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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 (ORR and DoR)*

DACOPLICE® extended the median DoR by 6.5 months versus gefitinib1

  

  

Adapted from Wu YL, et al. Lancet Oncol. 2017.

  

Improving median DoR versus gefitinib¹

  • 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 assessed3
     
  • DACOPLICE® demonstrated an ORR of 75% versus 72% with gefitinib (P = 0.4234, not statistically significant)1,†
     
  • In patients who responded, DACOPLICE® demonstrated a significant median DoR versus gefitinib, 14.8 months versus 8.3 months, respectively (P<0.0001)1

Maximum tumour change from baseline by BOR (ITT population)1,II

  



Adapted from Wu YL, et al. Lancet Oncol. 2017.


Each bar represents an individual patient’s maximum reduction in target lesion size, and dashed lines show cut-offs for progressive disease (≥20% increase) and partial response (≥30% reduction).1
*ORR and DoR were secondary outcome measures.1 
Two-sided Pearson’s χ2 test. Not statistically significant.1
Calculated using the Kaplan-Meier method from time of the first documented response until date of progression or the last RECIST assessment for patients who did not have disease progression.1
§Two-sided Cochran-Mantel-Haenszel test, stratified by EGFR mutation status at randomisation (exon 19 deletion vs. Leu858Arg mutation) and by race (Japanese vs. Chinese and other East Asian vs. non-Asian).
IIPer RECIST version 1.1, by IRC review. Indeterminate was defined as progression not documented within 12 weeks after start of treatment date and where none of the other categories were applicable (complete response, partial response, stable disease or progressive disease).1


BOR, best overall response; CI, confidence interval; DoR, duration of response; EGFR, epidermal growth factor receptor; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; ORR, objective response rate; OS, overall survival; RECIST, Response Evaluation Criteria in Solid Tumours.

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​​​​

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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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