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Sequencing With Osimertinib in EGFR-Mutated NSCLC

Insights From: Sai-Hong Ignatius Ou, MD, PhD, University of California, Irvine School of Medicine
Published: Tuesday, Jun 04, 2019



Transcript: 

Sai-Hong Ignatius Ou, MD, PhD: In the FLAURA study, osimertinib is efficacious in all the subgroup analyses. I would not stratify patients based on CNS [central nervous system] metastases or based on other type of mutations to decide which TKI [tyrosine kinase inhibitor] to use. I think osimertinib is good for all of these patients, so I would use osimertinib up front. The sequencing strategy depends on the T790M mutations, as Lyudmila Bazhenova, MD talked about in the symposium. Forty percent of the patients may not develop T790M mutations, and they will have to go through a different treatment modality. For sequencing, it’s good if you go from the one sequence to the T790M, but, in reality, we cannot predict which patients will develop the T790M mutation. So, I would use osimertinib up front. The treatment of osimertinib will be dependent on the biopsy results, and I think that’s a strategy I’ll use.

Real-world data from outside the United States are a lot of times impacted by what agent is approved in the countries where the real-world data are reported. In some countries, osimertinib is not approved as a first-line treatment for EGFR-mutated lung cancer. They are not reimbursed by the government. The data may look good if you sequence from the first-generation to the third-generation. The real-world data are impacted by the availability of the drugs, either depending on approval or government reimbursement. We have to be very cautious about interpreting the data. A lot of times patients may not be able to get scans on a regular basis, and the centering of the progression may be different, and also how the data are captured. Whether they are through a good database, such as a Flatiron Health database, or just a superficial extraction of data by the investigator, it’s important to know. Despite the FDA, I think insistence to get some real-world data cannot supplant the randomized phase III studies.

Transcript Edited for Clarity
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Transcript: 

Sai-Hong Ignatius Ou, MD, PhD: In the FLAURA study, osimertinib is efficacious in all the subgroup analyses. I would not stratify patients based on CNS [central nervous system] metastases or based on other type of mutations to decide which TKI [tyrosine kinase inhibitor] to use. I think osimertinib is good for all of these patients, so I would use osimertinib up front. The sequencing strategy depends on the T790M mutations, as Lyudmila Bazhenova, MD talked about in the symposium. Forty percent of the patients may not develop T790M mutations, and they will have to go through a different treatment modality. For sequencing, it’s good if you go from the one sequence to the T790M, but, in reality, we cannot predict which patients will develop the T790M mutation. So, I would use osimertinib up front. The treatment of osimertinib will be dependent on the biopsy results, and I think that’s a strategy I’ll use.

Real-world data from outside the United States are a lot of times impacted by what agent is approved in the countries where the real-world data are reported. In some countries, osimertinib is not approved as a first-line treatment for EGFR-mutated lung cancer. They are not reimbursed by the government. The data may look good if you sequence from the first-generation to the third-generation. The real-world data are impacted by the availability of the drugs, either depending on approval or government reimbursement. We have to be very cautious about interpreting the data. A lot of times patients may not be able to get scans on a regular basis, and the centering of the progression may be different, and also how the data are captured. Whether they are through a good database, such as a Flatiron Health database, or just a superficial extraction of data by the investigator, it’s important to know. Despite the FDA, I think insistence to get some real-world data cannot supplant the randomized phase III studies.

Transcript Edited for Clarity
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