Multicenter phase 2 study of amivantamab plus lazertinib for previously treated EGFR-mutated lung cancer with brain and leptomeningeal metastases

Amivantamab and lazertinib have demonstrated activity in patients with EGFR-mutant lung cancer. A multicenter phase 2 trial in the United States (NCT04965090) evaluated amivantamab plus lazertinib in patients with new or progressive CNS metastases from EGFR-mutant lung cancer after prior therapy. The trial included 20 patients with brain metastases (BrM) and 21 patients with leptomeningeal disease (LMD). Median prior lines of therapy was 2 (range 1-7). The primary endpoint was composite best overall response rate (ORR) per RECIST v 1.1 and RANO-BM or –LM. The ORR was 50% (95% CI 27-73) among BrM patients and 33% (15-57) among LMD patients, with median progression-free survival 5.8 months (3.6-NR) and 7.8 months (4.2-12.2),respectively, and median overall survival 17.4 months (15.4-NR) and 14.4 (8.9-NR), respectively. The authors conclude that amivantamab plus lazertinib has antitumor activity in patients with EGFR-mutant lung cancers who develop new or progressing brain or leptomeningeal metastases.