Medical Industry Feature: Key Data on a First-Line Treatment Option for EGFRm mNSCLC

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Key Data on a First-Line Treatment Option for EGFRm mNSCLC

Program Information

Program Information

Key Data on a First-Line Treatment Option for EGFRm mNSCLC

Please see complete Prescribing Information for TAGRISSO® (osimertinib) including Patient Information.

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  • Overview

    Join Dr. Tracey Evans as she discusses the efficacy data for TAGRISSO® (osimertinib) and the potential impact for metastatic EGFRm NSCLC patients.

    In 2018, first-line TAGRISSO became a standard of care for metastatic EGFRm NSCLC with an unprecedented 18.9 months median PFS vs 10.2 months for erlotinib/gefitinib (HR=0.46 [95% CI: 0.37, 0.57]; P<0.0001).1

    Now, TAGRISSO is the only EGFR TKI to deliver statistically significant Overall Survival beyond 3 years in a global, phase 3 randomized clinical trial in the first-line setting, (38.6 months vs 31.8 months for erlotinib/gefitinib (HR=0.799 [95.05% CI: 0.641, 0.997]; P=0.0462)).2

    Visit to learn what these data could mean for your patients.

    FLAURA study design: Randomized, double-blind, active-controlled trial in 556 patients with metastatic EGFRm NSCLC who had not received prior systemic treatment for advanced disease. Patients were randomized 1:1 to either TAGRISSO (n=279; 80 mg orally, once daily) or EGFR-TKI comparator (n=277; gefitinib 250 mg or erlotinib 150 mg orally, once daily). All US patients in the comparator arm received erlotinib. Crossover was allowed for patients in the EGFR-TKI comparator arm at confirmed progression if positive for the EGFR T790M resistance mutation. Patients with CNS metastases not requiring steroids and with stable neurologic status were included in the study. The primary endpoint of the study was PFS based on investigator assessment (according to RECIST v1.1). Secondary endpoints included OS, ORR, CNS PFS, and DoR.1,3-5*

    *A hierarchic procedure was used to adjust for multiplicity in testing the key endpoints of PFS, OS, and CNS PFS. To provide strong control for the type I error rate, the primary endpoint of PFS and endpoints of OS and CNS PFS were tested sequentially.5


    • There are no contraindications for TAGRISSO
    • Interstitial lung disease (ILD)/pneumonitis occurred in 3.9% of the 1142 TAGRISSO-treated patients; 0.4% of cases were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
    • Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 1142 TAGRISSO-treated patients in clinical trials, 0.9% were found to have a QTc >500 msec, and 3.6% 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
    • Cardiomyopathy occurred in 2.6% of the 1142 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.9% of 908 patients who had baseline and at least one follow-up LVEF assessment. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    • Keratitis was reported in 0.7% of 1142 patients treated with TAGRISSO in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
    • Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed
    • Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose
    • Most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite

    TAGRISSO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

    Please see complete Prescribing Information including Patient Information.

    You may report side effects related to AstraZeneca products by clicking here.

    References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): final overall survival analysis [oral presentation]. Presented at: European Society for Medical Oncology; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA5. 3. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125. 4. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125 [protocol]. 5. Reungwetwattana T, Nakagawa K, Cho BC, et al. CNS response to osimertinib versus standard epidermal growth factor receptor tyrosine kinase inhibitors in patients with untreated EGFR-mutated advanced non-small-cell lung cancer. J Clin Oncol. 2018. doi:10.1200/JCO.2018.78.3118. [Epub ahead of print.]                                                                               

    This product information is intended for US Healthcare Professionals only.

    The Information Center at AstraZeneca
    1800 Concord Pike, PO Box 15437, Wilmington, DE 19850-5437
    TAGRISSO is a registered trademark of the AstraZeneca group of companies.
    ©2020 AstraZeneca. All rights reserved. US-35540 Last Updated 2/20

Programs 4/13/21