For patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, at progression on or after TKI therapy

TAGRISSO has demonstrated efficacy in PFS and ORR compared to doublet chemotherapy1*

TAGRISSO PFS TAGRISSO PFS
  • In a clinical study, the median PFS for patients receiving TAGRISSO was 10.1 months (95% CI: 8.3, 12.3), compared to 4.4 months (95% CI: 4.2, 5.6) for those receiving doublet chemotherapy

*As determined by investigator assessment (IA).

Prespecified subgroup results2*

Reduction in relative risk of progression (HR <0.50) was seen across subgroups: brain metastases, mutation status, ethnicity, gender, age, or smoking status.

*Exploratory analysis.

CNS results with TAGRISSO in AURA31

CNS OBJECTIVE RESPONSE RATE BASED ON CONFIRMED RESPONSES

CNS efficacy with TAGRISSO vs chemotherapy CNS efficacy with TAGRISSO vs chemotherapy
  • At initiation, 54% of patients had extra-thoracic visceral metastases, including 34% with CNS metastases (including 11% with measurable CNS metastases) and 23% with liver metastases. Forty-two percent (42%) of patients had metastatic bone disease
  • A BICR assessment of CNS efficacy by RECIST v1.1 was conducted in the subgroup of 46/419 (11%) patients identified to have measurable CNS lesions on a baseline brain scan

Study design of the phase 3 head-to-head study1

Study design of AURA3 clinical study Study design of AURA3 clinical study
  • Crossover was allowed in the chemotherapy arm for patients who could receive TAGRISSO upon investigator and central confirmation of progression

Primary endpoint: progression-free survival (PFS)

Secondary endpoints: overall response rate (ORR), duration of response (DOR), and overall survival (OS)

*Pemetrexed 500 mg/m2 with carboplatin (AUC5) or pemetrexed 500 mg/m2 with cisplatin 75 mg/m2 for up to 6 cycles.

View full AURA3 study design on ClinicalTrials.gov

Baseline demographics1

Demographics of patients who participated in AURA3 clinical trial Demographics of patients who participated in AURA3 clinical trial

TAGRISSO safety profile1

Adverse reactions occurring in ≥10% (for all grades) of TAGRISSO- and doublet chemotherapy-treated patients*

  • No Grade 4 events were reported
  • No single serious adverse reaction was reported in 2% or more of patients treated with TAGRISSO
Adverse reactions reported for TAGRISSO in AURA3 Clinical Trial Adverse reactions reported for TAGRISSO in AURA3 Clinical Trial Adverse reactions reported for TAGRISSO in AURA3 Clinical Trial

In patients treated with TAGRISSO once daily in AURA3, 2.9% had a dose reduction.

*NCI CTCAE v4.0.

No Grade 4 events were reported.

Includes rash, rash generalized, rash erythematous, rash macular, rash maculopapular, rash papular, rash pustular, erythema, folliculitis, acne, dermatitis, and acneiform dermatitis.

§Includes dry skin, eczema, skin fissures, xerosis.

||Includes nail disorders, nail bed disorders, nail bed inflammation, nail bed tenderness, nail discoloration, nail dystrophy, nail infection, nail ridging, nail toxicity, onychoclasis, onycholysis, onychomadesis, paronychia.

Includes pruritus, pruritus generalized, eyelid pruritus.

#Includes fatigue, asthenia.

Common laboratory abnormalities (≥20% for all grades) in AURA31

Laboratory abnormalities found in AURA3 Clinical Trial Laboratory abnormalities found in AURA3 Clinical Trial

NA=not applicable.

aNCI CTCAE v4.0.

bEach test incidence, except for hyperglycemia, is based on the number of patients who had both baseline and at least one on-study laboratory measurement available (TAGRISSO 279, EGFR TKI comparator 131).

cHyperglycemia is based on the number of patients who had both baseline and at least one on-study laboratory measurement available (TAGRISSO 270, Chemotherapy 5: fasting glucose was not a protocol requirement for patients in the chemotherapy arm).

When patients progress on a first- or second-generation EGFR TKI, test for EGFR T790M resistance mutation

TAGRISSO has the only FDA-approved, clinically validated companion diagnostic test for the EGFR T790M mutation that uses either tissue or plasma.1

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.3

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.3

As patients progress on an EGFR TKI, test for EGFR T790M resistance mutation to determine if they should use TAGRISSO as a second-line therapy As patients progress on an EGFR TKI, test for EGFR T790M resistance mutation to determine if they should use TAGRISSO as a second-line therapy

Reevaluate the feasibility of tissue testing with negative plasma results1,3

  • Select patients for the treatment of metastatic EGFR T790M mutation-positive NSCLC with TAGRISSO following progression on or after EGFR TKI therapy based on the presence of an EGFR T790M mutation in tumor or plasma specimens
  • Testing for the presence of the T790M mutation in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained
  • If this mutation is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing

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.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018. 2. Mok TS, Wu YL, Ahn MJ, et al. Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. N Engl J Med. 2017;376:629-640. 3. cobas® EGFR Mutation Test v2 [package insert]. Indianapolis, IN: Roche Molecular Systems, Inc.; 2016.

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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