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Updated: Sep 7, 2025

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
Osimertinib: A Review in Completely Resected, Early-Stage, EGFR Mutation-Positive NSCLC
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com.
Abstract:
Osimertinib (TAGRISSO®) is an orally administered, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is approved for the adjuvant treatment of adults with completely resected, stage IB-IIIA, EGFR sensitizing mutation (exon 19 deletion or exon 21 [L858R] substitution)-positive non-small cell lung cancer (NSCLC). In the pivotal ADAURA trial in adults with completely resected, early-stage, EGFR mutation-positive (EGFRm+) NSCLC, osimertinib adjuvant therapy significantly prolonged disease-free survival (DFS) compared with placebo in the overall population of patients with stage IB-IIIA disease, as well as in the primary population of patients with stage II-IIIA disease. A DFS benefit of osimertinib was seen irrespective of whether or not patients received prior adjuvant chemotherapy. Overall survival (OS) data were very immature at the time of the analysis of DFS, and more mature OS data are awaited with interest. Osimertinib adjuvant therapy did not adversely affect health-related quality of life and was generally well tolerated, with a manageable safety profile and no new safety signals identified. Based on the available evidence, osimertinib is thus an appropriate targeted option for the adjuvant treatment of adults with completely resected, stage IB-IIIA, EGFRm+ NSCLC.
Insights
Osimertinib significantly improves disease-free survival in early-stage, EGFR-mutated non-small cell lung cancer. This targeted therapy is well-tolerated and maintains quality of life for patients receiving adjuvant treatment.
Area of Science:
- Oncology
- Pharmacology
- Medical Research
Background:
- Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality worldwide.
- Epidermal growth factor receptor (EGFR) mutations are key drivers in a subset of NSCLC patients.
- Adjuvant therapy aims to eliminate residual disease and prevent recurrence after surgery.
Purpose of the Study:
- To evaluate the efficacy and safety of osimertinib as adjuvant treatment for early-stage, EGFR-mutated NSCLC.
- To assess the impact of osimertinib on disease-free survival (DFS) and overall survival (OS).
- To determine the effect of osimertinib on health-related quality of life.
Main Methods:
- The ADAURA trial was a pivotal study involving adult patients with resected, EGFRm+ NSCLC.
- Patients received either osimertinib or placebo as adjuvant therapy.
- Disease-free survival (DFS) was the primary endpoint, with overall survival (OS) as a key secondary endpoint.
Main Results:
- Osimertinib significantly prolonged DFS in patients with stage IB-IIIA EGFR-mutated NSCLC compared to placebo.
- The DFS benefit was observed across all stages (IB-IIIA) and was independent of prior adjuvant chemotherapy.
- Osimertinib demonstrated a manageable safety profile and did not negatively impact quality of life.
Conclusions:
- Osimertinib is an effective and well-tolerated targeted therapy for the adjuvant treatment of completely resected, early-stage, EGFR-mutated NSCLC.
- The drug offers a significant DFS advantage, establishing it as a crucial option in the adjuvant setting.
- Further mature overall survival data are anticipated with great interest.
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