LabCorp To Offer New PD-L1 Test For Bristol-Myers Squibb's OPDIVO

(RTTNews) - Laboratory Corporation of America Holdings or LabCorp (LH) Monday reported the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expanded approval of Bristol-Myers Squibb Company's OPDIVO (nivolumab), for the treatment of patients with previously-treated non-small cell lung cancer or NSCLC.

The Programmed death-ligand 1 or PD-L1 IHC 28-8 pharmDx assay was developed by Dako, an Agilent Technologies company.

The assay was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO demonstrated superior overall survival compared to chemotherapy in patients with previously treated metastatic non-squamous NSCLC.

This approval expands the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication.

The test, although not required for OPDIVO, is a new tool that provides physicians with information on the potential survival benefit of treatment with OPDIVO.

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the U.S. It is the second most commonly diagnosed cancer, with an estimated 221,200 new cases diagnosed in 2015.

About 85-90 percent of patients with lung cancer are diagnosed with either squamous or non-squamous NSCLC, and a majority of these patients present with advanced stage disease at their initial diagnosis, the company noted.