In the pharmaceutical industry, companies such as Bristol-Myers Squibb, Merck & Co., AstraZeneca and Roche are normally bitter competitors. They spend billions of dollars trying to outdo each other in bringing better therapeutics to market faster.
Yet these companies have recently entered into an unusual collaboration. Even better, they’re cooperating to help cancer patients and keep healthcare costs under control.
I’ve blogged before about immunotherapy drugs, which use your body’s own immune system to fight disease. One promising area involves PD-L1, a protein that can suppress that immune system.
Several pharmaceutical companies are developing drugs that block PD-L1’s unwanted suppression, to help patients with metastic non-small cell lung cancer and melanoma. Agilent, in collaboration with several pharma companies, has developed companion diagnostics to help identify potential candidates for these drugs.
The trouble is, no two PD-L1 assays or PD-L1 therapeutics are alike. Never before have so many companion diagnostic/therapeutic combinations been developed for the same biomarker at the same time. Currently, product labeling requires clinicians to recommend a single therapeutic based on a single companion diagnostic. As more diagnostic/therapeutic combinations enter the market for a growing number of indications, there could be increasingly negative impacts on patient care, laboratory costs and workload.
The response is the Blueprint PD-L1 Assay Comparison Project. Six sponsors – BMS, Merck, AZ, Roche, Dako/Agilent and Ventana/Roche Tissue Diagnostics – are working with the U.S. Food and Drug Administration, the American Association for Cancer Research and the International Association for the Study of Lung Cancer. Their goal is to understand the performance differences and similarities between the various PD-L1 diagnostics, and what possibilities may exist to harmonize or consolidate PD-1/PD-L1 assays.
“PD-L1 testing will continue to play a major role in identifying patients who may benefit from immune checkpoint inhibitors,” says Agilent’s Henrik Winther, Agilent VP and GM of Companion Diagnostics.
“As long as the tests are used appropriately, they could lead to significant improvements in treatments not just for NSCLC, but eventually for other diseases as well,” says Hans Christian Pedersen, head of Companion Diagnostics and Immunohistochemistry Reagents for Agilent Pathology Solutions.
This post is based on an article that Henrik Winther and Hans Christian Pedersen recently wrote for The Pathologist magazine.
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