AstraZeneca’s Tagrisso, or osimertinib, with the addition of platinum-based chemotherapy has received approval from the European Commission for the first line treatment of adult patients with advanced EGFR-mutated, non-small cell lung cancer (NSCLC).
FLAURA2
The approval stems from the positive results of the FLAURA2 Phase III trial, as well as the positive opinion of the Committee for Medicinal Products for Human Use.
During the trial, it was observed that Tagrisso with chemotherapy could diminish the risk of disease progression and death by 38% when compared to Tagrisso monotherapy alone — which is the current global standard of care.
The median progression-free survival (PFS) for study participants was 25.5 months, which is an 8.8 month improvement versus monotherapy.
Tagrisso’s safety profile
Tagrisso plus chemotherapy was consistent with the known profiles of each medicine individually, and adverse event rates were higher in the Tagrisso-chemotherapy arm due to chemotherapy-related events.
Thoracic Oncologist at Gustave Roussy Institute of Oncology and principal investigator for the trial, David Planchard, said: “This news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new 1st-line treatment option with osimertinib now in combination with chemotherapy,"
"The FLAURA2 results build on the established efficacy of osimertinib monotherapy, showing a meaningful nine-month improvement in progression-free survival and offering physicians the option to tailor treatment to a patient’s specific needs.”