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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 (PFS) in the ITT Population

DACOPLICE® demonstrated a statistically significant improvement in median PFS of 5.5 months versus gefitinib (per IRC review)2

     

Median PFS in the ITT population (per IRC review)2,*,†

  

Example


Adapted from Wu YL, et al. 2017.

ARCHER 1050: Baseline characteristics (ITT population)

Start strong with superior median PFS versus gefitinib1

DACOPLICE® met its primary outcome measure and demonstrated a significant improvement in median PFS versus gefitinib (per IRC review): 14.7 months versus 9.2 months.2

  • The subgroup analyses were not adjusted for multiple testing and were not adequately powered by study design1
     
  • Subgroup analyses of PFS per IRC review based on baseline characteristics were consistent with those from the primary analysis of PFS1

As a secondary outcome measure, DACOPLICE® demonstrated an investigator-assessed median PFS of 16.6 months versus 11.0 months with gefitinib (HR = 0.62 [95% CI, 0.50-0.78]; 2-sided P<0.0001).1

*Median duration of follow-up for PFS in the ITT population was 22.1 months (95% CI, 20.3-23.9).1
The primary outcome measure of ARCHER 1050 was PFS by blinded IRC review in the ITT population.1


CI, confidence interval; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; PFS, progression-free survival.

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.

     

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​​​​

Learn more


Dosing & Therapy Management

Start with proven first-line efficacy

Learn more


Safety Profile

ARCHER 1050 study reported the most common adverse events in patients

Review safety profile

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