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Osimertinib as first-line therapy in advanced NSCLC: a profile of its use

Lesley J Scott1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754 Auckland, New Zealand.

Drugs & Therapy Perspectives : for Rational Drug Selection and Use
|January 12, 2019
PubMed

Insights

Osimertinib, a third-generation EGFR TKI, significantly improves progression-free survival in advanced non-small cell lung cancer (NSCLC) patients with EGFR mutations compared to older TKIs.

Area of Science:

  • Oncology
  • Pharmacology
  • Medical Research

Background:

  • Acquired resistance to first-generation EGFR TKIs in advanced non-small cell lung cancer (NSCLC) is often mediated by the T790M mutation.
  • Third-generation EGFR TKIs offer targeted inhibition of specific mutations, including T790M, and wild-type EGFR.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of osimertinib as a first-line treatment for advanced NSCLC with activating EGFR mutations.
  • To compare osimertinib's progression-free survival (PFS) against standard-of-care first-generation EGFR TKIs.

Main Methods:

  • A clinical trial comparing osimertinib to first-generation EGFR TKIs (erlotinib or gefitinib) in patients with advanced NSCLC and EGFR activating mutations.
  • Assessment of progression-free survival (PFS) as the primary endpoint.
  • Analysis of PFS across subgroups, including those with and without CNS metastases and varying EGFR mutation types.

Main Results:

  • Osimertinib demonstrated a significant prolongation of median PFS compared to standard first-generation EGFR TKIs.
  • PFS benefit with osimertinib was observed early, with curve separation by 6 weeks.
  • Osimertinib showed consistent PFS benefits across all prespecified subgroups, regardless of baseline EGFR mutation or CNS metastasis status.

Conclusions:

  • Osimertinib represents a superior first-line treatment option for advanced NSCLC patients with EGFR activating mutations, significantly improving PFS.
  • The drug's efficacy extends to patients with CNS metastases and various EGFR mutation profiles.
  • Osimertinib presents a manageable tolerability profile, supporting its clinical utility.

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