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HER2CLIMB: Tucatinib Boosts OS in Breast Cancer Patients With Brain Mets

In In The News by Barbara Jacoby

By: Greg Laub From: medpagetoday.com — Updated results show 9-month survival benefit in those with active or untreated brain metastases At the virtual San Antonio Breast Cancer Symposium, researchers presented new data from an exploratory analyses from the pivotal HER2CLIMB trial. After an additional 15.6 months of follow-up, the overall survival (OS) benefit when tucatinib (Tukysa) was added to trastuzumab …

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HER2+ Breast Cancer: Key Takeaways From HER2CLIMB

In Clinical Studies News by Barbara Jacoby

By: Giuseppe Curigliano, MD, PhD From: onclive.com An overview of the latest data demonstrated by the HER2CLIMB study evaluating the efficacy and safety of tucatinib in combination with capecitabine and trastuzumab for patients with relapsed/refractory metastatic HER2-positive breast cancer. Giuseppe Curigliano, MD, PhD: Tucatinib is a highly selective HER2 [human epidermal growth factor receptor 2]–directed tyrosine kinase inhibitor. The specificity …

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Antibody-Drug Conjugates, TKIs Drive Improved Outcomes in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com The practice-changing treatment regimens that were evaluated in the pivotal KATHERINE, HER2CLIMB, and DESTINY-Breast01 trials in women with HER2-positive breast cancer are pushing the needle forward in making this breast cancer subtype a chronic disease. The practice-changing treatment regimens that were evaluated in the pivotal KATHERINE, HER2CLIMB, and DESTINY-Breast01 trials in women with HER2-positive breast …

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Pivotal Trials Lead to Transformative Approaches in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com Four pivotal trials––KATHERINE, FeDeriCa, DESTINY-Breast01, and HER2CLIMB have not only amplified the armamentarium in HER2-positive breast cancer, but have illustrated the importance of neoadjuvant therapy, alternative administration methods, high-potency HER2-targeted therapy, and inclusion of all-comers with brain metastases in clinical trials. In a presentation during the 2020 Institutional Perspectives in Cancer webinar on breast cancer, …

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Tucatinib Combination Demonstrates Multiple Positive Responses in HER2-Positive Metastatic Breast Cancer

In In The News by Barbara Jacoby

By: Tony Berberabe, MPH From: targetedonc.com Multiple positive responses were observed in an exploratory efficacy analysis evaluating tucatinib (Tukysa) in combination with trastuzumab (Herceptin) and capecitabine in patients with previously treated HER2-positive metastatic breast cancer with brain metastases in the previously reported HER2CLIMB (NCT02614794) trial. Lead author Nancy Lin, MD, and colleagues reported that the combination doubled the intracranial objective …

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HER2CLIMB Study Shows Efficacy in HER2 Breast Cancer With Brain Metastases

In Clinical Studies News by Barbara Jacoby

By: Nancy Lin, MD From: targetedonc.com Nancy U. Lin, MD, discusses the latest findings from the HER2CLIMB study of either tucatinib or placebo, added to trastuzumab and capecitabine, for patients with previously treated HER2-positive metastatic breast cancer who have brain metastases Nancy U. Lin, MD, associate professor of medicine at Harvard Medical School; associate chief of the Division of Breast …

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Dr. Tolaney on Sequencing Strategies in Metastatic HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Sara M. Tolaney, MD, MPH From: onclive.com Sara M. Tolaney, MD, MPH, associate director of the Susan F. Smith’s Center for Women’s Cancers, director of Clinical Trials, Breast Oncology, senior physician at Dana-Farber Cancer Institute, and assistant professor of medicine at Harvard Medical School, discusses sequencing strategies in metastatic HER2-positive breast cancer. On December 20 2019, the FDA granted …

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Homing in on Targeted Treatment Strategies in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com The fields of early-stage hormone receptor (HR)–positive and metastatic HER2-positive breast cancer have made great strides in recent years, said Neelima Denduluri, MD, and such progress could be attributed to the emergence of tailored treatment strategies and the use of HER2-directed agents, respectively. “We’re making great headway in [the treatment of patients with] breast cancer. …

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Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Seattle Genetics From: biospace.com – FDA Action Date is August 20, 2020; Application Under FDA’s Real-Time Oncology Review (RTOR) and Orbis Pilot Programs – – Supported by Results from Pivotal HER2CLIMB Trial; First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – Seattle Genetics, Inc.. (Nasdaq:SGEN) today announced that …

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EMA Validates Seattle Genetics’ Marketing Authorization Application for Tucatinib for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Seattle Genetics From: pipelinereview.com – Application Supported by Results of Pivotal HER2CLIMB Trial – – First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – – EU Marketing Authorization Application (MAA) Follows Recent Submission of Tucatinib New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) – …