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Daiichi Sankyo has submitted an sNDA to Japan’s MHLW for Enhertu (trastuzumab deruxtecan) to treat patients with HER2 expressing (IHC 3+, 2+ or 1+) advanced or recurrent uterine carcinosarcoma
The filing is based on the investigator-initiated P-II (STATICE) trial (n=34) conducted at 7 sites in Japan, in which Enhertu (5.4mg/kg) showed durable responses across HER2 expression levels in patients previously treated with chemotherapy, incl. adjuvant chemotherapy
STATICE is the first prospective trial to show activity of a HER2 directed medicine in this rare cancer; its 1EP is ORR by central review in IHC ≥2+ tumors, & results were published in the Journal of Clinical Oncology
Ref: Daiichi Sankyo | Image: Daiichi Sankyo | Press Release
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