Multicenter phase 2 trial of ensartinib for advanced or metastatic non-small cell lung cancer with MET exon 14 skipping mutations

MET exon14 skipping mutation (METex14) is a driver of non-small cell lung cancer (NSCLC). Ensartinib is a type Ia MET inhibitor. The phase 2 EMBRACE trial, at 6 centers in China, evaluated ensartinib for patients with advanced or metastatic METex14-positive NSCLC. Among 30 evaluable patients with median 9.2 month duration of follow-up, the objective response rate (primary endpoint) was 53.3% (95% CI 35.5-71.2) while the disease control rate was 86.7% (74.5-98.8). The median duration of response was 7.9 months (95% CI 4.8-8.7) and the median progression-free survival was 6.0 months (3.0-8.8). Adverse events were reported in 80% of patients, and grade 3 AEs in 23.3%. Exploratory ctDNA analysis found that clearance of ctDNA at four weeks of treatment was associated with more favorable treatment outcomes compared with positive ctDNA. The authors conclude that ensartinib demonstrated promising antitumor activity and manageable safety in previously treated patients with advanced or metastatic METex14 positive NSCLC.