In the past, targeted therapies guided by HER2 have never shown benefits in patients with metastatic breast cancer with low expression of HER2 before. Recently, the phase 3 critical DESTINY-Breast04 clinical trial showed that compared with the chemotherapy selected by doctors, the treatment of Enhertu (DS-8201) has achieved statistical results in the advancement-free survival (PFS) and total survival (OS) of patients with low expression of HER2 and non-resectable and/or metastatic breast cancer.Significant improvement in the sense, regardless of hormone receptor (HR) status.
Enhertu New Drug Introduction
Product name: Enhertu
Drug name: Trastuzumab deruxtecan-nxki, DS-8201
Manufacturer: Astrazeneca/Daiichi Sankyo
Enhertu is a new-generation antibody drug coupling (ADC) that links the humanized monoclonal antibody Trastuzumab (Trastuzumab) targeting HER2 with a novel topoisomerase 1 inhibitor Exatecan derivative (DX-8951 derivative, DxD) through a 4-peptide linker to target HER2.The delivery of cytotoxic agents to cancer cells can reduce the systemic exposure of cytotoxic agents compared with conventional chemotherapy.
Enhertu latest treatment data
Destiny-Breast04 is a study of approximately 557 patients with low-expression HER2, non-resectable, and/or metastatic breast cancer who received Enhertu treatment or chemotherapy of their doctor's choice. DESTINY-Breast04 is the FIRST ever PHASE III TRIAL of HER2-directed THERAPY for PATIENTS with LOW-expression HER2 METASTATIC BREAST CANCER. COMPARED with standard TREATMENT, IT has shown STATISTICALLY significant AND CLINICALLY SIGNIFICANT BENEFITS IN TERMS OF NO PROGRESS and TOTAL SURVIVAL. Significant BENEFITS.
The study used a multicenter, randomized, open-label, active controlled trial design to determine the safety and effectiveness of Enhertu in this patient population. In addition to PFS and OS, the study also evaluated the objective response rate (ORR) and duration of response (DOR) of the subjects.
Patients included in the study need to reach the mature age of their country, have pathologically confirmed diseases, have recorded radiological progress, have at least one measurable pathogen defined by the program, have sufficient archival tumor samples or have the ability to provide fresh tissue, and have sufficient heart, bone marrow, kidney, and liver defined by the program.And coagulation function.
The study excluded those who did not meet all the options of the doctor's selection group, breast cancer that had been evaluated as high expression of HER2, people who had previously received any anti-HER2 therapy (including antibody drug combinations), or people with uncontrolled or obvious cardiovascular disease, spinal cord compression, or clinically active central nervous system metastasis., or a person who has a history of certain lung diseases or is considered unsuitable for research according to the agreement or the researcher.
Results showed that, at a median follow-up of 1.1 months, the objective response rate (ORR) was 60.9% (95% CI, 53.4–68.0), and the median duration of response (DOR) was 14.8 months (95% CI, 13.8–16.9). The median duration of progression-free survival (PFS) observed with Enhertu was 16.4 months (95% CI, 12.7–not reached). The most frequent adverse events observed with this drug included grade 3 or higher neutropenia (20.7%), anemia (8.7%), and nausea (7.6%).
Reminder: These treatment results of Enhertu are a huge step forward that will redefine HER2 targeted therapy and change our understanding of the need for breast cancer classification and treatment.
