In metastatic EGFRm NSCLC

FIRST-LINE TAGRISSO:

Groundbreaking progression-free survival1

PFS IN THE PHASE 3 FLAURA STUDY

TAGRISSO Progression Free Survival (PFS) in Phase 3 FLAURA Clinical Study TAGRISSO Progression Free Survival (PFS) in Phase 3 FLAURA Clinical Study

  • In the FLAURA study, all US patients in the comparator arm received erlotinib2

First-line TAGRISSO delivered unprecedented median PFS of 18.9 months and cut the risk of progression or death by 54% vs EGFR-TKI comparator1

In metastatic EGFRm NSCLC

In a global phase 3 randomized study

First-line TAGRISSO: The only choice for median Overall Survival beyond 3 years3

OVERALL SURVIVAL IN THE PHASE 3 FLAURA STUDY

TAGRISSO Overall Survival (OS) in Phase 3 FLAURA Clinical Trial TAGRISSO Overall Survival (OS) in Phase 3 FLAURA Clinical Trial

At 3 years, 54% of TAGRISSO patients and 44% of EGFR-TKI comparator patients were still alive

TAGRISSO is the only NCCN preferred first-line treatment option in metastatic EGFRm NSCLC TAGRISSO is the only NCCN preferred first-line treatment option in metastatic EGFRm NSCLC Osimertinib (TAGRISSO) is the only National Comprehensive Cancer Network® (NCCN®) preferred first-line therapy option in metastatic EGFRm NSCLC.4*
*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.

Durable responses in overall study population1

  • Nearly 8 of 10 patients had a tumor response to first-line TAGRISSO (ORR 77% [95% CI: 71, 82] vs 69% [95% CI: 63, 74] for EGFR-TKI comparator)
  • Median duration of response was 17.6 months (95% CI: 13.8, 22.0) for first-line TAGRISSO and 9.6 months (95% CI: 8.3, 11.1) for EGFR-TKI comparator

In metastatic EGFRm NSCLC

FIRST-LINE TAGRISSO:

Reduced risk of CNS progression by 52%5

Median CNS PFS not reached with first-line TAGRISSO (95% CI: 16.5, NC) vs 13.9 months (95% CI: 8.3, NC) for EGFR-TKI comparator

CNS PFS IN PATIENTS WITH CNS METASTASES AT BASELINE

TAGRISSO reduced risk of CNS progression by 52% TAGRISSO reduced risk of CNS progression by 52%

NC=could not be calculated

CNS response rates1

CNS ORR by BICR in patients with measurable CNS lesions at baseline1

18% of patients with measurable CNS metastases experienced CNS complete response with TAGRISSO 18% of patients with measurable CNS metastases experienced CNS complete response with TAGRISSO

Approximately 1 in 5 patients with measurable CNS metastases experienced CNS complete response with first-line TAGRISSO

FLAURA: A phase 3, double-blind, randomized trial1,2,6

TAGRISSO (osimertinib) FLAURA Clinical Study Design TAGRISSO (osimertinib) FLAURA Clinical Study Design

Crossover was allowed for patients in the EGFR-TKI comparator arm upon confirmed progression and EGFR T790M positivity

Primary endpoint: PFS based on investigator assessment (according to RECIST v1.1)

Secondary endpoints: Overall Survival, overall response rate, CNS PFS, and duration of response

  • The two endpoints of OS and CNS PFS were tested after the primary PFS analysis in a hierarchical procedure at the time of PFS analysis, following primary analysis§
Patients received either erlotinib or gefitinib as the sole comparator preselected by the trial site. All US patients in the comparator arm received erlotinib.2RECIST v1.1 assessment every 6 weeks (±1 week) until objective progressive disease. Every 12 weeks (±1 week) after 18 months.2

§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

Patient characteristics

FLAURA BASELINE DEMOGRAPHICS1,3

TAGRISSO FLAURA Patient Characteristics TAGRISSO FLAURA Patient Characteristics

||Includes extrathoracic metastases.Identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018. 2. 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]. 3. 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. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines©) for NSCLC V.7.2019. ©National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed August 30, 2019. 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. 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. 2018:36(33):3290-3297. 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 Expand

  • 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

  • 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

Indications

  • 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

  • TAGRISSO is indicated for the treatment of 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


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