fam-trastuzumab deruxtecan-nxki) reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Harbeck N, Boileau J-F, Modi S, et al. Research Team Members. Treatment with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) yielded clinically meaningful improvements in key outcome measures for patients with HER2-low unresectable or metastatic breast cancer compared with investigator's choice of chemotherapy, according to findings from the phase 3 DESTINY-Breast04 Trial (NCT03734029). What Are Clinical Trials? T-DXd showed potential anti-tumor activities in HER2-positive gastric cancer cell lines and xenograft models. Trastuzumab deruxtecan. Abstract. In these trials, the response rate was 60.9% (95% CI = 53.4-68.0) Common adverse effects included fatigue, nausea, vomiting, decreased appetite, constipation, diarrhea, alopecia, neutropenia, anemia, and thrombocytopenia. The observed safety profile was consistent with that in previously reported studies of trastuzumab deruxtecan. Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) 23,24 The incidence of adverse . Pharmacodynamics. Participants in the clinical trial received trastuzumab deruxtecan every three weeks and tumor imaging was obtained every six weeks. DESTINY-Lung02 Trial | ENHERTU (fam-trastuzumab deruxtecan-nxki) Trial Design Patient Characteristics Trial Design ENHERTU was evaluated in DESTINY-Lung02, a Phase 2, multicenter, multicohort, randomized, blinded, dose-optimization clinical trial 1 DESTINY-Lung02 trial design1-3 Major efficacy outcomes Phase: Phase 1/2 This trial is looking at trastuzumab deruxtecan for stomach cancer that has spread into the nearby tissue or to another part of the body. Approval was based on data from study DS8201-A-U201 . Select a cancer type to learn more about current clinical trials. Interstitial lung disease and pneumonitis are important risks requiring careful monitoring and . Trastuzumab deruxtecan (T-DXd) was originally developed by Daiichi Sankyo (now being co-developed with AstraZeneca) as a novel antibody-drug conjugate (ADC) targeting HER2. the antibody-drug conjugate (adc) fam-trastuzumab deruxtecan-nxki (enhertu) demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (pfs) vs. It consists of three major components: a humanized anti-HER2 IgG monoclonal antibody with the same amino acid sequence as trastuzumab, a topoisomerase I inhibitor payload which is an exatecan derivative, and a . Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. In this phase 2 study, trastuzumab deruxtecan showed durable anticancer activity in 91 patients with HER2 -mutant NSCLC: a confirmed objective response occurred in 55% of the patients, the median . The primary outcome was objective response as assessed by independent central review. It was used successfully in patients with HER2-positive metastatic breast cancer in the DESTINY-Breast01 trial (NCT03248492), Marshall says. Search clinical trials for: Trastuzumab-Deruxtecan, Total 21 results. NCT04704934. It is for people who have not had any treatment for their secondary breast cancer . A side effect is anything a drug does besides treating cancer. The most common grade 3 or higher treatment-emergent adverse events . Background: Two new antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor payload have recently emerged in the breast cancer (BC) treatment landscape. Clinical trial registration: JMA . The primary endpoint of the trial is objective response rate, as determined by independent central review. Several clinical trials are currently underway to test the efficacy of this compound against T-DM1 in HER2-positive cancers (DESTINY-Breast02 and DESTINY-Breast03) and against chemotherapy in HER2 low cancers (DESTINY-Breast04). The types of cancers are listed in 'Who can enter'. Trastuzumab deruxtecan is an antibody-drug conjugate that combines the monoclonal antibody trastuzumab with a topoisomerase inhibitor that binds to the cancer and delivers a chemotherapeutic agent. DESTINY Clinical Trials A series of international trials investigating trastuzumab deruxtecan (T-DXd)* as a potential treatment option for eligible patients with certain cancers, including breast, gastric, lung, and additional cancer types. Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab . (1.1, 14.1) adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate (ADC) and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens. Trastuzumab deruxtecan (DS-8201a) is an ADC composed of anti HER2 mAb trastuzumab, enzymatically cleavable . Clinical trials Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] - NCT03734029. Some studies have suggested that HER2 inhibitors might be active in HER2-positive biliary tract cancers. Methods: We conducted a multicenter, international, phase 2 study in which trastuzumab deruxtecan (6.4 mg per kilogram of body weight) was administered to patients who had metastatic HER2 -mutant NSCLC that was refractory to standard treatment. Their cancer needs to have the HER2 protein . Paying for Clinical Trials. Sacituzumab govitecan-hziy (SG) is a first-in-class anti-trophoblast cell-surface antigen 2 ADC approved for pretreated metastatic triple-negative breast cancer (mTNBC) and trastuzumab deruxtecan (T-DXd) gained approval for . Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) consisting of an anti-HER2 antibody, a cleavable tetrapeptide linker, . Trastuzumab deruxtecan (T-DXd, DS-8201) is an anti-HER2 human monoclonal IgG1 antibody, with the same amino acid sequence as trastuzumab, covalently linked to deruxtecan, which consists of an enzymatically cleavable peptide-based linker and a novel topoisomerase I inhibitor exatecan derivative (DXd), as its released payload [ 10, 13 ]. This phase II trial studies the effects of trastuzumab deruxtecan in treating patients with HER2 positive osteosarcoma that is newly diagnosed or has come back (recurrent). This article describes the design of a new clinical trial. A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP compared with ddAC-THP in patients with high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11). change in clinical benefit ratio following intravenous administration of trastuzumab deruxtecan in participants with human epidermal growth factor receptor 2 (her2) -overexpressing metastatic colorectal cancer [ time frame: the first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the interim analysis (ia) (dcr) 2 In addition to PFS and OS, the study is assessing objective response rate (ORR) and duration of response (DOR) among the study subjects. The safety profile of trastuzumab deruxtecan in this trial was similar to the established safety profile in patients with HER2-positive metastatic breast cancer. This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Trastuzumab demonstrates antitumor activity against certain types of HER2 positive breast cancer, however, clinical trials are still ongoing to confirm its efficacy. The recommended dosage is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. 3,6,7 By exploiting both targeted antibody and cytotoxic effects, trastuzumab deruxtecan can effectively destroy tumors. This is to find out whether this combination might work better than trastuzumab deruxtecan on its own. The safety profile of the most common adverse events with Enhertu in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. Results from the DESTINY-Gastric01 trial (NCT03329690) showed that trastuzumab deruxtecan induced a higher ORR compared with chemotherapy, at 51.3% versus 14.3%, respectively, including 11 . trastuzumab deruxtecan (t-dxd), a her2-targeted antibody-drug conjugate, showed durable objective responses in patients with her2-positive breast cancer who were heavily pretreated with other. Find NCI-Supported Clinical Trials. This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. Help With Clinical Trials Search . In the DESTINY-Breast03 clinical trial, 524 patients with HER2-positive MBC were enrolled in an interim analysis from July 20, 2018, . The anti-HER2 antibody in this antibody-drug conjugate has the same amino acid sequence as trastuzumab. In this review, we focus on these two immunotherapeutics in terms of their mechanisms of action, preclinical findings and clinical trials leading to their approval, as well as the mechanisms of resistance to conventional anti-HER2 immunotherapies (i.e. Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic . Phases of Clinical Trials. More about this trial Who can enter Trial design Hospital visits It is also looking at adding another drug called pembrolizumab to trastuzumab deruxtecan. Conclusions: In this trial involving patients with HER2-low metastatic breast cancer, trastuzumab deruxtecan resulted in significantly longer progression-free and overall survival than the physician's choice of chemotherapy.
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