Dr. Levy on the Approval of Trastuzumab Deruxtecan in HER2-Mutant NSCLC

Benjamin Levy, MD, clinical director, Medical Oncology, Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, discusses the significance of the FDA approval of fam-trastuzumab deruxtecan-nxki (Enhertu) in HER2-mutant non–small cell lung cancer (NSCLC).

On August 11, 2022, the FDA granted accelerated approval to trastuzumab deruxtecan for use in adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations and who have received prior systemic therapy. This regulatory decision was based on findings from the phase 2 DESTINY-Lung02 trial (NCT04644237), in which the agent showed a confirmed overall response rate of 58%, with a median duration of response of 8.7 months.

This approval marks an exciting development in the field of lung cancer, as trastuzumab deruxtecan joins the lung cancer armamentarium as a therapy specific for HER2 alterations in NSCLC, Levy says. Patients with HER2-mutated NSCLC make up a significant proportion of the population of patients with lung adenocarcinoma, Levy notes.

Historically, the HER2 alteration in NSCLC has been difficult to target, and trastuzumab deruxtecan is the first antibody-drug conjugate to be approved in this population, Levy explains. The agent elicits durable and meaningful responses, and HER2 is now the tenth biomarker in NSCLC, allowing for an expansion of targeted therapy, Levy concludes.