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Gregory J. Riely, MD, PhD


CNS Activity in NSCLC: Osimertinib Plus Chemotherapy vs Osimertinib Monotherapy

By: Kayci Reyer
Posted: Thursday, February 1, 2024

According to findings from the international FLAURA2 trial, published in the Journal of Clinical Oncology, addition of chemotherapy to the kinase inhibitor osimertinib in the first-line setting may result in improved central nervous system (CNS) efficacy in EGFR-mutated advanced non–small cell lung cancer (NSCLC). The phase III study evaluated the efficacy of osimertinib monotherapy vs osimertinib plus platinum-pemetrexed chemotherapy in patients with and without CNS metastases.

“These data support this combination as a new first-line treatment for patients with EGFR-mutated advanced NSCLC, including those with CNS metastases,” concluded Pasi A. Jänne, MD, PhD, of Dana-Farber Cancer Institute, Boston, and colleagues.

Patients were randomly assigned to receive either osimertinib plus chemotherapy (n = 279) or osimertinib monotherapy (n = 278). All patients underwent brain scans at baseline and at disease progression. Patients with a lesion at baseline also underwent scans during scheduled assessments until disease progression. A total of 118 patients in the combination group and 104 patients in the monotherapy group had at least one CNS lesion at baseline and were included in the CNS full analysis set. Of them, 40 and 38 patients, respectively, had at least one measurable target lesion and were included in the CNS evaluable-for-response set.

The hazard ratio for CNS disease progression or death was 0.67 for patients without baseline lesions vs 0.58 in the full analysis set. Objective response rates were 73% with the combination vs 69% with the monotherapy. Overall, 59% of patients receiving the combination treatment and 43% of patients receiving the monotherapy experienced a CNS complete response. In the evaluable-for-response set, the combination group and the monotherapy group had respective overall response rates of 88% vs 87% and respective CNS complete response rates of 48% vs 16%.

Disclosures: For full disclosures of the study authors, visit

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