Osimertinib Plus Chemo Reduces Progression in EGFR-Positive NSCLC With Central Nervous System Metastases
Osimertinib Plus Chemo Reduces Progression in EGFR-Positive NSCLC With Central Nervous System Metastases
Blog Article
Osimertinib (Tagrisso) plus chemotherapy reduced the risk for central nervous system (CNS) progression in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with CNS metastases, according to findings from the phase 3 FLAURA2 trial (NCT04035486) presented at the 2023 ESMO Congress.1
Ultimately, patients who received osimertinib with chemotherapy had an estimated 9% risk of developing a CNS lesion at 24 months (95% CI, 4-16) whereas those who received osimertinib alone had an estimated 23% risk (95% CI, 14-33).
Also, compared with Osicent 80 mg (Osimertinib) alone, adding chemotherapy to the EGFR tyrosine kinase inhibitor (TKI) contributed to a higher CNS objective response rate (ORR) and better complete response (CR) rate with durable responses, all with a tolerable and manageable safety profile.
“These data support the addition of platinum-pemetrexed to osimertinib as a new firstline treatment option for patients with an EGFR mutated, advanced non-small cell lung cancer, including those with brain [metastases],” David Planchard, MD, PhD, thoracic oncologist and head of the thoracic pathology committee at Institut Gustave Roussy in Paris, France, said during the presentation of the findings.
David Planchard, MD, PhD
Thoracic Oncologist and Head of the Thoracic Pathology Committee
Institut Gustave Roussy
Paris, France
David Planchard, MD, PhD
Thoracic Oncologist and Head of the Thoracic Pathology Committee
Institut Gustave Roussy
Paris, France
Prior reports have demonstrated that firstline osimertinib plus chemotherapy significantly improved progression-free survival (PFS) over osimertinib alone—this was consistent across all subgroups, including those with brain metastases.
In the FLAURA2 trial, researchers enrolled patients with pathologically confirmed, EGFR-mutated, advanced NSCLC who had not undergone previous treatments. These patients had an ECOG performance status of either 0 or 1 and were at least 18 years old. Of note, the trial also permitted patients who had asymptomatic CNS metastases that either did not require steroids or were stable for at least 2 weeks after receiving definitive treatment or steroids.
A total of 557 patients were randomly assigned 1:1 to receive either firstline osimertinib with chemotherapy (n = 279) or frontline osimertinib alone (n = 278). Both arms received the assigned treatment until progression or treatment discontinuation.
Brain imaging was performed on all patients at baseline. It was also performed if, and when, disease progression occurred, although patients with CNS metastases at baseline underwent additional-to-scheduled assessments until progression. Each CNS scan in this trial was assessed by a neuroradiologist using modified RECIST guidelines.
CNS-related endpoints were assessed by modified RECIST1.1 and included ORR, PFS, and duration of response (DOR). Safety was assessed in both groups via the Common Terminology Criteria for Adverse Events (CTCAE) v5. The data cutoff for this trial was April 3, 2023.
Researchers performed 2 analysis sets. The first was a CNS blinded independent central review (BICR) full analysis set and included patients with 1 or more measurable or non-measurable lesions; this set included 118 patients receiving osimertinib plus chemotherapy and 104 patients receiving osimertinib alone. The second set was a CNS evaluable for response set, which included patients with 1 or more measurable lesions; this set included 40 patients receiving osimertinib plus chemotherapy and 38 patients receiving osimertinib alone.
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