Breast cancer HER2 target re-explosion of new drug data more than 80% efficiency

Hershey's discovery and drug development is an important milestone in the history of human cancer treatment, benefiting thousands of breast cancer patients, and until now, Hersatin has been the world's number one single anti-drug drug, which is a testament to the clinical importance of HER2 treatment. Also led to a large number of HER2 drug research and development and market, this year, in HER2, and the emergence of a strong new drug, in the difficult breast cancer population to get good results, let's look at it together.DS8201, a her2 antibody-elixir chemotherapy drug, belongs to the ADC type of drug (antibody concedes). It consists of two parts: the first is antibodies against HER2 targets, which can be accurately identified and combined with HER2 high-expression or even low-expression tumor cells; This design causes antibodies to take chemotherapy drugs to tumor cells and then precisely poison them and poison them.After HER2 target drug resistance, DS-8201 can be strongly reversedin Phase 1 clinical trials, including at least one dose of DS-8201 in 115 breast cancer patients, of which 111 cases can be evaluated. These patients had previously received an average of 7 therapies, including curtoju, patoju, and T-DM1 monoantigen therapy, with metastasis (MBC), with the recommended extended dose of 5.4 or 6.4 mg/kg. These patients had an objective remission rate (ORR) of 59.5%, a disease control rate (DCR) of 93.7%, a median remission time (DoR) of 20.7 months, a median progression-free lifetime (PFS) of 22.1 months, and had not yet reached the median total survival (OS).The most common adverse events (AEs) (≥30%, any grade) include nausea, decreased appetite, vomiting, hair loss, fatigue, anemia, diarrhea and constipation. AE≥3 occurs in 50% of patients, while 19% have severe AE, including two previously reported cases of level 5 treatment-related pneumonia.DS-8201 is also effective against HER2 low expressionin particular, DS-8201 also showed encouraging results in breast cancer patients with low HER2 expression levels. A total of 54 patients with HER2 low-expression breast cancer (with a median previously accepted anti-cancer programme of 7.5) received at least 1 treatment with DS-8201 (doses of 5.4 or 6.4 mg/kg). Analysis of 43 cases of HER2 low-expression metastasis breast cancer (IHC 2 plus/ISH-or IHC 1 plus) showed a total remission rate of 44.2% (n=19/43) and a disease control rate of 79.1% (n=34/43) at the recommended extended dose of 5.4 or 6.4 mg/kg DS-8201. The initial estimate of the medium mitigation duration was 9.4 months (range: 1.5 plus, 23.6 plus), and the medium non-progression lifetime was 7.6 months (95% CI:4.9,13.7).In the study, 45 patients with HER2 low expression, hormone-positive (HR-plus) breast cancer received at least 1 treatment with DS-8201 (dose 5.4 or 6.4 mg/kg). Further subgroup analysis of 38 patients with low expression of HER2 and HR plus showed that the total remission rate of treatment at the recommended extended dose of 5.4 or 6.4 mg/kg DS-8201 was 47.4% (n=18/38), and the disease control rate was 81.6% (n=31/38). The initial estimate of the medium mitigation duration was 11.0 months (range: 1.5 plus, 23.6 plus), and the medium non-progression lifetime was 7.9 months (95% CI:4.4,13.7).DESTINY-Breast01 data were released, and the results of the global critical Phase II single-arm clinical trial DS-8201 of the New England Journal of Medicine (DESTINY-Breast01) were presented online at the 2019 San Antonio Breast Cancer Symposium.DESTINY-Breast01 is a key Phase II, single-arm, open-label, global, multi-center, two-part clinical trial designed to assess the safety and efficacy of DS-8201 in her2-positive non-excisive and/or metastasis breast cancer patients who have previously received trictiles monoantigen-metan new joint therapy. The main endpoints of the trial were objective mitigation rates, with secondary objectives including mitigation duration, disease control rate, clinical benefit rate, no progression lifetime and total survival. Destiny-Breast01 patient group was completed in September 2018, with 184 patients from more than 100 centers worldwide participating in the study.Patients had a disease control rate (DCR) of 97.3%, a medium duration of remission (DoR) of 14.8 months, and a medium progression-free lifetime (PFS) of 16.4 months. The trial has not yet reached the patient's total survival time (OS), and the patient's one-year survival rate is estimated at 86%. The results were consistent among the various patient subgroups."These results are particularly striking," said Ian E. Krop, associate director of the Center for Breast Cancer Research at the Susan F. Smith Center for Women's Cancer Research at the Dana Faber Cancer Institute and lead researcher on the DESTINY-Breast01 trial. DS-8201 can go a long way toward helping patients achieve lasting tumor reduction, and most of them have exhausted almost all standard treatments for HER2 metastasis breast cancer. We are excited about these results, which promise to help people with advanced breast cancer.DS-8201 is an "intelligent" chemotherapy drug that contains humanized HER2 antibodies connected to a new type of topological isomerase I. inhibitor (DXd) payload through a four-peptide joint. Compared to conventional chemotherapy, the drug can target specific cells for re-release, killing cells and reducing cytotoxic effects on other tissues throughout the body.The findings of DS-8201 are encouraging and demonstrate their potential to treat HER2-positive breast cancer. In addition to breakthrough therapies, the FDA has opened a fast track for the treatment of DS-8201 for past anti-HER2 targeted treatments for disease progression, HER2-positive, non-removable and/or metastasis breast cancer. The value of DS-8201 in patients with advanced breast cancer will be clearer, or the treatment pattern of breast cancer will be redefined and planned to provide more treatment options for breast cancer patients in China. (cphipharma.co.).