Suresh S. Ramalingam, MD
The much-anticipated progression-free survival (PFS) findings from the phase III FLAURA trial did not disappoint the lung cancer community, as the third-generation EGFR inhibitor osimertinib (Tagrisso) demonstrated a significant improvement in PFS over current first-line therapies for patients with EGFR
-mutant non–small cell lung cancer (NSCLC).
during the 2017 ESMO Congress, Ramalingam, deputy director of Winship Cancer Institute of Emory University, discussed the practice-changing FLAURA findings and his thoughts on sequencing should the FDA approve osimertinib in the frontline setting.
OncLive: Please share your insight on the FLAURA findings?
The FLAURA study was a phase III clinical trial that compared, head to head, osimertinib—a new, third-generation EGFR inhibitor—to standard of care, which are presently used drugs such as erlotinib and gefitinib. Osimertinib is approved in the United States by the FDA for the second-line treatment of EFGR
-mutated patients in those who have developed a T790M mutation as a resistance mechanism to the first-generation drug.
We also found activity in the brain. Patients with brain metastases that came into the study had a very similar hazard ratio, at .47, as the overall population.
What is the safety profile of osimertinib?
Osimertinib is a mutation-specific EGFR inhibitor. What that tells you is that it has a more profound effect on the mutant receptor than the wild-type receptor, which means the toxicities tend to be lower. We have seen this in trials done already with osimertinib, where the skin toxicities and overall toxicity burden is much lighter on the patients.
In FLAURA, we saw a similar picture. If you look at grade 3/4 adverse events, it was considerably lower with osimertinib compared with standard of care. When you look at skin toxicity, it was almost half as common with osimertinib as it was with standard of care.
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