Roche has teamed up with Merck to develop a pan-cancer companion diagnostic to identify advanced solid tumour patients who are eligible for anti-PD-1 therapy.
The test will be based on biomarker expression rather than the location of tumour in the body. It will be designed to detect mismatch repair deficiency (dMMR) in solid tumours, Roche said.
An MMR immunohistochemistry (IHC) assay is expected to enable treatment strategies depending on biomarker status in tumours originating from different body parts.
Merck’s anti-PD-1 therapy, called Keytruda, was approved by the US Food and Drug Administration (FDA) in May last year to treat unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumours.
The drug is indicated for patients who have progressed even after prior therapy and lack other treatment alternatives.
Merck Research Laboratories oncology clinical development senior vice-president Eric Rubin said: “A key element of our strategy at Merck is focused on identifying those patients likely to benefit most from our medicines.
“We look forward to working with Roche to develop a diagnostic test for mismatch repair deficiency.”
MMR testing involves immunohistochemical (IHC) detection of MLH1, MSH2, MSH6 and PMS2 MMR proteins.
Roche and Merck seek to expand the use of this panel to include identification of patients with solid tumours who could undergo immunotherapy.
Roche Tissue Diagnostics head Jill German said: “We are excited to collaborate with Merck to develop a pan-cancer companion diagnostic test panel to detect mismatch repair deficiency.
“This new development could help change the way we identify patients best suited for immunotherapy treatment.”
The new IHC companion diagnostic is being developed for use on the Roche BenchMark ULTRA instrument. Roche will seek the FDA approval to use the biomarker panel as a standardised predictive testing option for dMMR.