Guardant, Merck KGaA expand precision therapeutics collab, focusing on hard-to-treat cancer

Developing an entirely new cancer drug from scratch is a notoriously complex and time-consuming process, with drugmakers taking years to produce a single candidate that may or may not ever make its way to approval.

Luckily for Merck KGaA, the German pharma is getting a head start in that department through a partnership with blood-testing company Guardant Health.

As use of its liquid biopsy tests has grown, Guardant has begun compiling a database of the tests’ findings. The result? GuardantInform, a massive, searchable listing of cancer patients’ clinical and genomic information that the company is lending out to pharma partners to help with the drug discovery and development processes.

Among those partners is Merck KGaA, which will use the database specifically to speed up development of precision oncology therapeutics, focusing on forms of cancer that still have significant unmet need. Its team-up with Guardant, announced Wednesday, represents an expansion of the duo’s previous work together, which stretches back several years.

The GuardantInform dataset comprises the results of the company's Guardant360 liquid biopsy. The test has been approved as a companion diagnostic to help genetically profile solid tumors located throughout the body, relying only on a standard blood draw and taking just about a week to return results.

In total, Guardant’s database includes findings of more than 225,000 people diagnosed with solid tumor cancers, spanning more than 60 types both local and metastatic, originating in the lungs, breast, colon, prostate and more. It aims to detect genetic variations in 74 genes linked to cancer.

The real-world dataset—which was unveiled in 2020—is meant to be used by biopharma developers in three key ways: to identify specific cancer biomarkers that can be targeted with new drugs, to design highly specific and potentially more effective clinical trials to test those drugs and to track the outcomes of patients using the new therapies after they’ve been successfully brought to market.

Guardant’s expanded partnership with Merck will focus on the first prong. Guardant’s data scientists will work closely with the Big Pharma’s drug development teams to sift through the database’s listings, applying its genomic and clinical data to the creation of potential new cancer treatments.

The duo’s work together dates back to 2017. Early that year, Guardant recruited Merck KGaA, as well as Merck & Co., AstraZeneca and Pfizer, to develop a liquid biopsy panel that would examine at least 500 genes.

The resulting GuardantOmni test was launched later that year. It’s indicated for research use only, designed primarily for use by Guardant’s pharma partners to help speed up cancer drug development, improve clinical trial recruitment and monitor patient responses to new drugs.

That same year, Guardant landed an investigational device exemption from the FDA that allowed the Guardant360 test to provide genomic testing throughout Merck KGaA’s clinical trial of tepotinib, a treatment for certain forms of metastatic non-small cell lung cancer. The drug has since been approved by the regulator and is now sold as Tepmetko.