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EGFR Mutations in NSCLC

Testing for EGFR mutations may help inform eligibility for targeted treatment in patients with NSCLC.1

Lung cancer constellation
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Testing for EGFR Mutations in Lung Cancer Can Help Guide Treatment Decisions2,3

Epidermal growth factor receptor (EGFR) mutations are actionable in non-small cell lung cancer (NSCLC), making them a potential target for therapy. 2

EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer.

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NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) Recommend Testing for EGFR Mutations in NSCLC Stage IB—IIIA, IIIB (T3, N2) and Stage IV NSCLC3

Testing for certain biomarkers at diagnosis can help support critical treatment decisions in eligible patients with resectable NSCLC3

Biomarker DNA icon

Why test

To help inform therapeutic decisions.3

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Whom to test

NCCN Guidelines® recommend testing for EGFR mutations, ALK rearrangements, and PD-L1 status for eligible patients with resectable Stage IB-IIIA, IIIB (T3, N2) NSCLC.3,a

Clinicopathologic features such as ethnicity, smoking status, or histology should NOT be used to select people for testing.3

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How to test

For EGFR mutations and ALK rearrangements, single-gene and multigene panel options are available.4–6 For PD-L1 expression levels, IHC-based assays are used.7

Importance of testing for EGFR mutations in NSCLC

Why test

To inform therapeutic decisions and eligibility for clinical trials.3

Whom to test

NCCN Guidelines® recommend EGFR biomarker testing for all histologic subtypes in people with advanced or mNSCLC.3,b

How to test

Real-time PCR, Sanger sequencing (ideally paired with tumor enrichment), and sequential or concurrent tissue or plasma next-generation sequencing (NGS) are recommended in clinical guidelines to comprehensively identify biomarkers in advanced or mNSCLC – such as EGFR mutations.3

aThe NCCN Guidelines for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.3 bNCCN also recommends testing for ALK rearrangements, BRAF mutations, ROS1 gene rearrangements, RET gene rearrangements, MET exon 14–skipping mutations, NTRK1/2/3 gene fusions, KRAS mutations, ERBB2 (HER2) mutations, and PD-L1 status in eligible people with advanced or mNSCLC.3

ALK, anaplastic lymphoma kinase; BRAF, v-Raf murine sarcoma viral oncogene homolog B; EGFR, epidermal growth factor receptor; ERBB2, erb-b2 receptor tyrosine kinase 2; FDA, US Food and Drug Administration; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; KRAS, v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; N2, node 2; NCCN, National Comprehensive Cancer Network; NGS, next-generation sequencing; NTRK, neurotrophic tyrosine receptor kinase; NSCLC, non-small cell lung cancer; mNSCLC, metastatic non-small cell lung cancer; MET, mesenchymal-epithelial transition; PD-L1, programmed death-ligand 1; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1, receptor tyrosine kinase; T3, tumor 3.

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EGFR Mutations Are One of the Most Common Actionable Oncogenic Drivers in NSCLC8

Diagram representing prevalence of EGFR mutations in NSCLC

Up to

~1 in 5

patients with stage I–III NSCLC may have an EGFR mutation9,10,a

Up to

57%

of patients with stage IB–III EGFRm NSCLC also express PD–L1 at levels ≥1%11,b

PD-L1

PD-L1

EGFRm

&

PD-L1

EGFRm

&

PD-L1

EGFRm

EGFRm

aPrevalence of EGFR mutations in NSCLC adenocarcinoma was based on data from 2 references: Sholl et al (2015) performed mutation analysis on 1007 cases with confirmed diagnosis of lung adenocarcinoma. Testing was performed on 987 cases for EGFR sensitizing mutations (exon 19 deletions, EGFR L858R mutations, EGFR G719S mutations, EGFR L861Q mutations) and other EGFR mutations (any one or more mutations in EGFR other than those mentioned previously). Out of 987 cases, 331 cases that were analyzed had stage I-III NSCLC. D’Angelo et al (2012) analyzed tumor specimens from a cohort of 1118 people with stage I-III surgically resected lung adenocarcinomas with EGFR exon 19 deletions and L858R mutations only.9,10 bEGFR mutation status and PD-L1 expression overlap was examined in a retrospective analysis of 319 people with EGFRm NSCLC across all stages. EGFR mutations included exon 19 deletions (n=145), exon 21 L858R mutations (n=121), exon 19 nondeletions (n=26), exon 21 non-L858R mutations (n=3), exon 18 mutations (n=12), and exon 20 mutations (n=8). One person had both exon 18 and exon 20 mutations and 3 people had other mutations. PD-L1 expression ≥1% was observed in 86 out of 150 people with stage IB-III EGFRm NSCLC.11

EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation-positive; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1.

