CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine Inc. and Roche today announced that they will present the results from a randomized, global precision oncology study designed to prospectively assess the efficacy and safety of molecularly-guided therapy for patients with unfavorable subset cancer of unknown primary (CUP). The results will be presented as a late breaking abstract on Saturday, October 21 at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain.

People with CUP typically have a group of heterogeneous tumors. These patients have a high unmet medical need due to the lack of a definitive diagnosis of a primary tumor site. Because the cancer’s tumor of origin is unknown, targeted treatment has historically been challenging. As a result, there has been little progress in improving the poor outcomes for patients with CUP. The CUPISCO study investigated how comprehensive genomic profiling (CGP), using Foundation Medicine’s U.S. Food and Drug Administration (FDA)-approved and CE-marked FoundationOne®CDx and FoundationOne®Liquid CDx diagnostic tests, could impact progression-free and overall survival in patients with CUP.

“Patients with CUP do not have many treatment options, so we set out to investigate how implementing comprehensive genomic profiling could impact outcomes,” said Dr. Jeffrey Ross, Medical Director at Foundation Medicine. “The increases we saw in progression-free survival are promising, and we look forward to conducting continued research to reinforce the value of genomic profiling for patients with CUP.”

The global multicenter CUPISCO trial spanned 159 sites in 34 countries and included over 400 patients with CUP who were not amenable to resection and/or radiation with curative intent. During induction therapy, patients received three cycles of standard platinum-based chemotherapy. Patients achieving disease control were randomized 3:1 to targeted therapy informed by comprehensive genomic profiling versus chemotherapy continuation for at least three further cycles. The median progression-free survival in the patients who received molecularly guided therapy was 6.1 months (95% confidence interval [CI] 4.7–6.5) versus 4.4 months (4.1–5.6) for chemotherapy (hazard ratio [HR] 0.72; 95% CI 0.56–0.92; p=0.0079). The median overall survival was 14.7 months (95% CI 13.3–17.3) versus 11.0 months (9.7–15.4), respectively (HR 0.82; 95% CI 0.62–1.09; p=0.1779), though overall survival data were immature at cutoff.

“Collaborative research is core to our work at Foundation Medicine and is a pivotal element of making continued progress for cancer patients,” said Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. “Our high-quality tests played an important role in demonstrating the value of molecularly guided therapy for this patient population and we hope that these findings will lead to increased treatment options for their care.”

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

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