Suresh S. Ramalingam, MD
Osimertinib (Tagrisso), an EGFR tyrosine kinase inhibitor (TKI), is quickly emerging as a therapeutic option for patients with EGFR
-mutant non-small cell lung cancer (NSCLC) who develop the acquired resistance mutation T790M
, Suresh S. Ramalingam, MD, a professor in the Department of Hematology and Medical Oncology, Roberto C. Goizueta Distinguished Chair for Cancer Research, at Winship Cancer Institute at Emory University, and an investigator on both the AURA3 and FLAURA studies, discusses the major findings of AURA3 study and delves into the enthusiasm surrounding osimertinib’s first-line potential in the FLAURA trial.
OncLive: What are the updated findings with the AURA3 trial presented here in Vienna?
: Osimertinib is a third-generation EGFR inhibitor that has recently received accelerated approval from the FDA for treatment of patients with acquired resistance to an EGFR TKI. These are patients who developed the T790M
mutation, which happens in 50% to 60% of the patients who develop resistance to erlotinib (Tarceva), gefitinib (Iressa), or afatinib (Gilotrif).
What are the next steps following these results?
The AURA3 results reported here included the response rate, which was higher for osimertinib, and PFS. Patients were allowed to cross over from chemotherapy to osimertinib, so that would definitely affect the survival results. However, we will see the survival results mature in the upcoming months to 1 year or so.
We also learned that the adverse event profile of osimertinib was very favorable—with minimal grade 3 toxicities—which also lends this agent to combination approaches that can be developed from here onwards.
How about this agent’s potential in frontline, which is being explored in the FLAURA trial?
The other area that this agent is being developed is in the first-line setting for patients with EGFR
mutation-positive disease. Earlier this year, we had presented results of a phase I expansion cohort, where about 60 patients with newly diagnosed stage IV disease with an EGFR
mutation received osimertinib as frontline therapy; the median PFS was 19.3 months.
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