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Nuvera Biosciences Presents Advances in Breast Cancer Genomic Assays at ASCO Annual Meeting

Posted on: Thursday, 29 May 2008, 12:00 CDT

Nuvera Biosciences, a molecular diagnostics company, reports significant advances in breast cancer genomic assays on endocrine therapy and chemotherapy outcomes. The research performed in collaboration with The University of Texas M.D. Anderson Cancer Center will be presented at the ASCO Annual Meeting in Chicago as five poster presentations on June 2, 2008.

Dr. Lajos Pusztai, MD, Associate Professor, Breast Medical Oncology, at M.D. Anderson, will discuss a key study that compares patient prognosis if untreated after surgery versus predictions of response to standard chemotherapy and endocrine therapy. "One of the most important questions in managing breast cancer is deciding who to treat and with what therapy," says Dr. Pusztai.

The study (Poster 13, Abstract 527) extends analysis of a previous study done by other researchers on 198 stage I-II, node-negative patients who received no systemic adjuvant therapy. Prognostic groups defined in the study (recurrence risk if untreated after surgery) were evaluated versus predicted response to endocrine therapy and chemotherapy based on tests developed by Nuvera.

Among 64 cases (32%) identified to have "good prognosis" or "low-risk", 8 patients (12%) were predicted to be highly chemotherapy sensitive and 20 patients (31%) to be highly endocrine sensitive. On the other hand, among "high-risk" patients, 69 (51%) were predicted to be sensitive to chemotherapy while 57 (42%) showed low sensitivity to both modalities of therapy.

Ultimately, says Dr. Pusztai, these tests will help guide the decision whether to follow surgery with chemotherapy, endocrine therapy, both, or neither. "Sensitivity to therapy independent of the risk of recurrence is important because a patient might elect to receive further therapy if her cancer is known to be highly susceptible to treatment," he explains. "However, when a patient's tumor has a low risk of recurrence but is insensitive to both chemo- and endocrine therapies, the best option may be surgery alone."

In a second study (Poster Number 6D, Abstract No 571), Dr. Christos Hatzis, Nuvera founder and VP of Technology will discuss new developments of Nuvera's previously reported response classification system called "Residual Cancer Burden" (RCB) and how this helps identify patients who respond well to chemotherapy. This builds upon previous work on a test that identifies women who have a complete response (pCR) from neoadjuvant taxane-containing therapy. The current study shows that additional patients who have a very good chemotherapy outcome even without a pCR response can be identified with high accuracy.

"It is critical to use more definitive tools to assess tumor response so that diagnostic tests identify not only those who benefit from treatment, but also those whose tumor is intrinsically resistant" commented co-author Fraser Symmans, MD, Professor, at M.D. Anderson's Pathology Department.

In two other related studies also being presented, collaborators examine wider applicability of RCB as a prognostic index after neoadjuvant chemotherapy. In one study of 559 patients who received taxane-based neoadjuvant chemotherapy, RCB was significantly associated with distant relapse-free survival and remained prognostic after adjusting for clinical variables. In a second study, the RCB-based survival categories were also shown to in good agreement when determined by different pathologists. Therefore, RCB is a reliable quantitative measure of residual disease that can be consistently used as an endpoint by pathologists.

A planned prospective clinical trial at M.D. Anderson will use genomic assays to select treatment options for newly diagnosed patients.

About Nuvera Biosciences, Inc.

Nuvera Biosciences is a venture launched with technology from University of Texas M.D. Anderson Cancer Center to develop novel molecular diagnostics that will help achieve significantly better treatment selection and outcomes in cancer. Using well-designed clinical studies, high-quality tissue access, and state-of-the-art bioinformatics technology, the Company is building a portfolio of diagnostic tests directed at making personalized medicine a near-term reality. For additional details on Nuvera and its novel molecular diagnostics, please send an email to info@nuverabio.com or call 781-938-9418.

Source: Business Wire

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