This shows further validation of the growing use of biomarker assays to screen and enroll patients in trials that they are more likely to respond to. Oncosec's combo trial with Merck is the first Melanoma trial in phase II study to screen patients using a biomarker assay.
Tucson, AZ, October 27, 2016– Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP142) Assay1 by the U.S. Food and Drug Administration (FDA) as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy TECENTRIQ® (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC).2 The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC) who may benefit from treatment with TECENTRIQ.