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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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Dosing & Therapy ManagementDosing & Therapy ManagementDosageDose ModificationsProactive Management of Adverse EventsEfficacy Maintained After Dose ReductionSafety ProfileSupport & Services Support & Services Prescribing Information​​​​​​​Downloadable ResourcesEvents & WebinarsVideosLatest ArticlesExplore materialsExplore Videos

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 Maintained After Dose Reduction

Overview

  

Efficacy was maintained in patients whose dose was reduced
 

This was a post hoc exploratory analysis. Therefore, the results of this analysis cannot be used to suggest potential increased efficacy in patients whose dose was reduced.4

All patients in the Phase III study received a starting dose of 45 mg QD and efficacy comparisons of patients by their lowest dose on study (30 mg QD, 15 mg QD) are not likely to reflect the efficacy for these patients had they started with 30 mg QD or 15 mg QD.1,4

  

Adapted from Corral J, et al. Future Oncol. 2019.


Dose reductions occurred in 66% of patients treated with DACOPLICE®.1


In the ITT population


Dose reduction of DACOPLICE® did not compromise OS in the ITT population5

  • Dose reduction of DACOPLICE® did not compromise efficacy in the ITT population5
      
  • OS benefit was maintained in patients who had dose reduction versus all DACOPLICE® patients: 42.5 months versus 34.1 months, (HR = 0.554 [95% CI, 0.420-0.730])5,*
OS in all patients on DACOPLICE® versus those who had a dose reduction5,*



Adapted from Mok TS, et al. Presented at ESMO. 2019.

  

Dose reductions occurred in 66% of patients treated with DACOPLICE®.1

  

In the Asian population

  

In the Asian population, dose reduction of DACOPLICE® did not compromise the OS5

  • Dose reduction of DACOPLICE® does not compromise the OS in the Asian population5
     
  • The OS benefit was maintained in Asian patients who had dose reduction versus all Asian patients taking DACOPLICE®: NR versus 37.7 months (HR = 0.543 [95% CI, 0.393-0.750])5,*,†

OS in all patients on DACOPLICE® versus those who had a dose reduction5,*

  


Adapted from Mok TS, et al. Presented at ESMO. 2019.
 


*This was a post hoc exploratory analysis. Therefore, the results of this analysis cannot be used to suggest potential increased efficacy in patients whose dose was reduced.4

Unstratified analysis.5

CI, confidence interval; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; NR, not reached; OS, overall survival; PFS, progression-free survival; QD, once daily.

     

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.Corral J, Mok TS, Nakagawa K, et al. Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive non-small-cell lung cancer. Future Oncol. 2019;15:2795-2805.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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Dosing & Therapy Management


Mechanism of Action

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

Learn more


Clinical Efficacy

First-line use of DACOPLICE® was studied in a Phase III, head-to-head trial with gefitinib

Review efficacy profile


Safety Profile

ARCHER 1050 study reported the most common adverse events in patients

Review safety profile

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