Study Design

ARCHER 1050 trial design
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
  • Major efficacy outcome measure: Progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review per RECIST v1.1
  • Additional efficacy outcome measures2: PFS (investigator assessed), overall response rate (ORR) and duration of response (DOR) (per IRC), and overall survival (OS)
  • Stratification factors:
    • 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
In ARCHER 1050, subsequent systemic therapies for patients who progressed included chemotherapy, T790M inhibitors, and other agents.3
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.5.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 7, 2019. 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. 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.