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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

ARCHER 1050: Study Design1

First-line use of DACOPLICE® was studied in a multicentre, multinational, randomised, open-label, Phase III, head-to-head trial with gefitinib.1

     

Example

     

Adapted from Wu YL, et al. 2017.

 

ARCHER 1050: Baseline characteristics (ITT population)1

Example

 

    

Adapted from Wu YL, et al. 2017.

   

Data are median (IQR) or n (%).1

    

*EGFR mutation status was prospectively determined by local laboratory and commercially available tests (e.g. therascreen® EGFR RGQ PCR at accredited laboratories).1
Newly diagnosed with Stage IV at the time of study entry.1
EGFR mutations (at randomisation) were identified from tumour specimens.1
§At randomisation, 2 patients in the gefitinib group (and none in the DACOPLICE® group) had the Thr790 Met mutation. At randomisation, 2 patients in the DACOPLICE® group (and none in the gefitinib group) had the Thr790 Met mutation.


ARCHER, Adolescent Rural Cohort on Hormones, Education, Environment, Health and Relationships; CNS, central nervous system; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; IQR, interquartile range; IRC, independent radiological central; ITT, intention-to-treat; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PCR, polymerase chain reaction; PFS, progression-free survival; PO, per orem (oral); PRO, patient-reported outcome; RECIST, Response Evaluation Criteria in Solid Tumours; RGQ, rotor-gene q; RMST, restricted mean survival time; TKI, tyrosine kinase inhibitor; TTF, time to treatment failure.

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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