Educate your patients about first-line TAGRISSO

In a global, Phase III study in metastatic EGFRm NSCLC

Patients were progression free almost twice as long vs erlotinib/gefitinib1

Patients were progression free almost twice as long vs erlotinib/gefitinib Patients were progression free almost twice as long vs erlotinib/gefitinib

  • This means that patients who started with TAGRISSO had nearly 9 months more time before their disease progressed vs patients taking erlotinib/gefitinib

In a global, Phase III study in metastatic EGFRm NSCLC

Patients' median Overall Survival was beyond 3 years for patients on TAGRISSO2

Patients' median Overall Survival was beyond 3 years for patients on TAGRISSO Patients' median Overall Survival was beyond 3 years for patients on TAGRISSO

Osimertinib (TAGRISSO) is the only NCCN preferred first-line therapy option in metastatic EGFRm NSCLC Osimertinib (TAGRISSO) is the only National Comprehensive Cancer Network® (NCCN®) preferred first-line therapy option in metastatic EGFRm NSCLC.3 * *The 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.

In a global, Phase III study in metastatic EGFRm NSCLC

First-line TAGRISSO reduced the risk of CNS progression in patients with CNS metastases at baseline by 52% vs erlotinib/gefitinib; HR=0.48 (95% CI: 0.26, 0.86); P=0.0144

  • Median CNS PFS not reached with first-line TAGRISSO (95% CI: 16.5, NC) vs 13.9 months (95% CI: 8.3, NC) for erlotinib/gefitinib
  • CNS PFS results only take into account progression in the CNS

Results from patients with CNS metastases at baseline1

Results from patients with CNS metastases at baseline Results from patients with CNS metastases at baseline

  • This means that among the patients with baseline CNS metastases treated with TAGRISSO, 77% had a confirmed response and 18% did not have any evidence of CNS disease1
  • This was a preplanned, exploratory analysis4

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.1,4-6†

†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.4

CI, confidence interval; CNS, central nervous system; DoR, duration of response; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; HR, hazard ratio; NC, not calculable; NSCLC, non-small cell lung cancer; OS, Overall Survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors; TKI, tyrosine kinase inhibitor.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 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 of Medical Oncology; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA5. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.6.2020. ©National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed June 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. 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.] 5. 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]. 6. 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.

IMPORTANT SAFETY INFORMATION

  • There are no contraindications for TAGRISSO
  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients; 0.3% 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 1479 TAGRISSO-treated patients in clinical trials, 0.8% were found to have a QTc >500 msec, and 3.1% 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 3% of the 1479 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 3.2% of 1233 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. 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 1479 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
  • Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
  • 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 (≥20%) adverse reactions, including laboratory abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough

INDICATIONS

  • TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with 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

  • TAGRISSO is indicated for the first-line treatment of adult 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

  • TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

For additional information, please see the complete Prescribing Information, including Patient Information.

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