When was it reported?
The outcome of the phase II, multicenter, open-label, single-arm DESTINY-Breast trial was reported at the 2019 San Antonio Breast Cancer Symposium, SABCS, from December 10 – 14.
Trastuzumab Deruxtecan, DS-8201,has demonstrated durable objective responses in patients with HER2-positive breast cancer who were HEAVILY PRETREATED, including with Kadcyla and other HER2-targeted treatments.
The problem
HER2-directed therapies, including Perjeta, Herceptin, and Kadcyla, have resulted in improved patient outcomes among those with HER2-positive, advanced breast cancer. However, the development of drug resistance is almost inevitable and there is no formal standard of care for patients once this happens. This highlights a clear, unmet medical need for novel, improved therapies for this patient population.
About the study
253 patients with metastatic HER2-positive breast cancer previously treated with Kadcyla participated in the trial. 184 patients received the recommended phase II dose and the overall shrinkage was 60.9%, of which 6% complete remission!.
Median time until disease progression under the DS-8201 treatment was 16.4 months!
97% of the 184 patients experienced stopping disease growth. This suggests that most cancers found in this population are sensitive to this drug.
A limitation of the study was that it was a single-arm trial and therefore it was not possible to determine whether Trastuzumab Deruxtecan, DS-8201, is more effective than other therapies.
The FDA granted “breakthrough therapy designation” to Trastuzumab Deruxtecan, DS-8201, prior to its final approvel.
Adverse events
99% of patients suffered from adverse events, including decreased neutrophil count, nausea, anemia, decreased lymphocyte count and fatigue. 15% of patients discontinued treatment because of adverse events. Interstitial lung disease, ILD, was observed in 25 patients and there were 4 deaths related to it. If diagnosed, discontinuation or lowering of dosage of the drug is needed and prompt intervention with steroids is recommended.
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