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TAGRISSO has demonstrated efficacy in PFS and ORR compared to doublet chemotherapy

TAGRISSO provided an impressive 10.1 months of median PFS compared to 4.4 months with doublet chemotherapy1

AURA3 study design

Median PFS was more than twice as long with TAGRISSO than with doublet chemotherapy*

  • 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 chemotherapy1
Progression-Free Survival Progression-Free Survival
  • At 6 months, 69% (95% CI: 63–74) of patients taking TAGRISSO were alive and progression free compared to 37% (95% CI: 29–45) of those receiving doublet chemotherapy2
  • At 12 months, the proportions were 44% (95% CI: 37–51) and 10% (95% CI: 5–17), respectively2

*As determined by investigator assessment (IA).

SELECT SAFETY INFORMATION

  • 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
  • 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

CNS Efficacy

SEE THE RESULTS BELOW

Subgroup results in a prespecified exploratory endpoint

Reduction in relative risk of progression (HR <0.50) was seen across subgroups: brain metastases, mutation status, ethnicity, gender, age, or smoking status12

Results Across Subgroups Results Across Subgroups Results Across Subgroups

NC=could not be calculated.

 

TAGRISSO demonstrated double the response rate compared to doublet chemotherapy1

6 of 10 patients had a response in the TAGRISSO arm compared to 3 of 10 in the doublet chemotherapy arm1

Confirmed Objective Response Rate of TAGRISSO Confirmed Objective Response Rate of TAGRISSO

*As determined by investigator assessment (IA).

Tumor response

Higher response rate at first scan compared to doublet chemotherapy

  • At the time of first scan (≤6 weeks), 82% of patients in the TAGRISSO arm showed a response compared to 66% of patients in the doublet chemotherapy arm1,2

Longer duration of response with TAGRISSO

Rapid and Durable Tumor Response Rapid and Durable Tumor Response

*As determined by investigator assessment (IA).

 

CNS efficacy with TAGRISSO in AURA3

  • At initiation, 54% of patients had extra-thoracic visceral metastases, including 34% with central nervous system (CNS) metastases (including 11% with measurable CNS metastases) and 23% with liver metastases. Forty-two percent (42%) of patients had metastatic bone disease1
  • 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 scan1
CNS Efficacy with TAGRISSO in AURA3 CNS Efficacy with TAGRISSO in AURA3

CNS ORR based on confirmed responses.

Additional CNS efficacy results2

Additional CNS Efficacy Results Additional CNS Efficacy Results

NR=not reached.

†Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event.

 

Study design of the Phase III head-to-head study1

In a Phase III head-to-head clinical trial, TAGRISSO was compared to doublet chemotherapy1

  • AURA3 was a Phase III, open-label, randomized study of TAGRISSO vs platinum-based doublet chemotherapy in patients with metastatic NSCLC whose disease had progressed with previous EGFR TKI therapy and whose tumors harbored the EGFR T790M mutation
Study Design of the Phase III Head-to-Head Study Study Design of the Phase III Head-to-Head Study

Endpoints

Primary: Progression-free survival (PFS)

Secondary: Objective response rate (ORR), duration of response (DoR) and overall survival (OS)

Inclusion criteria1

  • Metastatic NSCLC, with documentation of disease progression following first-line EGFR TKI treatment without any further treatment
  • Eligible to receive the selected platinum-based doublet chemotherapy regimen
  • Central laboratory confirmation of EGFR T790M mutation status
  • WHO performance status of 0–1
  • Stable asymptomatic CNS metastases allowed

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

Baseline demographics1

AURA3 Baseline Demographics AURA3 Baseline Demographics