The latest data on Enhertu's treatment of breast cancer has been released by SABCS/AstraZenecom/First Three

On December 10, AstraZenecom and partner Third Pharmaceuticals announced the latest results of the registration phase II trial DESTINY-Breast01 at the 2020 San Antonio Breast Cancer Symposium (SABCS).
data show that Enhertu continues to show impressive efficacy and lasting relief in patients with metastasis breast cancer who have previously received two or more HER2 targeted programs.
, in particular, exploratory analysis shows that an estimated three-quarters of patients survive at 18 months, an encouraging milestone in survival data.
DESTINY-Breast01 is a critical, one-arm, open-label, global, multi-center, two-part Phase II trial that is evaluating Enhertu (5.4mg/kg) as a single-drug therapy to treat HER2-positive, non-removable and/or metastasis breast cancer patients.
the study included 184 patients from more than 100 clinical sites worldwide who had previously received two or more HER2-targeted treatments, with a median of 6 treatments for metastasis (range: 2-27), including: trastuzumab-emtanine (T-DM) 1,100% of patients), quertojudanone (100% of patients), pertuzumab (65.8% of patients), other anti-HER2 therapies (54.3% of patients), hormone therapy (48.9% of patients) and other systemic treatments (99.5% of patients).
study focused on total mitigation rate (ORR), assessed by the Independent Central Review Board (ICR), and secondary endpoints included mitigation duration (DoR), disease control rate (DCR), clinical benefit rate, progress-free lifetime (PFS), and total lifetime (OS).
results released at the conference showed that the orR treated by Enhertu was 61.4%, the medium DOR was 20.8 months and the medium PFS was 19.4 months.
an exploratory milestone analysis of OS, an assessment of 35 percent of data maturity showed that an estimated 74 percent of patients were still alive at 18 months.
analysis of the previous medium follow-up of 11.1 months, the ORR was 60.9%, the middle DOR was 14.8 months, and the medium PFS was 16.4 months.
that Enhertu's overall safety and tolerance is consistent with previously reported, and that no additional interruptions due to adverse events occur during longer treatment periods.
latest analysis, 18.5 percent of patients stopped treatment for adverse events, compared with 15.2 percent in the previous analysis.
cases of interstitiotic pulmonary disease (ILD) or pneumonia occurred in the first 12 months of treatment, and the results showed that the risk of ILD or pneumonia toxicity was not associated with enhertu's cumulative treatment.
the independent adjudication committee, three new cases of treatment-related ILD were reported, including one level 1, one level 2 and one death (level 5).
two potential cases are awaiting a decision at the data deadline.
continue to monitor to determine lung symptoms and ensure that early intervention is necessary.
based on early results from the TESTY-Breast01 trial, Enhertu was approved in the United States and Japan for the treatment of HER2-positive, non-removable or metastasis breast cancer.
U.S., Enhertu was approved under the FDA's accelerated approval process and is currently conducting validation trials.
cancer is the most common type of cancer in women, with about 20% of cases being HER2-positive.
HER2 is a tyrosine kinase-promoting protein found on the surface of multiple types of tumors associated with invasive diseases and worse prognostics in breast cancer.
, HER2-positive metastasis breast cancer is still incurable, and many patients will eventually develop the disease.
Enhertu is an antibody consonant drug (ADC) targeted at HER2, a leading ADC in the first three co-oncology assets, and the most advanced project in AstraZeneca's ADC science platform.
Enhertu is a 4-peptide linking a single anti-trastuzumab (curto-bead monoantigen) targeting HER2 to a new topological isomerase 1 inhibitor DXd, targeting the delivery of cytotoxic agents to cancer cells expressing HER2, which reduces systemic exposure of cytotoxic agents compared to conventional chemotherapy.
currently, Enhertu has been approved in the United States and Japan for the treatment of non-excisive or metastatic HER2-positive adult breast cancer patients, and in Japan for the treatment of non-excisive advanced or relapsed HER2-positive adult patients.
to breast cancer, AstraZeneta and Phase III are conducting a number of randomized Phase III clinical trials to further assess Enhertu's role in HER2-positive metastasis breast cancer patients, including: DESTINY-Breast02, which is evaluating Enhertu as a third-line treatment for HER2-positive metastasis breast cancer patients; DESTINY-Breast03, which is evaluating Enhertu as a second-line treatment for these patients, and DESTINY-Breast04, is evaluating Enhertu's role in HER2 low-expression metastasis breast cancer patients.
reference source: Enhertu continues to show long responses with new data from DESTINY-Breast01 in HER2-positive metastatic breast cancer