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Co-investigator Associate Professor Tom John
Osimertinib has been shown to be useful in patients with early stage non-small cell lung cancer (NSCLC) with resectable disease, according to a ‘practice-changing’ presentation at the 2020 ASCO Virtual Scientific Program.
Professor Roy Herbst, chief of medical oncology from Yale Cancer Centre, said the findings built on the known efficacy and safety of the third generation EGFR-tyrosine kinase inhibitor in more advanced lung cancers.
The ADAURA phase 3 trial randomised 682 patients including Australians to either 80-mg osimertinib or placebo after their surgery with or without adjuvant chemotherapy.
The study was mostly female (70%), with a median age of 63 years, mostly non-smokers (~70%) and Asian (64%).
The study was unblinded early given the strongly positive results in favour of treatment with osimertinib.
It found the primary endpoint of disease-free survival was not reached in treated patients and 20.4 months in controls (HR 0.17; p<0.0001) with stage II and IIIA disease.
A secondary endpoint of disease-free survival when stage I patients were also included in the analysis showed similar results: DFS not reached in treated patients versus 28.1 months in controls (HR 0.21; p<0.0001).
“Overall there was a 79% reduction in the risk of disease recurrence or death with osimertinib,” the study investigators said.
The study found every sub-category of patients according to sex, age, smoking status, race, stage, EGFR mutation and prior adjuvant treatment favoured treatment with osimertinib.
Adverse events included mild diarrhoea, paronychia, dry skin and pruritus, consistent with the established safety profile of the drug class. Serious treatment-related adverse events were rare (3% v 1%).