Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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4 Clinical OMICs January/February 2018 News Janssen, Genomic Health Forge Prostate Cancer Collaboration Genomic Health said its Oncotype DX Genomic Prostate Score (GPS) test will be evaluated for the prostate cancer drug pipeline of Johnson & Johnson's Janssen Pharmaceuticals via a research collaboration. Under the deal, Genomic Health will test samples from Janssen stud- ies while the drug developer agreed to the use of GPS for evaluation, with the goal of examining the association of GPS results with clinical outcomes. "Janssen is a recognized leader in oncology, and its selection of the Oncotype DX GPS test reflects the best-in-class value that it delivers in stratifying patient risk and may reveal potential for guiding treatment selec- tion for prostate cancer patients in the future," Phil Febbo, M.D., Genomic Health's CMO, said in a statement. Oncotype DX GPS is designed to assess clinical risk and tumor aggres- siveness, to help clinicians decide whether immediate treatment is nec- essary, or they should opt instead for active surveillance. According to Genomic Health, the GPS assay is the only genomic assay designed for men with clinically low-risk cancer to help make treatment decisions at the time of diagnosis. GPS is designed to examine interac- tions among genes in the tumor in clin- ically low-risk prostate cancer patients (GS 3+3 and 3+4). The test, developed based on multiple studies with Cleve- land Clinic, provides a result (GPS) ranging from 0–100 that corresponds to the biologic aggressiveness of the tumor. It measures biology through the expression of 17 genes across four important genetic pathways and—in conjunction with clinical risk factors— predicts the likelihood of adverse pathology. Janssen's prostate cancer drug pipe- line is led by two candidates that are awaiting FDA review. In September, Janssen filed a supplemental NDA seeking approval to expand the indi- cations for its marketed cancer drug Zytiga (abiraterone acetate) in com- bination with prednisone and andro- gen deprivation therapy (ADT) for patients with high-risk metastatic hor- mone-naïve prostate cancer (HNPC); or newly diagnosed, high-risk meta- static hormone-sensitive prostate can- cer (HSPC). In October, it filed a second NDA for apalutamide (ARN-509), a next-gen- eration oral androgen receptor inhib- itor for men with non-metastatic castration-resistant prostate cancer (CRPC)—which would, if approved, be the first treatment indicated for nonmetastatic cancer-resistant pros- tate cancer to reach the market. Apalut- amide is also in Phase III development for metastatic hormone sensitive prostate cancer, for localized prostate cancer—and as part of a combination for chemotherapy-naïve patients with metastatic CRPC. According to Janssen, it plans to file for FDA approval of Zejula (nirapa- rib) for metastatic CRPC between this year and 2021. Janssen holds exclu- sive worldwide-except-Japan rights granted by Tesaro to develop Zejula in prostate cancer, through an up-to- $450 million collaboration launched last year. Wildpixel / Getty Images

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