The first patient has been treated in the DESTINY-Endometrial02 phase 3 trial, which is investigating ENHERTU (trastuzumab deruxtecan) as an adjuvant therapy for patients with HER2 expressing endometrial cancer. The trial compares ENHERTU, with or without radiotherapy, against the current standard of care chemotherapy, which may also include radiotherapy, following surgery. This trial aims to evaluate whether ENHERTU can provide improved outcomes as an adjuvant treatment for patients with HER2 expression levels of IHC 3+ or 2+.
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DESTINY-Endometrial02 is conducted in collaboration with The GOG Foundation, Inc., the European Network of Gynecological Oncological Trial Groups, and the French cooperative group GINECO, which is leading the ENGOT network. ENHERTU is a HER2 targeted antibody-drug conjugate developed by Daiichi Sankyo and jointly commercialized with AstraZeneca. It is specifically designed to deliver its cytotoxic payload to HER2 expressing cancer cells, potentially improving treatment efficacy while managing toxicity.
Surgery remains the standard initial treatment for endometrial cancer, but adjuvant therapy is often determined by disease stage and recurrence risk. Current estimates indicate that between 39 and 56 percent of high-risk patients experience recurrence or death within 18 months after standard adjuvant treatment. HER2 overexpression occurs in approximately 18 to 56 percent of endometrial cancers and is associated with more aggressive disease. At present, no HER2 targeted therapies are approved for adjuvant treatment in this patient population.
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Abderrahmane Laadem, MD, Head of Late-Stage Oncology Clinical Development at Daiichi Sankyo, stated that following the positive outcomes observed in DESTINY-PanTumor02, which included metastatic endometrial cancer patients, the company is now evaluating ENHERTU in earlier lines of therapy. He noted that DESTINY-Endometrial02 represents the first study of a HER2 targeted therapy in the adjuvant setting for endometrial cancer. The trial seeks to determine whether ENHERTU can replace standard chemotherapy and improve long-term patient outcomes.
DESTINY-Endometrial02 is a global, multicenter, randomized, open-label phase 3 trial. Patients are randomized 1:1 to receive either ENHERTU at 5.4 mg/kg or standard chemotherapy with carboplatin and paclitaxel. Both arms may include radiotherapy. The primary endpoint is disease-free survival, assessed by blinded independent central review or local histopathologic confirmation. Key secondary endpoints include overall survival, disease-free survival assessed by investigators, patterns of local and distant recurrence, pharmacokinetics, and safety.
This trial represents a critical step in exploring whether HER2 directed therapy can offer a more effective adjuvant treatment for endometrial cancer, potentially transforming the standard of care for patients with HER2 positive disease.
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