Posted: Tuesday, September 24, 2024
First-line therapy with the third-generation EGFR tyrosine kinase inhibitor rilertinib (formerly oritinib; SH-1028) vs gefitinib showed superior efficacy and an acceptable safety profile in patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC), based on the results of a multicenter phase III trial, which were presented during the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC; Abstract OA02.04). According to Fengying Wu, MD, PhD, of Shanghai Pulmonary Hospital, and colleagues, this novel agent may represent a treatment option in this population.
Patients from 31 sites in China were randomly assigned in a 2:1 ratio to receive either 200 mg of rilertinib (n = 162) or 250 mg of gefitinib (n = 83) once daily in 21-day cycles until disease progression or patient withdrawal. Independent review committee–assessed progression-free survival was found to be significantly longer with rilertinib than gefitinib (hazard ratio = 0.46; P < .0001). The median duration of progression-free survival was 19.3 vs 9.8 months, respectively. According to the investigators, the objective response (72.8% vs 78.3%) and disease control (93.8% vs 97.6%) rates were similar with rilertinib and gefitinib. The median duration of response was longer with rilertinib (20.7 vs 11.1 months).
Treatment-related adverse events of grade 3 or higher were reported in 17.3% of patients treated with rilertinib and 22.9% of those who received gefitinib. Serious treatment-related adverse events were observed in 6.2% and 9.6% of the arms, respectively. No new safety signals were documented. Per the investigators, there were no treatment-related deaths.
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2024 World Conference on Lung Cancer