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Safety of osimertinib in EGFR-mutated non-small cell lung cancer

Laura Mezquita1, Andreea Varga2, David Planchard1

  • 1a Medical Oncology Department , Gustave Roussy , Villejuif , France.

Expert Opinion on Drug Safety
|November 21, 2018
PubMed
Abstract

Insights

Osimertinib, a targeted therapy for EGFR-mutated non-small cell lung cancer, shows improved efficacy and a manageable safety profile. It is now a recommended first-line treatment option for these patients.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Osimertinib is a third-generation EGFR tyrosine kinase inhibitor (TKI) targeting specific mutations.
  • It is designed to minimize exposure in EGFR-wild-type tissues, enhancing selectivity.
  • Its efficacy and safety profile have been evaluated in EGFR-mutated non-small cell lung cancer (NSCLC).

Purpose of the Study:

  • To describe the use of osimertinib in EGFR-mutated NSCLC patients.
  • To focus on the safety and tolerability of osimertinib based on supporting studies.
  • To provide an expert opinion on osimertinib's role in NSCLC treatment.

Main Methods:

  • Review of clinical studies supporting osimertinib's approval.
  • Analysis of efficacy, including central nervous system (CNS) activity.
  • Evaluation of safety and tolerability profiles compared to chemotherapy and other TKIs.

Main Results:

  • Osimertinib demonstrated superior efficacy and CNS activity compared to chemotherapy in pretreated T790M+ patients.
  • The FLAURA study showed improved progression-free survival with osimertinib versus other TKIs in untreated patients.
  • Osimertinib has a manageable safety profile, with a slightly higher but manageable rate of interstitial lung disease.

Conclusions:

  • Osimertinib is approved for T790M+ NSCLC and as first-line therapy for EGFR-mutated NSCLC.
  • It offers a favorable safety and tolerability profile, positioning it as a standard therapy.
  • Long-term survival data will further define optimal treatment strategies.
Keywords:
AZD9291EGFRNSCLCOsimertinibtyrosine kinase inhibitor

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