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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

Safety

DACOPLICE®-related adverse events1


In the ARCHER 1050 study, the most commonly reported adverse events (of any grade) in patients given DACOPLICE® were1:

Diarrhoea* (198 [87%]), paronychia (140 [62%]), dermatitis acneiform (111 [49%]) and stomatitis (99 [44%]).

The most commonly reported adverse events (of any grade) in patients given gefitinib were1:

Diarrhoea (125 [56%]), alanine aminotransferase increase (88 [39%]) and aspartate aminotransferase increase (81 [36%]).

 

Adverse events occurring in ≥10% of DACOPLICE®-treated patients in the ARCHER 1050 study (n=227)1

     

Adapted from Wu YL, et al. 2017.


DACOPLICE®-related serious adverse events1
 

Serious adverse reactions
 

The most commonly reported Grade 3 and 4 adverse events were dermatitis acneiform (31 [14%] of 227 patients given DACOPLICE® vs. 0 of 224 patients given gefitinib), diarrhoea (19 [8%] vs. 2 [1%]) and raised alanine aminotransferase levels (2 [1%] vs. 19 [8%]).1

Treatment-related serious adverse events were reported in 21 (9%) patients given DACOPLICE® and in 10 (4%) patients given gefitinib. Treatment-related serious adverse events were gastrointestinal disorders (10 [4%] patients given DACOPLICE® vs. 0 given gefitinib), skin and subcutaneous disorders (3 [1%] vs. 0), respiratory disorders (2 [1%] vs. 3 [1%]), hepatobiliary disorders (3 [1%] vs. 2 [1%]), elevated liver enzymes (0 vs. 3 [1%]), metabolism and nutrition disorders (2 [1%] vs. 0), infections (2 [1%] vs. 1 [<1%]), keratitis (1 [<1%] vs. 0), acute kidney injury (1 [<1%] vs. 0) and chronic myeloid leukemia (1 [<1%] vs. 0).1

Permanent discontinuation because of adverse events related to study drug occurred in 22 (10%) of 227 patients in the DACOPLICE® group and in 15 (7%) of 224 patients in the gefitinib group. The most frequent of these in the DACOPLICE® group were skin and subcutaneous tissue disorders (n=7), gastrointestinal disorders (n=4) and ILD or pneumonitis (n=3), whereas in the gefitinib group, they were alanine aminotransferase or aspartate aminotransferase increase (n=6) and ILD or pneumonitis (n=3).1

Dose reductions occurred in 150 (66%) of 227 patients in the DACOPLICE® group; 87 (38%) patients received a lowest dose of 30 mg/day and 63 (28%) patients received a lowest dose of 15 mg/day.1

Two treatment-related deaths occurred in the DACOPLICE® group (1 related to untreated diarrhoea and 1 to untreated cholelithiases/liver disease) and 1 in the gefitinib group (related to sigmoid colon diverticulitis/rupture complicated by pneumonia).1

  

  

*Fatal events were reported.1
For special warnings and precautions for use, please see the DACOPLICE® prescribing information.3


ALT, alanine aminotransferase; ARCHER, Adolescent Rural Cohort on Hormones, Education, Environment, Health and Relationships; AST, aspartate aminotransferase; ILD, interstitial lung disease.

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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Safety Profile


Mechanism of Action

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

Learn more


Guidelines

DACOPLICE® is recommended by clinical practice guidelines

Learn more


Dosing & Therapy Management

Start with proven first-line efficacy

Learn more


Clinical Efficacy

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

Review efficacy profile

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