; Imamura, Fumio; Nogami, Naoyuki; Kurata, Takayasu; Okamoto, Isamu; Zhou, Caicun; Cho, Byoung Chul; Cheng, Ying; Cho, Eun Kyung; Voon, Pei Jye; Planchard, David; Su, Wu-Chou; Gray, Jhanelle E.; Lee, Siow-Ming; Hodge, Rachel; Marotti, Marcelo; Rukazenkov, Yuri; Ramalingam, Suresh S.

doi:10.1056/nejmoa1713137

Cited by 5,508Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer

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Soria, Jean-Charles, Ohe, Yuichiro, Vansteenkiste, Johan, Reungwetwattana, Thanyanan, Chewaskulyong, Busyamas, Lee, Ki Hyeong, Dechaphunkul, Arunee, Imamura, Fumio +16 more·2018·New England Journal of Medicine

DOI 10.1056/nejmoa1713137

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Abstract

BACKGROUND: Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). METHODS: In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1:1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). The primary end point was investigator-assessed progression-free survival. RESULTS: The median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P<0.001). The objective response rate was similar in the two groups: 80% with osimertinib and 76% with standard EGFR-TKIs (odds ratio, 1.27; 95% CI, 0.85 to 1.90; P=0.24). The median duration of response was 17.2 months (95% CI, 13.8 to 22.0) with osimertinib versus 8.5 months (95% CI, 7.3 to 9.8) with standard EGFR-TKIs. Data on overall survival were immature at the interim analysis (25% maturity). The survival rate at 18 months was 83% (95% CI, 78 to 87) with osimertinib and 71% (95% CI, 65 to 76) with standard EGFR-TKIs (hazard ratio for death, 0.63; 95% CI, 0.45 to 0.88; P=0.007 [nonsignificant in the interim analysis]). Adverse events of grade 3 or higher were less frequent with osimertinib than with standard EGFR-TKIs (34% vs. 45%). CONCLUSIONS: Osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation-positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125 .).

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In the FLAURA trial, first-line osimertinib led to superior PFS and OS compared with a first-generation TKI (gefitinib or erlotinib).
“in the recent FLAURA head-to-head trial, first-line treatment with osimertinib led to superior PFS and OS compared with a first-generation TKI (gefitinib or erlotinib).”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [13]
The Abstract reports significantly longer progression-free survival with first-line osimertinib than with gefitinib or erlotinib. It does not establish superior overall survival: the Abstract says the interim survival data were immature and the result was nonsignificant; the Results (p. 120) give P=0.007, above the prespecified interim threshold of P<0.0015. (LLM, conf=0.90)
Experimental — accuracy not yet measured
Patients who do not develop T790M upon progression on first- or second-generation EGFR TKIs may have been better treated with osimertinib as first-line therapy, which has shown the longest median PFS of all EGFR TKIs at 18.9 months in FLAURA.
“Patients who do not develop T790M upon progression on first- or second-generation EGFR TKIs may have been better treated with osimertinib as first-line therapy, which has shown the longest median PFS of all EGFR TKIs, at 18.9 months (assessed by investigator review) in the FLAURA trial.”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [13]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
In the FLAURA trial, 12% of patients treated with osimertinib and 17% treated with first-generation EGFR TKIs died without commencing second-line therapy.
“In the FLAURA trial, 12% of patients treated with osimertinib and 17% treated with first-generation EGFR TKIs died without commencing a second-line therapy.”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [13]
The Results (pp. 116, 120) report deaths and initiation of subsequent anticancer therapy separately. They do not report the claimed 12% and 17% who died without starting second-line therapy; the overall death rates of 21% and 30% measure something different. (LLM, conf=0.81)
Experimental — accuracy not yet measured
Osimertinib has demonstrated efficacy in patients with brain metastases and appears superior to first-generation TKIs in treating CNS metastases and reducing incidence of de novo CNS lesions.
“osimertinib has also demonstrated efficacy in patients with brain metastases.13,81 Based on analysis of CNS activity in the FLAURA trial, osimertinib appears superior to first-generation TKIs in treating CNS metastases and in reducing the incidence of de novo CNS lesions.”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [13]
The Efficacy section reports a progression-free-survival benefit in patients with or without known or treated CNS metastases, and fewer CNS progression events with osimertinib than with gefitinib or erlotinib (6% versus 15%). It does not separately establish a reduction in de novo CNS lesions. The Trial Assessments section notes that routine brain imaging was required only for patients with confirmed CNS metastases, limiting detection of new, asymptomatic lesions. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Osimertinib selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations, with lower activity against wild-type EGFR.
“osimertinib, selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations, with lower activity against wild-type EGFR.”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [13]

