Related Experiment Video

Updated: Feb 16, 2026

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
08:52

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids

Published on: November 22, 2021

4.7K

CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials

G Goss1, C-M Tsai2, F A Shepherd3

  • 1Division of Medical Oncology, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|January 3, 2018
PubMed
Abstract

Insights

Osimertinib shows significant efficacy in treating central nervous system (CNS) metastases in non-small-cell lung cancer (NSCLC) patients. The drug achieved a high disease control rate and objective response rate in patients with brain metastases.

Area of Science:

  • Oncology
  • Medical Research
  • Clinical Trials

Background:

  • Central nervous system (CNS) metastases are a frequent complication in non-small-cell lung cancer (NSCLC).
  • Osimertinib has demonstrated systemic effectiveness in NSCLC patients with CNS metastases.
  • Early evidence suggests Osimertinib's efficacy within the CNS.

Purpose of the Study:

  • To evaluate the efficacy of Osimertinib in patients with CNS metastases from NSCLC.
  • To present a subgroup analysis of CNS response using pooled data from two Phase II studies (AURA extension and AURA2).

Main Methods:

  • Patients with T790M-positive advanced NSCLC and stable, asymptomatic CNS metastases were treated with Osimertinib 80 mg once daily.
  • A total of 411 patients received Osimertinib; 50 patients with measurable CNS lesions were included in the CNS response evaluable set (cEFR).
  • Primary endpoint was CNS objective response rate (ORR); secondary endpoints included CNS duration of response, disease control rate (DCR), and progression-free survival (PFS).

Main Results:

  • The confirmed CNS ORR was 54% (27/50), and the CNS DCR was 92% (46/50).
  • CNS response was observed irrespective of prior brain radiotherapy.
  • Median CNS duration of response was not reached; 75% of patients remained in response at 9 months. Median CNS PFS was also not reached.

Conclusions:

  • Osimertinib demonstrated clinically meaningful efficacy against CNS metastases in NSCLC.
  • The drug achieved a high DCR and encouraging ORR.
  • The safety profile in patients with CNS metastases was consistent with the overall population.

More Related Videos

Exosomal miRNA Analysis in Non-small Cell Lung Cancer NSCLC Patients' Plasma Through qPCR: A Feasible Liquid Biopsy Tool08:49

Exosomal miRNA Analysis in Non-small Cell Lung Cancer NSCLC Patients' Plasma Through qPCR: A Feasible Liquid Biopsy Tool

Published on: May 27, 2016

11.7K
E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy06:28

E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

9.3K

Related Concept Videos

Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.6K
Positive Regulator Molecules01:45

Positive Regulator Molecules

To consistently produce healthy cells, the cell cycle—the process that generates daughter cells—must be precisely regulated.
136.6K
Data Reporting and Recording01:24

Data Reporting and Recording

Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
5.5K
Trial and Error and Algorithm01:12

Trial and Error and Algorithm

A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
435
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.1K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.9K