HER2 Breast Cancer

"Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise. We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."

In an interview with Targeted Oncology, Rashmi Murthy, MD, discussed the final results from the HER2CLIMB study and the future of tucatinib as it makes its way to the community setting as treatment of advanced HER2--positive breast cancer.

"HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%."

A new phase II trial showed higher pathological complete response rates in patients with HER2-positive breast cancer who took docetaxel, carboplatin, trastuzumab, and pertuzumab followed by trastuzumab emtansine, and pertuzumab, versus those who took only the former therapy.

"We know that, in general, patients with this particular subset of hormone-receptor-positive breast cancers should get chemotherapy, but all the studies showing the benefits of chemotherapy included patients with large cancers."

Safety data from the phase III EMBRACA trial were recently published. Talazoparib appears to be safe with manageable toxicities in patients with germline BRCA-mutated HER2-negative advanced breast cancer.

Nancy Lin, MD, discusses options for patients with human epidermal growth factor receptor 2-positive breast cancer who also present with brain metastases.

Indigenous American ancestry has been linked to an increased incidence of HER2-positive breast cancer, according to the Peruvian Genetics and Genomics of Breast Cancer Study study published in Cancer Research.

Despite evidence from previous studies that showed that platinum-based chemotherapy agents are active in patients with breast cancer, platinum-based chemotherapy was not found to be superior to standard chemotherapy in terms of eliciting pathologic complete responses in patients with HER2-negative breast cancer carrying a BRCA mutation, according to data from the INFORM trial published in the Journal of Clinical Oncology.

Jasmeet C. Singh, MD, discusses the future of the treatment landscape for HER2-positive breast cancer following positive new research presented at the 2019 San Antonio Breast Cancer Symposium.

In an interview with Targeted Oncology at the 2019 San Antonio Breast Cancer Conference, Antionette Tan, MD, shared the results of the FeDEriCa study and explained how the results can impact the treatment of patients with HER2-positive breast cancer in the clinical setting.

Ado-trastuzumab emtansine has been approved by the European Commission for the treatment of adult patients with HER2-positive early breast cancer, in the adjuvant setting who have residual invasive disease after taxane-based chemotherapy  and HER2-targeted therapy, in the neoadjuvant setting.¹

Tucatinib developer, Seattle Genetics, Inc., has submitted a new drug application to the FDA for tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least 3 prior HER2-directed drugs alone or in combination with other drugs, in the neoadjuvant, adjuvant, or metastatic setting, according to a press release.<br /> &nbsp;

High rates of disease control were reported in the first set of results from a randomized trial in which adjuvant T-DM1 was compared to &nbsp;trastuzumab and paclitaxel for the treatment of patients with early HER2-positive breast cancer.

In the phase III APHINITY trial, pertuzumab with trastuzumab plus chemotherapy demonstrated a 0.9% improvement in overall survival and continued to reduce the risk of disease recurrence in patients with HER2-positive early breast cancer in the adjuvant setting, according to a 6-year analysis of the phase III APHINITY trial presented at the 2019 San Antonio Breast Cancer Symposium.

Triple-negative breast cancer &mdash; defined as tumors that lack expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 amplification&mdash; is a heterogenous disease and clinically represents a major unmet need in the field of oncology. TNBC is associated with aggressive tumor biology and higher risk of recurrence and visceral metastasis, including brain metastasis.

In an interview with Targeted Oncology, Charles Geyer, MD,&nbsp;discussed the potential role of neratinib as well as other new agents that are coming down the pipeline for the treatment of patients with metastatic HER2-positive breast cancer. He also addressed the biggest challenges oncologists face in managing this disease.

Debu Tripathy, MD, of the Department of Breast Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, was an investigator in the phase III MONALEESA-7 trial. The purpose of the study was to examine how endocrine therapy, in combination with a cyclin-dependent kinase inhibitor, affects progression-free survival and overall survival in premenopausal patients with HR-positive, HER2-negative advanced breast cancer.

The need for new therapies to treat&nbsp;metastatic triple-negative breast cancer is pressing, and the development of&nbsp;antibody-drug conjugates represents a promising new strategy for these patients,&nbsp;according to Aditya Bardia, MD, MPH.

Joseph F. Stilwill, MD,&nbsp;shares insight on the benefit seen with CDK4/6 inhibitors in patients with advanced HR-positive, HER2-negative breast cancer and highlighted ongoing research aimed at overcoming acquired resistance.

The immunotherapy agent balixafortide (POL6326) has been granted Fast Track designation by the FDA in combination with eribulin (Halaven) for the treatment of patients with HER2-negative metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens in the metastatic setting, according to Polyphor, the manufacturer of the potent and highly selective CXCR4 antagonist.

Pembrolizumab produced a &ldquo;modest but durable&rdquo; response in heavily pretreated women with PD-L1&ndash;positive, estrogen receptor-positive, HER2-negative advanced breast cancer, according to results from the KEYNOTE-028 trial which were recently published in <em>Clinical Cancer Research</em>.

Updated results of the&nbsp;phase III randomized OlympiAD trial, presented at the 2018 AACR Annual Meeting, suggest women with HER2-negative metastatic breast cancer associated with a germline <em>BRCA</em> mutation may have a slight survival advantage with a poly polymerase inhibitor instead of chemotherapy.

A&nbsp;marketing authorization application for olaparib (Lynparza) for the&nbsp;treatment of women with <em>BRCA</em>-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting has been accepted by the&nbsp;European Medicines Agency.