Real-World Data Of Osimertinib In Patients With Pretreated Non-Small Cell Lung Cancer: A Retrospective Study

Yuxin Mu1, Puyuan Xing1, Xuezhi Hao1

  • 1National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.

Abstract

Insights

Osimertinib demonstrated significant efficacy in pretreated non-small-cell lung cancer (NSCLC) patients with EGFR T790M mutations. The drug showed a high response rate and manageable side effects in this real-world setting.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Non-small-cell lung cancer (NSCLC) remains a leading cause of cancer-related deaths worldwide.
  • Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have revolutionized NSCLC treatment.
  • Acquired resistance to first- and second-generation EGFR-TKIs, often mediated by the T790M mutation, presents a significant clinical challenge.

Purpose of the Study:

  • To evaluate the real-world efficacy and safety of osimertinib in patients with pretreated advanced NSCLC.
  • To assess the treatment outcomes in patients with EGFR T790M resistance mutations after prior EGFR-TKI or chemotherapy treatments.

Main Methods:

  • A retrospective analysis was conducted on 94 patients with advanced NSCLC who received osimertinib post-progression on prior therapies.
  • Data collected included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), and safety profiles.
  • Subgroup analyses were performed, including stratification by T790M mutation status and specific EGFR mutations (exon19del, L858R), as well as patients with central nervous system metastases.

Main Results:

  • The overall objective response rate (ORR) was 47.3% and the disease control rate (DCR) was 90.1% in evaluable patients (n=91).
  • Median progression-free survival (PFS) was 8.6 months in the overall population, with longer PFS observed in patients with detectable T790M mutations (8.6 months) compared to those without (3.2 months).
  • Median PFS was significantly longer for T790M-positive patients with exon19del compared to those with L858R (17.9 months vs 7.3 months; P<0.001). Intracranial time to progression was not reached in patients with CNS metastases.

Conclusions:

  • Osimertinib demonstrates high activity and a manageable safety profile in pretreated advanced NSCLC patients, particularly those harboring the EGFR T790M mutation.
  • The real-world data support the efficacy of osimertinib in a diverse NSCLC patient population, including those with central nervous system involvement.
  • Osimertinib represents a valuable therapeutic option for patients who have progressed on prior EGFR-TKI therapies.