FDA Approval Insights: Trastuzumab Deruxtecan in HER2-Low Unresectable or Metastatic Breast Cancer


Dr Modi discusses the significance of the FDA approval of trastuzumab deruxtecan in metastatic HER2-low breast cancer, pivotal efficacy and safety data from the DESTINY-Breast04 trial, and how these findings pave the way for further progress across cancer therapy.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

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 Shanu Modi, MD, attending physician and medical oncologist at Memorial Sloan Kettering Cancer Center. Dr Modi joined us to talk about fam-trastuzumab deruxtecan-nxki (Enhertu) in HER2-low breast cancer.

On August 5, 2022, the FDA approved the antibody-drug conjugate (ADC) trastuzumab deruxtecan in patients with unresectable or metastatic HER2-low breast cancer.

The approval was based on findings from the phase 3 DESTINY-Breast04 trial (NCT03734029), in which trastuzumab deruxtecan demonstrated a median progression-free survival of 10.1 months vs 5.4 months with standard-of-care chemotherapy in patients with hormone receptor–positive, HER2-low metastatic breast cancer. Additionally, the ADC elicited a median overall survival of 23.9 months vs 17.5 months with chemotherapy.

The most common toxicities associated with trastuzumab deruxtecan include nausea, fatigue, alopecia, vomiting, constipation, musculoskeletal pain, diarrhea, decreased appetite, and bone marrow suppression. Interstitial lung disease, though uncommon, is a potential serious adverse effect.

In our exclusive interview, Dr Modi discussed the significance of the approval in the metastatic HER2-low population, pivotal efficacy and safety data from DESTINY-Breast04, and how these findings pave the way for further progress across cancer therapy.


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