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Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
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Osimertinib for Previously Treated Patients With Advanced EGFR T790M Mutation-Positive NSCLC: Tolerability and

Edgardo S Santos1, Barry Kaplan2, Eli Kirshner3

  • 1Lynn Cancer Institute, Boca Raton, FL, USA. esantos@brrh.com.

Oncology and Therapy
|July 24, 2020
PubMed
Summary

Osimertinib was well-tolerated in the US Expanded Access Program for EGFR T790M-positive non-small cell lung cancer patients. Most patients successfully transitioned to commercial osimertinib post-FDA approval, showing good tolerability across age groups.

Keywords:
Compassionate useEGFREGFR-TKINon-small cell lung cancerOsimertinib

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Area of Science:

  • Oncology
  • Pharmacology

Background:

  • The US Expanded Access Program (EAP) provided early access to osimertinib for advanced/metastatic EGFR T790M-positive non-small cell lung cancer (NSCLC) patients.
  • This program offered treatment before US Food and Drug Administration (FDA) approval for patients progressing on EGFR tyrosine kinase inhibitors (TKIs).

Purpose of the Study:

  • To report patient demographics, safety, and tolerability of osimertinib within the EAP.
  • To evaluate the diagnostic methods employed for T790M mutation testing in this patient cohort.

Main Methods:

  • Adult patients with EGFR T790M-positive NSCLC after prior EGFR-TKI therapy were enrolled.
  • Treatment involved 80 mg osimertinib once daily until dose modification, discontinuation, or EAP completion post-FDA approval.
  • Various testing methods were permitted for T790M detection.

Main Results:

  • 248 patients from 25 US centers participated; 96% maintained the starting dose.
  • 83% of patients completed the EAP and transitioned to commercial osimertinib, including those aged 75 years and older.
  • Serious adverse events (2%) were infrequent and primarily observed in older patients; common T790M testing included PCR (47%) and next-generation sequencing (33%).

Conclusions:

  • Osimertinib demonstrated good tolerability and efficacy in a real-world setting for EGFR T790M-positive NSCLC.
  • The majority of patients, including the elderly, transitioned to commercial osimertinib, indicating successful program outcomes.
  • The EAP highlighted an increasing use of minimally invasive T790M testing methods.