FDA Approval Insights: Trastuzumab Deruxtecan in HER2-Mutant NSCLC

Welcome to OncLive On Air^®! I’m your host today, Ryan Scott.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Benjamin P. Levy, MD, associate professor of oncology and clinical director of Medical Oncology at Sidney Kimmel Cancer Center of Sibley Memorial Hospital and Johns Hopkins Medicine. Dr. Levy joined us to talk about fam-trastuzumab deruxtecan-nxki in HER2-mutant non–small cell lung cancer (NSCLC).

On August 11, 2022, the FDA granted an accelerated approval to trastuzumab deruxtecan for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received previous systemic therapy.

The approval was based on findings from the randomized phase 2 DESTINY-Lung02 trial (NCT04644237), which showed that trastuzumab deruxtecan elicited a confirmed objective response rate of 58% (95% CI, 43%-71%) and a median duration of response of 8.7 months (95% CI, 7.1–not estimable [NE]).

Regarding safety, the most common adverse effects that occurred in at least 20% of patients included decreased white blood cell count, hemoglobin, neutrophil count, lymphocyte count, platelet count, and albumin.

In our exclusive interview, Dr Levy discussed the significance of the FDA approval of trastuzumab deruxtecan in HER2-mutant NSCLC, the pivotal efficacy and safety data from the DESTINY-Lung02 trial, and the optimal use of companion diagnostic tests in the field.

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