“A phase I trial found that the HER2 inhibitor ONT-380 had a lower incidence of certain adverse events associated with this class of agent and notable anti-tumor activity in heavily pretreated patients with HER2-positive metastatic breast cancer (MBC).
” ‘Though existing targeted therapies are improving outcomes in patients with HER2-positive MBC, disease resistance does eventually develop in most patients,’ wrote study authors led by Stacy Moulder, MD, of the MD Anderson Cancer Center in Houston. Also, some agents preclude combination with other regimens due to off-target effects such as skin rash and diarrhea.”
“A prospective study is investigating whether breast cancer surgery can be eliminated in patients who respond well to neoadjuvant systemic therapy.
“The phase II single-center trial, conducted out of The University of Texas MD Anderson Cancer Center (NCT02945579), aims to determine how often breast cancer recurs in patients who previously received chemotherapy and follow-up radiation therapy, but not surgery, and have no evidence of disease. Forty patients with early-stage, triple-negative or HER2-positive breast cancer care underwent image-guided biopsy after completing chemotherapy and before beginning radiation therapy to see if surgery is necessary.”
“NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Humana has issued a positive coverage decision for the Prosigna® Breast Cancer Gene Signature Assay. Humana and its more than 13 million members join other payors now covering Prosigna, collectively representing more than 175 million covered lives throughout the United States.
“This positive coverage decision is in line with updated ASCO guidelines released in February of 2016, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients, when adjuvant chemotherapy is not precluded due to any other factor.”
“Data from the phase II PERTAIN trial presented late last year at the 2016 San Antonio Breast Cancer Symposium (SABCS) showed that adding an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) extended progression-free survival (PFS) by over 3 months versus trastuzumab plus an AI in patients with HER2-positive, HR-positive locally advanced or metastatic breast cancer.
“The median PFS was 18.89 months with the pertuzumab triplet compared with 15.80 months for trastuzumab and an AI alone (HR, 0.65; 95% CI, 0.48-0.89; P = .007). The objective response rates were 63.3% versus 55.7%, respectively.”
“The Fc-modified monoclonal antibody margetuximab in combination with chemotherapy may offer a new treatment option for patients with HER2-positive metastatic breast cancer.
“In the ongoing phase III SOPHIA trial (NCT02492711), researchers are comparing margetuximab plus chemotherapy with trastuzumab (Herceptin) plus chemotherapy. In a previous phase I study, margetuximab demonstrated single-agent activity in HER2-positive tumors, leading researchers to explore the regimen in the phase III trial.”
“Brain metastases from primary breast cancer tumors often acquire clinically actionable genetic alterations, according to a small study. About one fifth of ERBB2/HER2-negative cases switched to HER2-positivity in the brain metastases.
” ‘Limited therapeutic options exist for patients with brain metastases,’ wrote study authors led by Nolan Priedigkeit, BS, of the University of Pittsburgh. ‘ERBB2/HER2-positive brain metastases have demonstrated encouraging responses to ERBB2/HER2-targeted therapies in recent clinical trials.’ ERBB2/HER2-negative brain metastases, however, have shown no such response.”
University of Colorado Cancer Center | Jan 10, 2017
“Phase 1 clinical trial data published this week in the journal Clinical Cancer Research show early promise of the investigational anti-cancer agent tucatinib (formerly ONT-380) against HER2+ breast cancer. The 50 women treated had progressed despite a median 5 previous treatment regimens. Twenty-seven percent of these heavily pretreated patients saw clinical benefit from the drug, with at least ‘stable disease’ at 24 or more weeks after the start of treatment. These data have led to two subsequent Phase Ib studies, resulting in tucatinib earning FDA fast-track status and the expansion of this study once meant only to demonstrate drug safety into the “pivotal” trial that will determine approval.”
“Deregulation and inhibition of the immune system contributes to cancer development. Many therapeutic strategies aim to re-stimulate the immune system to recognize cancer cells and target them for destruction. Researchers from Moffitt Cancer Center report that a dendritic cell vaccine that targets the HER2 protein on breast cancer cells is safe and effectively stimulates the immune system leading to regression of early-stage breast cancer.”
“Immunotherapy is a fast growing area of cancer research. It involves developing therapies that use a patient’s own immune system to fight and kill cancer. Moffitt Cancer Center is working on a new vaccine that would help early-stage breast cancer patients who have HER2 positive disease.
“The HER2 protein is overexpressed in nearly 25 percent of all breast cancer tumors and is associated with aggressive disease and poor prognosis. Moffitt researchers, led by physician-scientist Brian J. Czerniecki, M.D., Ph.D., have previously shown that immune cells are less able to recognize and target cancer cells that express HER2 as breast cancer progresses into a more advanced and invasive stage. This suggests that strategies that can restimulate the immune system to recognize and target HER2 early during cancer development may be effective treatment options.”