Diagram representing prevalence of EGFR mutations in NSCLC 2

Up to

~1 in 4

patients with mNSCLC may have an EGFR mutation8,a

Up to

~60%

of patients with EGFRm NSCLC also express PD-L1 at levels ≥1%12–15,b

PD-L1

PD-L1

EGFRm

&

PD-L1

EGFRm

&

PD-L1

EGFRm

EGFRm

Lung cancer icon

NCCN Guidelines state that:

In mNSCLC, knowing PD-L1 status is not enough to make 1L treatment decisions as targeted therapy for the oncogenic driver should take precedence.3

Lung cancer icon

Increased EGFR signaling promotes tumor cell growth and survival2,16

EGFR mutations may lead to unregulated proliferation and survival of tumor cells, making them a key molecular driver of disease, regardless of disease stage.2,16

aJordan et al (2017) prospectively analyzed a total of 915 tumors from 860 patients with recurrent or metastatic lung adenocarcinoma for mutations in >300 cancer-associated genes using the Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT) assay, a hybridization capture-based, next-generation sequencing platform.8 bMazieres et al (2019) was a multicenter, international, retrospective study of 551 patients receiving ICI monotherapy for advanced NSCLC with at least one oncogenic driver alteration. 125 patients had an EGFR mutation. D'Incecco et al (2015) was a multicenter, retrospective, Italian study that assessed PD-L1 expression in 125 patients with mNSCLC and EGFR mutations, ALK translocations, or KRAS mutations. 56 patients had an EGFR mutation. Dietel et al (2019) was a multicenter, international, retrospective study that examined PD-L1 expression in 2368 tumor samples with histologically confirmed stage IIIB/IV primary NSCLC as classified by AJCC 7th edition. 448 patients had an EGFR mutation. Brown et al (2019) analyzed PD-L1 expression in 231 samples of untreated EGFR-mutated advanced NSCLC from the FLAURA trial of osimertinib.12–15

1L, first-line; ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation-positive; ICI, immune checkpoint inhibitor; KRAS, v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand-1.

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Consider Sample Type by Specimen and Assay Availability to Maximize Detection of Therapeutically Actionable Mutations

Integrating ctDNA alongside tissue testing may help reduce turnaround time and maximize identification of driver gene mutations in mNSCLC.3,17

Sample typeClinical relevanceLimitations
Tissue specimen
(diagnostic biopsy)
  • Tissue specimens (including resections) provide high tumor volume, which may help ensure adequate tissue for molecular testing18
  • Well-established and commonly used at diagnosis when tissue is collected as part of routine workup17,19
  • QNS and/or prolonged turnaround time can delay treatment planning20
Cytology specimen
(diagnostic)
  • Biomarker testing of cytology specimens from pleural fluid can be used as an alternative to tissue testing21
  • Cytology specimens may provide limited material which may pose challenges for pathology22
Liquid biopsy (ctDNA)
  • Minimally invasive, requires only a small amount of blood, and avoids complications of biopsies23
  • Likely to better reflect tumor heterogeneity23
  • Lower tumor burden may decrease sensitivity of ctDNA analysis24
Concurrent liquid biopsy (ctDNA) and tissue biopsy
  • Concurrent testing may:
    • Deliver comprehensive results faster3
    • Help provide actionable results even in cases of tissue QNS25,a
    • Maximize the detection of therapeutically actionable mutations25,26,a,b
    • Reduce time to diagnosis which may result in earlier initiation of appropriate treatment27,c
  • Negative results by one method suggests the use of a complementary method3
  • Lack of standardization and training prevents implementation into clinical routine28
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Unlike ctDNA analysis used in mNSCLC, liquid biopsy (ctDNA) molecular testing has not been clinically validated in the resectable NSCLC setting.29,34


Mutation detection in ctDNA may be challenging in the resectable setting due to lower tumor burden and less shedding of tumor DNA.29,34

Tissue testing remains essential in resectable and metastatic settings, while plasma ctDNA is only clinically validated in mNSCLC.19,29

