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​​​​​​​Downloadable ResourcesAboutAboutMechanism of ActionGuidelinesClinical Efficacy  Clinical Efficacy ARCHER 1050: Study DesignEfficacy (PFS) in the ITT PopulationEfficacy (PFS) in the Asian PopulationEfficacy (ORR and DoR)Efficacy (mOS)

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Start With Proven First-line Efficacy1-3
 

Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.3

Efficacy (mOS)

OS in the ITT population

  

DACOPLICE® demonstrated an mOS of 34.1 months in the ARCHER 1050 study2,*

  

mOS in the ITT population2,*,†

 

  

Adapted from Mok TS, et al. Presented at ESMO. 2019.4

  

According to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached. Therefore, the statistical significance of OS improvement could not be formally assessed.3

  

In a descriptive analysis, DACOPLICE® demonstrated an mOS of 34.1 months versus 27 months with gefitinib (HR = 0.748 [95% CI, 0.591-0.947]).2

  

OS in the Asian population

 

DACOPLICE® is the first EGFR TKI to demonstrate a survival benefit in Asian patients1

 

OS in the Asian population2,‡

 

 

Adapted from Mok TS, et al. Presented at ESMO. 2019.4

 

In a subgroup analysis, DACOPLICE® demonstrated an improvement in mOS of 8.6 months versus gefitinib in Asian patients: 37.7 months versus 29.1 months.2,‡

  

Subgroup analysis

  

DACOPLICE® demonstrated a significant improvement in OS in key subgroups, including Asian and exon 21 L858R mutation patient populations2,3

  

Subgroup analysis of OS (ITT population)2,‡

  

  

Adapted from Mok TS, et al. Presented at ESMO. 2019.4

  

In the ARCHER 1050 study, DACOPLICE® demonstrated a significant improvement in OS across multiple populations:

  • ITT population2,§
  • Asian population2
  • Patients with the EGFR exon 21 L858R substitution1-3
 

OS in the exon 21 substitution population
 

Patients with EGFR exon 21 L858R substitution experience proven results with DACOPLICE®1-3

  

OS in the exon 21 L858R substitution population2,‡,¶,**

  

  

Adapted from Mok TS, et al. Presented at ESMO. 2019.4

  

DACOPLICE® has proven clinical activity against the common EGFR exon 21 L858R substitutions.1-3

  

In a subgroup analysis, DACOPLICE® demonstrated a significant improvement in OS versus gefitinib in patients with exon 21 L858R substitution.2,‡,¶

  

DACOPLICE® demonstrated a prolongation in mOS of 9.2 months versus gefitinib in patients with exon 21 L858R substitution: 32.5 months versus 23.2 months.2,‡,¶

  

OS in the exon 19 deletion population

  

DACOPLICE® confers benefit in EGFR-mutant positive patients with exon 19 deletion versus gefitinib1

  

OS in the exon 19 deletion population2,‡,¶,**

  

Adapted from Mok TS, et al. Presented at ESMO. 2019.4

DACOPLICE® has proven clinical activity against the common EGFR exon 19 deletion.1-3

In a subgroup analysis, DACOPLICE® conferred a benefit in OS versus gefitinib in patients with exon 19 deletion: 36.7 months versus 30.8 months (HR = 0.847** [95% CI, 0.618-1.161]; P = 0.3021).4,‡,¶,**

 


*OS was a secondary outcome measure in the ARCHER 1050 study.1,2 
Data cut-off: 13 May 2019. Median follow-up time for the OS analysis was 47.9 months.4
The subgroup analyses were not adjusted for multiple testing and were not adequately powered by study design. Subgroup analyses of PFS per IRC review and OS based on pre-specified baseline characteristics were consistent with those from the primary analysis of PFS and OS.1
§According to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached. Therefore, the statistical significance of OS improvement could not be formally assessed.3
||P interaction.4
OS is based on an ad hoc analysis with extended follow-up of median of 47.9 months approximately 2 years from the predesignated final analysis. The most recent cut-off of 13 May 2019.1
**Unstratified analysis.4


ARCHER, Adolescent Rural Cohort on Hormones, Education, Environment, Health and Relationships; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; EGFR, epidermal growth factor receptor; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; mOS, median overall survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.
 

References:

Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-1466.Mok TS, Cheng Y, Zhou X, et al. Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations. J Clin Oncol. 2018;36(22):2244-2250.Dacoplice. Local product document. Pfizer; 2021. Version LPDDAC042021.Mok TS, Cheng Y, Zhou X, et al. Updated overall survival (OS) from extended follow up in ARCHER 1050: A randomized phase III study comparing dacomitinib with gefitinib as first line therapy for patients (pts) with EGFR mutations. Orally Presented at ESMO Asia Congress 2019, Singapore, 22-24 November 2019; Singapore. Accessed April 25, 2022.

     

Please click the Prescribing Information link to view the safety and adverse events information of DACOPLICE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

     

PP-DAC-IND-0147 June 2022

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Clinical Efficacy
Mechanism of Action

DACOPLICE® is a second-generation EGFR TKI​​​​

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Dosing & Therapy Management

Start with proven first-line efficacy

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Safety Profile

ARCHER 1050 study reported the most common adverse events in patients

Review safety profile

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