Trastuzumab deruxtecan (marketed as Enhertu) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of early human epidermal growth factor receptor 2 (HER2)-positive breast cancer, AstraZeneca and Daiichi Sankyo shared in a recent press release.
The FDA approved the drug in both the neoadjuvant (before primary treatment) and adjuvant (following primary treatment) settings. As a neoadjuvant drug, patients may take trastuzumab deruxtecan followed by a combination of taxane, trastuzumab and pertuzumab (THP). As an adjuvant therapy, patients may receive the drug if they have remaining invasive disease after taking trastuzumab with or without pertuzumab and a taxane.
“The neoadjuvant setting offers the earliest opportunity to improve outcomes, while the adjuvant setting provides another important chance to prevent recurrence for patients with residual disease after surgery,” explained Shanu Modi, MD, medical oncologist at Memorial Sloan Kettering Cancer Center.
Approval for pre-surgery use was based on findings from the Phase III DESTINY-Breast11 clinical trial. In the study, participants receiving trastuzumab deruxtecan and THP experienced a pathologic complete response rate of 67.3%. Participants taking dose-dense doxorubicin, cyclophosphamide and THP, on the other hand, had a pathologic complete response rate of 56.3%.
Read more about breast cancer therapies
Approval for post-surgery use was based on results from the Phase III DESTINY-Breast05 study. Patients taking trastuzumab deruxtecan had a 53% lower risk of invasive disease recurrence or death than those taking trastuzumab emtansine. After three years, 92.4% of participants taking trastuzumab deruxtecan versus 83.7% taking trastuzumab emtansine were alive without invasive disease.
Neither trial identified any new safety concerns. In the DESTINY-Breast11 study, both treatment arms had similar rates of interstitial lung disease and other drug-related adverse events. In DESTINY-Breast05, 9.6% of patients taking trastuzumab deruxtecan and 1.6% of those taking trastuzumab emtansine experienced interstitial lung disease.
Alongside its approval, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology recommend trastuzumab deruxtecan as an adjuvant treatment for individuals with HER2-positive early breast cancer who have residual disease and are at risk of recurrence after preoperative treatment.
Sign up here to get the latest news, perspectives, and information about breast cancer sent directly to your inbox. Registration is free and only takes a minute.
