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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 (PFS) in the Asian Population

In the Asian population, DACOPLICE® demonstrated a statistically significant improvement in PFS versus gefitinib (per IRC review)4

  

Median PFS in the ITT population (per IRC review)4,*,†

  

  

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


In a subgroup analysis, DACOPLICE® demonstrated an improvement in median PFS versus gefitinib in Asian patients: 16.5 months versus 9.3 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
Unstratified analysis.1

 

CI, confidence interval; HR, hazard ratio; IRC, independent radiological central; OS, overall survival; 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.Mok TS, Cheng Y, Zhou X, et al. Safety and efficacy of dacomitinib for EGFR + NSCLC in the subgroup of Asian patients from ARCHER 1050. Poster 651. 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​​​​

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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