Study Design

ARCHER 1050 trial design2,3

The first-line use of VIZIMPRO was studied in a multicenter, multinational, randomized, open-label, Phase 3, head-to-head trial with Iressa® (gefitinib)2

Patients were randomized (1:1) to receive VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225) orally once daily until disease progression or unacceptable toxicity occurred.

Patient population (N=452)

  • Unresectable metastatic NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy
  • ECOG performance status of 0 or 1
  • EGFR exon 19 deletion or exon 21 L858R substitution mutations
  • Patients were excluded if they had a history of interstitial lung disease (ILD), interstitial pneumonitis, or brain metastases

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam

  • Major efficacy outcome measure: Progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review per RECIST v1.13
  • Additional efficacy outcome measures: PFS (investigator assessed), overall response rate (ORR) and duration of response (DOR) (per IRC), and overall survival (OS)2,3
  • Stratification factors3:
    • EGFR mutation status (exon 19 deletion vs exon 21 L858R substitution mutation)
    • Region (Japanese vs mainland Chinese vs other East Asian vs non-East Asian)

Baseline patient characteristics

Baseline characteristics were balanced across both VIZIMPRO and gefitinib arms2,3

** This is an optional area where footnotes can live.

In ARCHER 1050, subsequent systemic therapies for patients who progressed included chemotherapy, T790M inhibitors, and other agents.4

​​​​​​​Iressa is a registered trademark of the AstraZeneca group of companies.
ECOG=Eastern Cooperative Oncology Group; PO=by mouth; QD=once a day; RECIST=Response Evaluation Criteria in Solid Tumors.


References:
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed June 3, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  2. 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.
  3. VIZIMPRO Prescribing Information. New York, NY: Pfizer Inc.
  4. 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.

Efficacy & Safety

  • Efficacy
  • Safety Profile
  • Study Design
View Support & Services

Dacomitinib (VIZIMPRO) is a National Comprehensive Cancer Network® (NCCN®) recommended treatment option1*

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend dacomitinib (VIZIMPRO) as one of the first-line options for sensitizing EGFR-positive metastatic NSCLC (Category 1)​​​​​​​1

Learn more

*The NCCN Guidelines® for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays.

There are no contraindications for VIZIMPRO

Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed.

Diarrhea: Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.

Dermatologic Adverse Reactions: Rash and exfoliative skin reactions occurred in patients treated with VIZIMPRO. Rash occurred in 78% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 rash was reported in 21% of patients. Exfoliative skin reactions of any severity were reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were reported in 1.8% of patients. Withhold VIZIMPRO for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse reaction until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of VIZIMPRO, initiate use of moisturizers and appropriate measures to limit sun exposure. Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids. Initiate oral antibiotics for Grade 2 or more severe dermatologic adverse reactions.

Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VIZIMPRO and for at least 17 days after the final dose.

Adverse Reactions: The most common (>20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%).

Drug Interactions: Concomitant use with a proton pump inhibitor (PPI) decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid the concomitant use of PPIs with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist. Concomitant use of VIZIMPRO increases the concentration of drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs. Avoid concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

Lactation: Because of the potential for serious adverse reactions in breastfed infants from VIZIMPRO, advise women not to breastfeed during treatment with VIZIMPRO and for at least 17 days after the last dose.

Geriatric: Exploratory analyses suggest a higher incidence of Grade 3/4 adverse reactions and more frequent dose interruptions and discontinuations for adverse reactions in patients 65 years or older.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. The recommended dose of VIZIMPRO has not been established for patients with severe hepatic impairment.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment. The recommended dose of VIZIMPRO has not been established for patients with severe renal impairment.

VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Please see Full Prescribing Information for VIZIMPRO.

Indication

VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Please see Full Prescribing Information for VIZIMPRO.