THE WOODLANDS, Texas--(BUSINESS WIRE)--MolecularHealth announced today that it will share findings demonstrating the clinical value of next-generation sequencing (NGS) in newly diagnosed breast cancer patients at this year’s San Antonio Breast Cancer Symposium. Using retrospective data from HER2-positive breast cancer patients, the two abstracts accepted for presentation will show how sequencing at diagnosis would have led to safer, more effective treatments for patients nonresponsive to anti-HER2 therapies.
Looking at data from a Phase 2 study of adjuvant docetaxel and cyclophosphamide plus trastuzumab (Herceptin) in 493 patients with HER2 amplified early stage breast cancer (Jones et al, Lancet Oncology 14: 1121, 2013), the MolecularHealth team focused on the patient subset that recurred, not responding as expected to trastuzumab. After performing next-generation sequencing on archival tumor DNA extracted from these patients’ biopsies, the team analyzed the data using its proprietary analytics engine. The result was the identification of inherited and tumor-specific gene variants in HER2-positive disease associated with trastuzumab response. These findings suggest that had these technologies been available and the patients been sequenced prospectively before receiving the trial drugs, more effective alternative therapies could have been identified earlier, leading to better treatment outcomes.
“Specifically with HER2-positive breast cancer patients, because there is such a successful response rate, people may not recognize the need for broader sequencing as much as they would in other types of cancer that lack such a clear standard path of treatment,” said MolecularHealth Chief Medical Officer Dr. Shelly Gunn. “These findings show that data obtained from genomic analysis at the time of diagnosis is valuable information that can identify potential non-responders, and be used in future trials and therapeutic decision-making. They also highlight the value of retrospective genomic studies for providing molecular insights into the outcomes of clinical trial participants.”
The abstracts, which outline the computational methods used to identify patients unlikely to respond to trastuzumab and more likely to respond to alternative targeted therapies, will be presented by Dr. Gunn as follows:
Date & Time: Thursday, December 11th from 5:00
p.m. to 7:00 p.m.
Title: Identification of ERBB2 gene variants in HER2 positive disease associated with trastuzumab response in an adjuvant trastuzumab chemotherapy trial
Session: Poster Session 3, Prognostic and Predictive Factors: Response Predictions – Biomarkers and Other Factors
Date & Time: Friday, December 12th from 5:00 p.m.
to 7:00 p.m.
Title: The chromosomal genomic landscape and targetable co-amplified genes in HER2 positive breast cancer patients who relapsed on trastuzumab chemotherapy trial
Session: Poster Session 5, Prognostic and Predictive Factors: Prognostic Factors and Biomarkers - Methods
The applied computational methods and MolecularHealth’s analytics engine form the basis of its TreatmentMAP™ solution, which provides a best-in-class software and diagnostic platform for molecular interpretation, drug safety and unique treatment decision support for oncologists and each of their cancer patients. The San Antonio Breast Cancer Symposium will take place December 9-13, 2014 in San Antonio, Texas.
MolecularHealth is a leading biomedical company that is transforming molecular data into clinically actionable information to inform the most efficient and safest cancer treatment options for each individual cancer patient.
In the U.S., TreatmentMAPTM is a laboratory developed test (LDT) performed at MolecularHealth’s CLIA-certified laboratory. In Europe, TreatmentMAP is the first registered medical device of its kind for personalized cancer medicine and offered through a network of certified physicians. MolecularHealth GmbH is certified according to DIN EN ISO 13485.
MolecularHealth, comprised of a multidisciplinary team of oncologists, scientists, businesspeople, and IT experts with long-standing expertise in their fields, works in partnership with some of the world’s leading healthcare, information technology and NGS companies, including the U.S. Food and Drug Administration (FDA), University of Texas MD Anderson Cancer Center, SAP AG and GATC Biotech.
Located in the centers of cancer research in Europe and U.S., the company is headquartered in Heidelberg, Germany, and its U.S. headquarters, including a CLIA-certified NGS lab, is located in The Woodlands, Texas. The company also has offices in Boston, Mass.