Sample typeClinical relevanceLimitations
Tissue specimen
(preoperative biopsy)
  • A preoperative biopsy may be useful for patients with ≥Stage IB NSCLC who may be candidates for systemic therapy prior to surgery3
  • Preoperative biopsy samples may not always be sufficient for both diagnosis and biomarker testing30
Tissue specimen
(surgical resection sample)
  • Surgically resected tissue provides high tumor volume, which may help ensure adequate tissue for molecular testing30
  • Can be painful, invasive, costly, and time consuming31
Cytology specimen
  • Cytology specimens with adequate cellularity and preservation are suitable for biomarker testing according to the CAP/IASLC/AMP guidelines32
  • The diagnosis of NSCLC made on cytology (sputum, TTNA, bronchoscopic specimens, or pleural fluid) is reliable in people suspected of having NSCLC33
    • However, adequate tissue should be obtained to accurately define the histological type and to perform molecular analysis when applicable33
  • Cytology specimens may provide limited material which may pose challenges for pathology22

Mutation detection in ctDNA may be challenging in the resectable setting due to lower tumor burden and less shedding of tumor DNA.29,34

aIn a single center prospective, cohort study of 323 patients with mNSCLC, 229 received concurrent testing. Therapeutically targetable mutations were detected in 113 patients, among whom 66 had the mutation detected in plasma only, 16 patients in tissue only, and 31 patients in plasma and tissue. Mutations for 35 of 113 patients (31%) were detected in plasma only when tissue DNA was insufficient or unavailable, or no mutation was detected in tissue.25 bIn a prospective analysis of 282 patients with previously untreated mNSCLC undergoing physician discretion SOC tissue genotyping and submitted a pre-treatment blood sample for comprehensive cfDNA analysis, the addition of cfDNA testing identified a guideline recommended biomarker in 32% (n=90/282) of patients who otherwise would not have had guideline-complete genotyping.26 cA retrospective study comparing patients with mNSCLC who underwent tissue genotyping alone (n=78) vs patients who underwent concurrent liquid and tissue genotyping (n=42) revealed a shorter mean time to diagnosis when undergoing concurrent testing (33.5 days vs 20.6 days respectively; p<0.001).27

AMP, Association for Molecular Pathology; CAP, College of American Pathologists; cfDNA, cell-free deoxyribonucleic acid; ctDNA, circulating tumor deoxyribonucleic acid; EGFR, epidermal growth factor receptor; IASLC, International Association for the Study of Lung Cancer; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; QNS, quantity not sufficient; SoC, standard of care; TTNA, transthoracic needle aspiration.

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Utilize Diagnostic Assays for EGFR Mutation Testing to Help Inform Treatment Options35

Results may be ready in hours to within 2 weeks, depending on the type of test and where it is donea

Laboratory and test nameGenes or alterations assessedMinimum sample requirementsTurnaround time
Send-out
Foundation Medicine
FoundationOne®CDx5,6,36,b		324FFPE block or ≥11 unstained slidesMedian 8.8 days
Foundation Medicine
FoundationOne®LiquidCDx37,b		>300Blood: 2 tubes, 8.5 mL each<2 weeks
Guardant Health
Guardant360® CDx38,39,b		55Blood: Minimum of 5 mL≤7 days
Caris® Life Sciences
Caris Molecular Intelligence®
Tumor Profiling40,41,b		~23,000FFPE block or 25 unstained slides10–14 days
TEMPUS
Tempus xT (RUO)42,43,c		648FFPE block or 10 unstained slides + 1 H&E slide9 days
NeoGenomics
NeoTYPE® Lung Tumor Profile (RUO)44,c		Analyzes 49 biomarkers through a combination of methodsFFPE tissue (block)14 days
In house
Thermo Fisher
Oncomineâ„¢ Dx Target Test45,b		2310 ng of DNA and RNA from FFPE tissue4 days
Roche
cobas® EGFR Mutation Test v2 Solid Tumor4,46,47,b		11 × 5 μm FFPE tissue section OR 2 mL plasma<8 hours for tissue workflow
and <4 hours for plasma
workflow
Qiagen
therascreen® EGFR RGQ PCR48,b		1FFPE clockNot reported
Biocartis
Idylla™ EGFR Mutation Assay (RUO)49,c		11 × 5 μm FFPE tissue section2.5 hours
Thermo Fisher
Oncomineâ„¢ Precision Assay (RUO)50,c		5010 ng of DNA or RNA1 day
test tube symbol represents laboratories that offer concurrent testing

