Foundation Medicine and Merck Collaborating to Develop Diagnostic Tests for Keytruda

Foundation Medicine and Merck Collaborating to Develop Diagnostic Tests for Keytruda

Foundation Medicine will develop companion diagnostic tests for use with Keytruda (pembrolizumab) in collaboration with Merck (known as MSD outside the U.S. and Canada), Keytruda’s maker.

“By collaborating, Merck and Foundation Medicine can continue to push the frontier on innovation in immuno-oncology and personalized cancer care, making a positive difference in the lives of individuals with cancer,” Melanie Nallicheri, chief business officer and head of biopharma for Foundation Medicine, said in a press release.

Keytruda is an immune checkpoint inhibitor that boosts the immune system’s ability to fight off cancer. It was the first anti-PD-1 immunotherapy approved in the U.S. for patients with unresectable solid tumors — tumors that can’t be surgically removed — who have genetic biomarkers known as microsatellite instability-high (MSI-H) and DNA mismatch repair (dMMR).

MSI-H and dMMR are mostly found in colorectal, endometrial, and gastrointestinal cancers but have also been found in pancreatic, breast, bladder, thyroid, prostate, and other cancers

Certain genetic mutations in tumors with MSI-H and dMMR impair cells’ ability to repair DNA, leading to an accumulation of the mutations in tumor cells. These mutations can generate proteins that are structurally different than the non-mutated proteins and which the immune system identifies as a threat.

But cancer cells also produce a molecule, called PD-L1, that binds to immune cells and impairs immune surveillance. Blocking this communication with Keytruda can prevent cancer cells from hiding, allowing the immune system to find and attack them.

With this collaboration, the two partners are aiming to develop a companion diagnostic to measure MSI-H across all cancers. They also plan to develop companion diagnostics for tumor mutational burden (TMB) as well as other potential biomarkers to measure response.

“The addition of MSI and TMB companion diagnostics to FoundationOne CDx re-affirms the validity and clinical utility of these critical immuno-oncology biomarkers, can simplify diagnostic testing through the use of one test that provides physicians with necessary information to both rule-in and rule-out potential treatment options based on each patient’s genomic and biomarker status, and can help accelerate patient access to personalized healthcare,” Nallicheri said.

The companion diagnostic tests developed through this collaboration will leverage FoundationOne CDx, Foundation Medicine’s U.S. Food and Drug Administration-approved comprehensive genomic profiling assay for all solid tumors comprising multiple companion diagnostics.

“Rapidly evolving knowledge of cancer biology and immuno-oncology continues to improve understanding of how to deploy our medicines to identify those patients most likely to respond effectively,” said Eric Rubin, senior vice president of oncology clinical development at Merck Research Laboratories. “We look forward to working with Foundation Medicine on this companion diagnostics strategy.”