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When patients progress, it’s time to test

 

The majority of patients with EGFRm metastatic NSCLC treated with first-line EGFR TKIs will become resistant to treatment and their disease will progress.1 The most common mechanism of acquired drug resistance is the EGFR T790M mutation, which occurs in up to 63% of patients.2

Nearly 2 out of 3 cases of acquired resistance to first-generation EGFR TKI therapy are related to the EGFR T790M mutation2

EGFR TKI Resistance Chart EGFR TKI Resistance Chart EGFR TKI Resistance Chart

Patients with metastatic EGFR NSCLC who have progressed on an EGFR TKI and harbor the T790M mutation, as detected by an FDA-approved test, may be eligible for treatment with TAGRISSO3,4

Patients with metastatic NSCLC who harbor the EGFR T790M mutation may be eligible for treatment with TAGRISSO® (osimertinib) Patients with metastatic NSCLC who harbor the EGFR T790M mutation may be eligible for treatment with TAGRISSO® (osimertinib) Patients with metastatic NSCLC who harbor the EGFR T790M mutation may be eligible for treatment with TAGRISSO® (osimertinib)

The National Comprehensive Cancer Network® (NCCN) recommends that NSCLC patients receiving a first-line EGFR TKI should be monitored for progression and tested for the T790M mutation upon progression.7

Find out about how to test for the EGFR T790M mutation.

SELECT SAFETY INFORMATION

  • There are no contraindications for TAGRISSO
  • Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.5% and was fatal in 0.6% of 833 TAGRISSO-treated patients. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms indicative of ILD (eg, dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD is confirmed See more

Options for identifying the EGFR T790M mutation may include tissue-based testing and plasma-based testing

TAGRISSO has the only FDA-approved, clinically validated companion diagnostic test for the EGFR T790M mutation that uses either tissue or plasma

The cobas® EGFR Mutation Test v2 is an FDA-approved companion diagnostic* to test for the EGFR T790M mutation from FFPE tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from peripheral whole blood.4

The cobas® EGFR Mutation Test v2 has been validated against next-generation sequencing (NGS), with FFPE tissue samples and plasma-based ctDNA samples, and has been shown to be both sensitive to and specific for the detection of EGFR T790M mutations.8,9

Options for identifying the EGFR T790M mutation may include tissue-based testing and plasma-based testing Options for identifying the EGFR T790M mutation may include tissue-based testing and plasma-based testing Confirm the Presence of the EGFR T790M Mutation Prior to Prescribing TAGRISSO
Confirm the Presence of the EGFR T790M Mutation Prior to Prescribing TAGRISSO
  • Prior to the initiation of TAGRISSO, the presence of the EGFR T790M mutation should be confirmed in tumor specimens or, in the absence of a tumor specimen, plasma specimens3
  • Testing for the presence of the EGFR T790M mutation in plasma specimens is recommended only in patients for whom a tumor biospy cannot be obtained3
  • If the EGFR T790M mutation is not detected in a plasma specimen, reevaluate the feasibility of tumor tissue testing3

FFPE= formalin-fixed paraffin-embedded.

*Companion diagnostics are in vitro diagnostic devices or imaging tools that identify patients who are most likely to benefit from a specific therapeutic agent and provide information essential for the safe and effective use of a corresponding therapeutic product.10

SELECT SAFETY INFORMATION

  • Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 833 TAGRISSO-treated patients, 0.7% of patients were found to have a QTc > 500 msec, and 2.9% of patients had an increase from baseline QTc > 60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia

Click here for additional Important Safety Information.

ORR Demonstrated with Tissue and Plasma in the Phase III Trial

  • Response rates by test type in the intent-to-treat populations. Responses did not require confirmation per RECIST v1.1

OBJECTIVE RESPONSE RATE9

Overall objective response rate was 65% for TAGRISSO and 29% for doublet chemotherapy Overall objective response rate was 65% for TAGRISSO and 29% for doublet chemotherapy Overall objective response rate was 65% for TAGRISSO and 29% for doublet chemotherapy
  • Overall objective response rate based on confirmed responses was 65% for TAGRISSO and 29% for doublet chemotherapy
Thought leaders discuss the importance of EGFR testing Thought leaders discuss the importance of EGFR testing

There are advantages and considerations for tissue and plasma samples

Both tissue and plasma samples are acceptable for use with the cobas® EGFR Mutation Test v2.8 However, both sample types have advantages and considerations.

Tissue-based testing11

Advantages

  • High sensitivity of the clinical test helps to identify patients with the mutation12
  • Common testing method so protocols may already be in place

Considerations

  • Not all patients can be tested through tissue biopsy
  • There may be potential complications involved with the collection process
  • Heterogeneity of sample may cause identification issues
STRATEGIES FOR SUCCESSFUL TISSUE BIOPSIESSTRATEGIES FOR SUCCESSFUL TISSUE BIOPSIES

Plasma-based testing11

Advantages

  • Patients (in whom a tumor biopsy cannot be obtained) are able to be tested for the EGFR T790M mutation
  • A noninvasive collection process11,13
  • Rapid turnaround time8,14,15
  • Offers a cost-effective option

Considerations

  • Due to differences in tumor biology, a negative plasma-based test may not provide conclusive results

    • Not all tumors shed enough DNA to be detected in plasma16
    • Tumor burden may vary among individuals and can affect results
  • Limited clinical data exist on the safety and efficacy of TAGRISSO in plasma-positive and tissue-negative patients

Incorporating both tests may identify more patients with metastatic NSCLC who are positive for the EGFR T790M mutation.11

When testing for the EGFR T790M mutation, a multidisciplinary approach is best*

  • Identifying an EGFR T790M mutation requires coordination across many disciplines.
  • As described in The Testing Journey: A Multidisciplinary Approach, the members of the multidisciplinary team responsible for obtaining tissue samples may include the interventional radiologist, pulmonologist, or thoracic surgeon17
When testing for the EGFR T790M mutation, a multidisciplinary approach is best. When testing for the EGFR T790M mutation, a multidisciplinary approach is best. When testing for the EGFR T790M mutation, a multidisciplinary approach is best.
Turnaround of 10 working days for EGFR mutation testing results. Turnaround of 10 working days for EGFR mutation testing results. Turnaround of 10 working days for EGFR mutation testing results.

*Showing one example of the testing approach

According to CAP/IASLC/AMP Guidelines.

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