European Multidisciplinary Conference in Thoracic Oncology (EMCTO), Lugano, Switzerland – Objective Response Rate (ORR) and Progression-Free Survival (PFS) from the phase IV gefitinib (IRESSA™) Follow Up Measure (IFUM) study has confirmed that gefitinib is an effective treatment for Caucasian patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC).
The data was presented at the European Multidisciplinary Conference in Thoracic Oncology (EMCTO) 2013 in Lugano, Switzerland.
Results showed that first-line therapy with gefitinib (n=106) resulted in an ORR of 70% (95% CI 61-78). The ORR seen in this EGFR mutation-positive Caucasian population is similar to that seen in the EGFR mutation-positive IPASS2 population, therefore gefitinib appears to be consistent in its efficacy in patients with EGFR mutation-positive NSCLC irrespective of whether they are Asian or Caucasian. The secondary efficacy endpoints of disease control rate (DCR; complete/partial response or stable disease ≥6 weeks) was 91% (95% C.I. 84 - 95), estimated median PFS was 9.7 months, based on 61 events and estimated median OS was 19 months, based on 29 events. The adverse event profile of gefitinib in this population was consistent with previous clinical experience and prescribing information.
Jean-Yves Douillard, MD, PhD, and principal investigator said: “Gefitinib pioneered targeted therapy for NSCLC patients, and these results confirm that gefitinib is effective in Caucasian patients with advanced NSCLC with EGFR mutations, irrespective of their ethnicity.”
IFUM, a Phase IV, open-label, multicentre, single arm study was conducted in 13 countries in Europe to characterise the efficacy, safety and tolerability of gefitinib in Caucasian patients with EGFR mutation-positive NSCLC. The primary endpoint was ORR (confirmed Complete Response or Partial Response) based on investigators assessment in patients treated with gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST).
Gefitinib was granted a full Marketing Authorisation Approval in Europe in June 2009 in patients with EGFR mutation-positive NSCLC. This ‘Follow Up Measure’ study was designed to better characterize the profile of gefitinib in the Caucasian patients with EGFR mutation positive NSCLC in the first line setting.
Gefitinib is a single once-daily oral tablet, is an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), which targets and blocks the activity of the EGFR-TK, an enzyme that regulates intracellular signaling pathways implicated in cancer cell proliferation and survival. Growth factor signaling has been identified as a key driver of tumor growth and spread in a wide range of cancers. Studies have shown that EGFR mutation positive NSCLC is particularly sensitive to gefitinib.
