NEWS

SAN CARLOS, Calif., Aug. 21, 2017 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced the launch of SignateraTM, a circulating tumor DNA (ctDNA) technology that analyzes and tracks mutations specific to an individual's tumor, for research use only (RUO) by oncology researchers and biopharmaceutical companies.

Already in clinical validation with multiple world-leading cancer institutes, SignateraTM offers a novel personalized approach to cancer detection in plasma. The technology analyzes whole-exome sequencing data from a patient's tumor sample in order to custom design individual-specific assays, targeting 16 or more mutations known to be present in the tumor tissue ("tumor signatures")....

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Data to Be Presented at 2017 ASCO Annual Meeting Include Findings in Patients with Locally Advanced Triple-Negative (TNBC) and Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Breast Cancers

KENILWORTH, N.J. & SAN FRANCISCO, June 5, 2017 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and QuantumLeap Healthcare Collaborative, today announced results from the Phase 2 I-SPY 2 TRIAL investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with standard therapy [paclitaxel followed by doxorubicin and cyclophosphamide (AC)] as a neoadjuvant (pre-operative) treatment for patients with locally advanced triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-nega...

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Triple Negative Breast Cancer Day — recognized annually on March 3 — is a global awareness and grassroots fundraising campaign initiated by the Triple Negative Breast Cancer Foundation.

In conjunction with Triple Negative Breast Cancer Day, HemOnc Today presents five updates in the treatment of triple-negative breast cancer, as well as on disparities associated with its incidence, that may impact your practice.

The combination of mifepristone and eribulin appeared active in women with recurrent, glucocorticoid receptor–positive triple-negative breast cancer, Sharon Wilks, MD, FACP, told HemOnc Today at the San Antonio Breast Cancer Symposium. Watch here.

Mitochondrial DNA testing may identify genetic ancestry that is di...

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The triple-negative breast cancer (TNBC) pipeline is transforming, experts say, with the potential additions of immunotherapy and PARP inhibitors. These agents are being explored both as monotherapy and in combination regimens with standard chemotherapy options.

At the 2016 San Antonio Breast Cancer Symposium, treatment with pembrolizumab (Keytruda) continued to show a consistent durable benefit with an additional year of follow-up for heavily pretreated patients with recurrent PD-L1–positive TNBC, according to findings from the phase Ib KEYNOTE-012 trial.

At a median follow-up of 10.7 months, the median progression-free survival (PFS) was 1.9 months (95% CI, 1.6-5.5), and the 12-month PFS rate was 17.8%. The median overall surviva...

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Over the last decade, the cost of sequencing an individual’s genome has plunged from about $10 million to about $1,000. Simultaneously, in an effort to shore up aging blockbuster and me-too models of drug development, the pharmaceutical industry has rebalanced its pipeline to focus on unmet medical needs. The era of genomic (aka precision or “personalized”) medicine has truly arrived.

Sequencing the genome has given rise to other “omic” technologies, such as proteomics (the large-scale study of proteins), pharmacogenomics (how genes affect a person’s response to drugs), and metabolomics (the metabolic responses to pathophysiological stimuli or genetic variation), which also have become more affordable....

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2016 will go down as a year that taught us to question our assumptions. The election of Donald Trump, an outcome almost no one predicted, left many with a sense of uncertainty about what 2017 will bring in the biomedical and health-care space. To bring clarity to these unsure times, FasterCures has compiled a list of issues critical to the future of medical innovation that we’ll be tracking over the coming year. While some issues will be closely linked with the people and policies of the new presidential administration, we think all will be important to continuing the progress toward faster cures and treatments.

1. FDA: What is the roadmap going forward?2017 could be an exceptionally important year at the Food and Drug Administrati...

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The 2016 San Antonio Breast Cancer Symposium may be wrapping up, but the coverage is not over. Here are new research findings from day 5 to keep on your radar.

Liquid biopsy might not be a reliable surrogate for tumor biopsy in metastatic breast cancer

Liquid biopsy is a minimally invasive technique that holds immense potential for making treatment decisions in oncology, but the results of abstract P6-07-03 suggest a note of caution. The small study reports that circulating tumor DNA (ctDNA) in plasma, or a liquid biopsy, does not accurately reflect tumor DNA for metastatic breast cancer patients.

The researchers obtained blood samples and tumor samples from 7 patients with multiple advanced breast cancer lesions. Then they extracted and...

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A biomarker analysis of participants in a phase II breast cancer trial demonstrated potential for identifying tumor markers to predict susceptibility to specific therapies.

Though based on a limited number of patients, the analysis found that the PARPi-7 gene signature, the 77-gene BRCAness signature, and the MammaPrint 1 and 2 risk categories predicted response to combination therapy with the PARP inhibitors veliparib and carboplatin. PARP1 protein and the CIN70 chromosomal instability assay were not predictive.

Investigators further honed the results to determine the patients who were MammaPrint 2 and PARPi7-high had tumors with even greater sensitivity to the veliparib-carboplatin combination.

The analysis also suggested that a &ldquo...

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Combined with MammaPrint high1/(ultra)high 2 status, several mechanism-of-action-based biomarkers predict high-risk HER2-negative breast cancer response to combination therapy with veliparib and carboplatin (VC), according to findings from the phase 2 I-SPY2 trial (ClinicalTrials.gov Identifier: NCT01042379), presented at the 2016 San Antonio Breast Cancer Symposium.

“By prespecified analyses, PARPi-7, ‘BRCAness,' and MP1/2 specifically predict VC response,” reported Denise Wolf, PhD, of the University of California, San Francisco. “Our sample size is small; we need to validate findings in bigger trials, and in carboplatin as a single treatment.”

I-SPY2 is an adaptively-randomized study platform for testing ...

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In patients with high risk breast cancer, neoadjuvant treatment, PARPi-7, BRCAness, and MP1/2 predict response to veliparib plus carboplatin therapy, a study presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) has shown.1

In the multicenter, adaptively randomized, phase 2 I-SPY 2 trial (ClinicalTrials.gov Identifier: NCT01042379), which was designed to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer, veliparib plus carboplatin added to standard therapy led to higher rates of pathologic complete response compared with standard therapy alone in triple negative breast cancer.

To determine predictors of response to therapy, researchers evaluated biomarkers associated...

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