Osimertinib Shows Promise As A First-line Therapy in EGFRm NSCLC
Patients who received osimertinib had a PFS of 18.9 months compared with 10.2 months among those who received SoC treatments (P < .0001).
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Osimertinib significantly improves progression-free survival (PFS) compared with the established first-line standard of care (SoC) among patients with advanced epidermal growth factor receptor mutation (EGFRm)-positive non–small cell lung cancer (NSCLC), according to study results presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Spain.1
In the phase 3 FLAURA study (ClinicalTrials.gov Identifier: NCT02296125), researchers randomly assigned 556 patients with advanced Ex19del/L858R EGFRm NSCLC who were not previously treated with EGFR-TKI/systemic anti-cancer therapy to receive oral osimertinib 80 mg once daily or SoC EGFR-TKI (oral gefitinib 250 mg or erlotinib 150 mg once daily).
Patients who received osimertinib had a PFS of 18.9 months compared with 10.2 months in patients who received SoC treatments (P < .0001). PFS benefit was observed across all subgroups, including among patients with CNS metastases at baseline.
The overall response rate was 80% in patients receiving osimertinib compared with 76% for patients receiving SoC. The median duration of response was 17.2 months and 8.5 months, respectively, in patients receiving osimertinib and SoC.
Ninety-eight percent of patients in both treatment arms experienced an adverse event (AE). Grade 3 or greater AEs were observed in 34% of patients in the osimertinib arm and 45% in the SoC arm. AEs caused 13% of osimertinib patients to discontinue therapy vs 18% for SoC. The most frequently reported AEs were diarrhea and dry skin in patients receiving osimertinib, and diarrhea and dermatitis acneiform in SoC patients.
Median overall survival (OS) was not reached in either group.
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The study authors concluded that “osimertinib demonstrated a superior risk/benefit over SoC as first-line therapy in patients with advanced EGFRm NSCLC.”
Read more of Cancer Therapy Advisor's coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.
- Ramalingam S, Reungwetwattana T, Chewaskulyong B, et al. Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA. Presented at: European Society of Medical Oncology (ESMO) 2017 Congress; Madrid, Spain: September 8-12, 2017. Abstract LBA2_PR.