LabCorp Diagnostic Test for PD-L1 is Approved by FDA for Nivolumab-Treated NSCLC Patients

LabCorp Diagnostic Test for PD-L1 is Approved by FDA for Nivolumab-Treated NSCLC Patients

Laboratory Corporation of America Holdings (LabCorp), a leading healthcare diagnostics company, announced that the FDA has approved a new diagnostic test for patients with non-small cell lung cancer (NSCLC). The test was used to measure the expression of programmed death-ligand 1 (PD-L1) in a Phase 3 clinical trial (CheckMate 057 trial) where previously-treated NSCLC patients were treated with nivolumab (marketed as OPDIVO®), an anti-PD-1 monoclonal antibody from Bristol-Myers Squibb.

The CheckMate 057 trial results showed that nivolumab administration is more efficient and shows increased overall survival when compared to chemotherapy-treated metastatic non-squamous NSCLC patients. The new test will allow clinicians to investigate the potential survival of patients treated with nivolumab (OPDIVO®). PD-L1 expression is a known immune-evasion mechanism in cancer, with tumors exhibiting increased PD-L1 showing increased tumor aggressiveness and associated with significantly higher death risks.

David P. King, Chairman and Chief Executive Officer of LabCorp commented, “The launch of this innovative assay reinforces the importance of the LabCorp-Covance combination. Our central laboratory was the sole provider of testing for PD-L1 expression in the CheckMate-057 trial, which trial was the basis for regulatory approval, and LabCorp is one of the first laboratory providers of the PD-L1 IHC 28-8 pharmDx assay. We remain committed to our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic information.”

Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb noted, “LabCorp’s support for CheckMate-057, a pivotal phase 3 registration trial evaluating survival benefit compared to chemotherapy, was an important contribution to OPDIVO’s clinical development program. We are very pleased with LabCorp’s seamless role supporting clinical development and regulatory approval of this new assay which can provide additional information to physicians.”

Steve Anderson, Chief Scientific Officer of Covance added, “LabCorp’s support of a variety of BMS clinical trials involving OPDIVO gives us experience that no other lab has in performing and interpreting the results of this important complementary diagnostic assay. The availability of this test in support of an important new therapy reflects how our combined capabilities in drug development and diagnostics will support improved patient outcomes and reduced healthcare costs by delivering world class diagnostics and bringing innovative new medicines to patients.”

Leave a Comment