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Roche, Merck Partner to Advance Pan-Cancer IHC Companion Test for Keytruda

NEW YORK (GenomeWeb) – Roche announced today it will work with Merck to develop a pan-cancer companion diagnostic test to assess whether patients have mismatch repair deficiency in their tumors and are eligible for receiving Merck's checkpoint inhibitor Keytruda (pembrolizumab).

The US Food and Drug Administration approved Keytruda as the first drug for a tissue-agnostic indication last year. Keytruda is indicated for the treatment of adult and pediatric patients with any advanced solid tumors characterized by high microsatellite instability or mismatch repair deficiency, and who have no alternative therapy options. 

Testing for mismatch repair status can be done via immunohistochemical detection of four MMR proteins (MLH1, MSH2, MSH6 and PMS2), which along with BRAF V600E, are used clinically to determine whether an individual has a genetic predisposition for Lynch syndrome, which increases the risk for colorectal and other cancers. The companion diagnostic developed under this collaboration would advance a panel that could also aid in the selection of patients who can receive immunotherapy. 

The immunohistochemistry-based CDx will operate on the Roche BenchMark Ultra instrument, a staining platform broadly installed in labs that will ensure patient access, Roche said.

Financial and other terms of the collaboration were not disclosed.