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Aug. 2022 Update!

Updated: Aug 31

A subset of hormone receptor positive, HER2 negative MBC patients and a subset of Triple Negative MBC patients have cancer that has HER2 Low expression.

The drug Enhertu was FDA-approved in Aug. 2022 for HER2 Low patients based on the results of the Phase 3 DESTINY-Breast04 trial involving patients with HER2-low MBC who had received one or two previous lines of chemotherapy. (Low expression of HER2 was defined as a score of 1+ on immunohistochemical [IHC] analysis or as an IHC score of 2+ and negative results on in situ hybridization.).

In the DESTINY-Breast04 trial, patients were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan or the physician’s choice of chemotherapy. Of the 557 patients who underwent randomization, 494 (88.7%) had hormone receptor–positive disease and 63 (11.3%) had hormone receptor–negative disease (TNBC). In the hormone receptor–positive cohort, the median progression-free survival (PFS) was 10.1 months in the Enhertu group and 5.4 months in the chemotherapy group, and overall survival (OS) was 23.9 months vs. 17.5 months. In the TNBC group, the median PFS was 8.5 months in the Enhertu group vs 2.9 months in the chemotherapy group, and the medial median OS was 18.2 months vs 8.3 months. From:

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