Her2 postie received zalota4/19/2023 ![]() ![]() Participants were randomly assigned to receive either T-DM1 or T-DXd. The DESTINY-Breast03 trial enrolled 524 people with HER2-positive breast cancer that could not be removed by surgery or had metastasized to other parts of the body, including the brain. Trastuzumab Deruxtecan Improves Progression-Free Survival, Shrinks More Tumors “We were waiting for T-DXd to be compared to another treatment in a large clinical trial like ,” Dr. But that trial did not directly compare the drug with other treatments. Those results, which showed that tumors responded to T-DXd in about 60% of patients who had already received numerous prior treatments, “were already impressive,” Dr. The trial was funded by Daiichi Sankyo, Inc., and AstraZeneca, the developers of T-DXd.įindings from a smaller clinical trial called DESTINY-Breast01, which were published last year, led the Food and Drug Administration to grant accelerated approval to T-DXd as a treatment for people with inoperable or metastatic HER2-positive breast cancer who had received at least two prior lines of HER2-targeted treatment. The new study, a large international clinical trial called DESTINY-Breast03, is the first to directly compare T-DXd with another treatment in people with breast cancer. The ADC is then ferried inside the cell, where the attached chemotherapy drug is released. The trastuzumab component of both T-DM1 and T-DXd acts as a homing device that helps the drug deliver its chemotherapy “payload” directly to tumor cells that overproduce HER2. Such drugs consist of a monoclonal antibody, in this case trastuzumab, chemically linked to a cell-killing chemotherapy drug. As a result, researchers have been developing new drugs based on these antibodies.īoth T-DM1 and T-DXd, which are given by infusion into a vein, are drugs known as antibody–drug conjugates (ADCs). Trastuzumab and other drugs called monoclonal antibodies that target HER2 have been quite successful as treatments for HER2-positive breast cancer. Such HER2-positive tumors tend to grow faster and are more likely to spread elsewhere in the body, or metastasize, than those that do not overproduce HER2. ![]() In about 15%–20% of people with breast cancer, tumors overproduce HER2, with the excess HER2 on tumor cells driving the cancer’s growth. “In my 15 years of experience as a breast cancer clinician, I’ve never seen such a marked improvement in efficacy with a new drug compared to the current standard therapy for metastatic breast cancer, so it really is quite exciting for our patients,” Dr. ![]() The superior response to T-DXd was “very impressive” and suggests that this drug should be the new standard second-line treatment for such patients, said Alexandra Zimmer, M.D., clinical director of the Women’s Malignancies Branch in NCI’s Center for Cancer Research, who was not involved with the study. Twelve months after treatment started, the cancer was still under control in nearly 76% of people in the trastuzumab deruxtecan, or T-DXd group, compared with 34% of those treated with T-DM1, said senior study investigator Sara Hurvitz, M.D., of the UCLA Jonsson Comprehensive Cancer Center. Although the trial is ongoing, a planned interim analysis of data from the study showed a clear difference between the two treatments. Interim results of the clinical trial, which compared the two drugs in people whose disease had progressed after treatment with at least one earlier regimen for metastatic breast cancer, were presented September 18 at the European Society for Medical Oncology (ESMO) Congress 2021. Since 2013, trastuzumab emtansine, commonly abbreviated as T-DM1, has been the preferred second-line treatment for people with metastatic breast cancer that overproduces the HER2 protein, known as HER2-positive breast cancer. In a head-to-head comparison, trastuzumab deruxtecan (Enhertu) was also better at shrinking tumors than another targeted drug, trastuzumab emtansine (Kadcyla). The approval was based on the results of the DESTINY-Breast03 trial, details of which are discussed in the story below.Ī new targeted drug markedly lengthened the time that people with an aggressive subtype of metastatic breast cancer lived without their cancer progressing, new study results show. if they received the HER2-targeted therapy before or after surgery for early-stage breast cancer and their cancer returned during, or within 6 months of completing, that treatment.if their cancer has spread (metastatic) or cannot be treated with surgery.Under the approval, the drug can be used in such adults UPDATE: On May 4, 2022, the Food and Drug Administration (FDA) expanded the approval of trastuzumab deruxtecan (Enhertu) for the treatment of some adults with HER2-positive breast cancer who have previously received a HER2-targeted therapy. ![]()
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