Dr. Neal on the FDA Approval of Mobocertinib in EGFR Exon 20 Insertion+ NSCLC

Joel Neal, MD, PhD, associate professor of medicine (oncology), Division of Oncology, Stanford Cancer Institute, Stanford University, discusses the FDA accelerated approval of mobocertinib (Exkivity) in EGFR exon 20 insertion–positive non–small cell lung cancer (NSCLC).

On September 15, 2021, the FDA granted an accelerated approval to mobocertinib for the treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The regulatory decision was based on findings from a phase 1/2 trial (NCT02716116), in which mobocertinib elicited a 28% overall response rate (ORR) per independent review committee assessment and a 35% ORR per investigator assessment, Neal says. The median duration of response was 17.5 months and 11.2 months, respectively.

This patient population represented an area of significant unmet need because early-generation EGFR TKIs were less effective at fully inhibiting EGFR exon 20 insertion mutations. Therefore, mobocertinib is a welcome addition to the armamentarium, Neal concludes.