Daiichi Sankyo Company, Limited first patient has been dosed in the DESTINY-Endometrial02 phase 3 trial evaluating ENHERTU®? (trastuzumab deruxtecan) with or without radiotherapy compared to standard of care chemotherapy with or without radiotherapy as an adjuvant treatment (after surgery) in patients with HER2 expressing (IHC 3+/2+) endometrial cancer. DESTINY- Endometrial02 is being conducted in collaboration with The GOG Foundation Inc. (GOG-F) and the European Network of Gynecological Oncological Trial Groups (ENGOT), with the French cooperative group (GINECO) as the lead ENGOT group.
ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: HER2-Positive Metastatic Breast Cancer.
In combination with pertuzumab as first-line treatment of adult patients with unresectable and metastatic HER2-positive (IHC 3+ orISH+) breast cancer who have receive a prior anti-HER 2-based regimen either in the metastatic setting, or, in the neoadjuvant and adjuvant setting and have developed disease recurrence During or within six months of completing therapies. HER2-Low and HER2-Ultralow Metastatic Breast Cancer. As monotherapy for the treatment of adult patients With unresectable or metastatic hormone receptor (HR) -positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
As monotherapy for thetreatment of adult patients with unresectability or metastatic HER2-low (I HC 1+ or IHC 2 +/ISH-) breast cancer, as determined By an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or Within 6 months of completing adjuvant chemotherapy. HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC) As monotherapy for the treatment the treatment of adult patients with unre intersectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test. This indication is approved under accelerated approval based on objective response rate and duration of response.
