Tagrisso in first-line advanced and metastatic NSCLC EGFR+
Research type
Research Study
Full title
Prospective Cohort of Advanced and Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutations: Long-Term Survival and Other Outcomes After First-Line Osimertinib in the UK
IRAS ID
303417
Contact name
Sanjay Popat
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Patients with non-small cell lung cancer (NSCLC) have poor five-year survival outcomes and the spread of cancer (metastases) to the central nervous system (CNS) is a common complication with a very poor prognosis.
Epidermal growth factor receptor (EGFR) plays an important role in regulating the way our bodies cells survive, differentiate and migrate. EGFR is commonly expressed in patients with NSCLC and mutations in EGFR can play an important role in driving the pathology of lung cancer.
Osimertinib (Tagrisso) is developed by AstraZeneca (AZ) to irreversibly inhibit mutated EGFR with minimal activity against non-mutated EGFRs (also called wild-type EGFR). In a recent double-blind Phase 3 trial (FLAURA), osimertinib had significantly improved median progression-free survival (PFS) compared to gefitinib or erlotinib (18.9 months vs. 10.2 months respectively). Furthermore, CNS progression was observed in 17 patients (6%) treated with osimertinib and 42 (15%) in the standard EGFR-TKI group.
In September 2020, osimetinib was approved by the United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE).
This UK-based real world prospective study will follow patients treated with osimertinib in the first-line setting for at least 38 months after the start of treatment to determine long-term survival and treatment pathways after osimertinib initiation in the real world.Summary of study results:
In a UK study of 68 patients with advanced and metastatic non-small cell lung cancer (NSCLC) who had specific genetic changes (EGFR mutations), the long-term survival and outcomes after first-line treatment with osimertinib were assessed. Most of the patients were women (63%), and the average age at the time of diagnosis was around 67 years.
The average survival time for all patients was about 17.77 months. For a small group of 5 patients with less common genetic changes, the average survival was slightly lower at 15.54 months. Patients who had cancer spread to their brain (metastases) had an average survival of 17.28 months, while those without brain metastases lived longer, averaging 26.86 months.
The average time patients lived without their cancer getting worse (progression-free survival) was about 10.4 months. For the small group with uncommon mutations, this was 5.95 months. Among those with brain metastases, it was 5.52 months, compared to 16.15 months for those without brain metastases.
In a specific analysis similar to the Flaura trial, the average overall survival was 24.9 months.
This study highlights the differences in survival outcomes based on genetic mutations or the presence of brain metastases, and the need for personalized treatment approaches in these patients.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0279
Date of REC Opinion
16 Aug 2021
REC opinion
Favourable Opinion