Represents laboratories or assays that offer concurrent testing

AstraZeneca is not affiliated with and does not control these websites. Inclusion of a website on AZPrecisionMed.com does not constitute endorsement of its content by the associated organizations.

aThis document is intended as educational information and is not intended as a complete list of available testing options. AstraZeneca is not responsible for any test provider and does not endorse any particular diagnostic test. The accuracy and results of diagnostic tests vary, and AstraZeneca shall have no liability arising from such testing. Information provided herein should in no way be considered a guarantee of coverage, reimbursement, or patient assistance. Providers should contact third-party laboratories for information on their patient assistance programs. While diagnostic testing may assist providers in identifying appropriate treatment for patients, the decision and action should be decided by a provider in consultation with the patient. All products are trademarks of their respective holders, all rights reserved. bFDA approved companion diagnostic. cThis assay is not an FDA-approved companion diagnostic. The listed mutations detected by this assay could be informative for the treatment of NSCLC.

CDx, companion diagnostic; cfDNA, circulating cell-free deoxyribonucleic acid; DNA, deoxyribonucleic acid; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; FFPE, formalin-fixed paraffin-embedded; H&E, hematoxylin and eosin; NSCLC, non-small cell lung cancer; PCR, polymerase chain reaction; RNA, ribonucleic acid; RUO, research use only.

Scientist looking at and holding lab samples

Browse a selection of major laboratories offering a range of biomarker testing options.

Find a testing lab
This information is intended as educational and is not intended as a complete list of available testing options. AstraZeneca is not responsible for any test provider and does not endorse any particular diagnostic test. The accuracy and results of diagnostic tests vary, and AstraZeneca shall have no liability arising from such testing. Information provided herein should in no way be considered a guarantee of coverage, reimbursement, or patient assistance. Providers should contact third-party laboratories for information on their patient assistance programs. While diagnostic testing may assist providers in identifying appropriate treatment for patients, the decision and action should be decided by a provider in consultation with the patient. All products are trademarks of their respective holders, all rights reserved.

Find a list of FDA cleared or approved companion diagnostics.35

View diagnostic devices
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AstraZeneca is not affiliated with and does not control these websites. Inclusion of a website on AZPrecisionMed.com does not constitute endorsement of its content by the associated organizations.

FDA, US Food and Drug Administration.

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Accurate Interpretation and Reporting of Biomarker Test Results May Help to Ensure an Appropriate Diagnosis51

The American Society of Clinical Oncology has provided guidance on information to include for biomarker test reporting in cancer.

Reports should include basic information about the test such as51:

  • Elevation arrows

    Detection limits

  • Cells under magnifying glass

    Genes and gene regions evaluated

  • Biomarker detection

    Variants detected

    Including single nucleotide variants, insertion/deletion mutations, copy number variations, gene fusions, and gene expression

  • Failed biomarker detection

    Variants that may not be detected

The College of American Pathologists provides a template for interpreting and reporting results of biomarker testing of specimens from patients with NSCLC.52

View CAP reporting template
Two healthcare providers looking at a computer screen

AstraZeneca is not affiliated with and does not control these websites. Inclusion of a website on AZPrecisionMed.com does not constitute endorsement of its content by the associated organizations.

CAP, College of American Pathologists; NSCLC, non-small cell lung cancer.

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Considerations for Your Practice

Implement EGFR mutation testing protocols or standardize those already in place to ensure all eligible people with NSCLC can receive fully informed treatment options.

  • Follow NCCN Guidelines recommending EGFR testing for eligible patients with resectable stage IB to IIIA and stage IIIB (T3, N2) NSCLC
  • Find solutions to common challenges you may face during biomarker testing

EGFR, epidermal growth factor receptor; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer.

Helpful Resources

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Download Best practices in implementing biomarker testing for metastatic NSCLC
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FOR HCPS

Best practices in implementing biomarker testing for metastatic NSCLC

Read about complete biomarker profiling for informing treatment in metastatic non-small cell lung cancer (mNSCLC), and best practices for performing biomarker testing.

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Lack of evidence for use of IO therapy in first line treatment of EGFRm mNSCLC

Hear Dr. Charu Aggarwal discuss the lack of evidence for use of immunotherapy (IO) in first-line treatment of epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (mNSCLC).

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Informing resectable NSCLC treatment options through biomarker testing

View this helpful guide on biomarker testing for patients with non-small cell lung cancer (NSCLC).

View more resources 

EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation-positive; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer.

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