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Biomarker Testing Continues to Develop in NSCLC

Danielle Bucco
Published: Thursday, Dec 28, 2017

We do not need a lot of immunohistochemistry testing to tell us more about adenocarcinoma versus squamous cell carcinoma. We need to streamline this so that we can move forward and still have the appropriate tissue remaining to get these biomarkers.  

Can you discuss the role of osimertinib (Tagrisso) in EGFR-positive NSCLC and the impact this has on the treatment landscape?

There have been many advances recently and there are trials investigating targeted therapies in the EGFR setting. We are very excited to see the results of the FLAURA trial. That is the first-line utilization of osimertinib in patients with EGFR-mutated metastatic NSCLC. This trial is a phase III randomized trial including patients who had either exon 19 deletion or L858R mutation in EGFR. They had a performance status of 0 or 1 and could have brain metastases, but they needed to have stable disease from that perspective. The patients were randomized 1:1 to receive either osimertinib or another standard agent, erlotinib or gefitinib. They were assessed every 6 weeks with imaging with some crossover for the patients who progressed on the standard-of-care treatment. 

We saw an improvement in the primary endpoint, which was PFS. The hazard ratio was 0.46, resulting in a 54% reduction for progression or death when compared with standard of care. This is a tremendous reason to bring osimertinib to the first-line setting because it is currently FDA approved in the second-line setting for patients who developed or acquired the T790M mutation.

In the first-line setting, it was investigated in all patients with sensitizing mutations. Impressively, we could see that PFS was not altered whether the patient had CNS metastases at baseline. The hazard ratios were the same and there was less progression in the CNS for the patients who received osimertinib when compared to those who received erlotinib or gefitinib. 

What are some forward-looking thoughts on targeted therapies in NSCLC?

I hope that most [physicians] understand that there is a wealth of opportunity to treat patients with targeted therapy. In order to do that, you have to conduct the testing. We do not want to miss opportunities for patients to receive oral therapy that is well tolerated and results in better outcomes. We need to make sure that we are looking at our patients who are going to have these opportunities to receive these therapies.
Ramalingam S, Reungwetwattana T, Chewaskulyong B, et al. Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA. In: Proceedings from the 2017 ESMO Congress; September 9-12, 2017; Madrid, Spain. Abstract LBA2_PR.



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Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Leveraging Liquid Biopsies in Tumor Characterization for NSCLC TherapyJan 31, 20181.5
Oncology Best Practice™: Choosing Therapies for Patients with EGFR-Mutant Lung Cancers: More Options... More Decisions... Better OutcomesFeb 28, 20182.0
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