Duration of response, progression-free survival, and overall survival are even more variable across these trials.
“Even more variable are duration of response to targeted therapy, progression-free survival and overall survival16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [20]
In first-line targeted therapy trials for oncogene-addicted NSCLC, objective response rates typically range from 50% to 83%, complete responses are rare, and some patients show de novo resistance.
“Across clinical trials of first-line targeted therapy for oncogene-addicted subgroups of NSCLC, rates of objective response [G] typically range between 50% and 83% and complete responses [G] are rare; in addition, some patients exhibit de novo resistance16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [20]
Targeted therapies are approved for patients with classical EGFR mutations and a small number of other mutations.
“Targeted therapies are approved for patients with ‘classical’ mutations and a small number of other mutations4–6.”
From Structure-based classification predicts drug response in EGFR-mutant NSCLC (2021) · cites this paper as [6]
Patients with classical EGFR mutations show marked improvements in clinical outcomes when treated with first-, second- or third-generation tyrosine kinase inhibitors (TKIs).
“Patients with classical EGFR mutations (L858R or exon 19 deletions (Ex19del)) show marked improvements in clinical outcomes when treated with first-, second- or third-generation tyrosine kinase inhibitors (TKIs)4–6,11.”
From Structure-based classification predicts drug response in EGFR-mutant NSCLC (2021) · cites this paper as [6]
Osimertinib showed a significant PFS benefit compared with erlotinib or gefitinib in first-line EGFR-mutant NSCLC in the FLAURA trial.
“when compared to erlotinib or gefitinib in the first-line setting for EGFR mutant NSCLC, osimertinib showed a significant PFS benefit in favor of osimertinib in a phase III study (FLAURA trial, NCT02296125) [4].”
From Landscape of EGFR-Dependent and -Independent Resistance Mechanisms to Osimertinib and Continuation Therapy Beyond Progression in EGFR -Mutant NSCLC (2018) · cites this paper as [4]
In the first line setting, EGFR-TKIs have shown efficacy, particularly with osimertinib.
“In the first line setting, EGFR-tyrosine kinase inhibitors have shown efficacy, particularly with osimertinib. 21 22”
From Sacituzumab tirumotecan versus docetaxel for previously treated EGFR -mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial (2025) · cites this paper as [21]

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Authors: Soria, J.-C., Ohe, Y., Vansteenkiste, J., Reungwetwattana, T., Chewaskulyong, B., Lee, K. H., Dechaphunkul, A., Imamura, F., Nogami, N., Kurata, T., Okamoto, I., Zhou, C., Cho, B. C., Cheng, Y., Cho, E. K., Voon, P. J., Planchard, D., Su, W.-C., Gray, J. E., Lee, S.-M., Hodge, R., Marotti, M., Rukazenkov, Y., & Ramalingam, S. S.
Affiliations: Université Paris-Sud (FR)
From Gustave Roussy Cancer Campus and University Paris-Sud, Orsay, France (J.-C.S., D.P.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital (T.K.), Osaka, the Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama (N.N.), and the Research Institute for Diseases of the...
ORCID: Soria, Jean-Charles
Ohe, Yuichiro
Vansteenkiste, Johan
Reungwetwattana, Thanyanan
Lee, Ki Hyeong
Dechaphunkul, Arunee
Imamura, Fumio
Nogami, Naoyuki
Kurata, Takayasu
Okamoto, Isamu
Zhou, Caicun
Cho, Byoung Chul
Cheng, Ying
Voon, Pei Jye
Planchard, David
Su, Wu-Chou
Gray, Jhanelle E.
Lee, Siow-Ming
Hodge, Rachel
Ramalingam, Suresh S.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2018-01-11
Volume: 378
Issue: 2
Pages: 113-125
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1713137
OpenAlex: W2770828094
Cited by: 5,508
References: 33
Citations by year: 2026: 570 · 2025: 699 · 2024: 690 · 2023: 621 · 2022: 714 · 2021: 700 · 2020: 669 · 2019: 547 · 2018: 280 · 2017: 8 · 2016: 1
FWCI: 340.91
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
QUT ePrints (Queensland University of Technology) (submittedVersion)
YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Lirias (submittedVersion)
Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion, other-oa)
Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
Zurich Open Repository and Archive (University of Zurich)
Funders: AstraZeneca
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: osimertinib, EGFR-mutant non-small cell lung cancer, EGFR tyrosine kinase inhibitors, gefitinib, erlotinib, exon 19 deletion, L858R mutation, progression-free survival, objective response rate, first-line therapy, irreversible EGFR inhibitors, overall survival, duration of response
MeSH terms: Erlotinib Hydrochloride, Gefitinib, Acrylamides, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Double-Blind Method, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Mutation, Piperazines, Protein-Tyrosine Kinases, Pyrimidines, Quinazolines, Survival Rate, Disease-Free Survival, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors

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Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer

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