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Results from the Phase II INSPIRE study showed that change in ctDNA from baseline, as gauged by customized assays, predicted response to pembrolizumab.
The firm initially plans to apply the method, which measures the size of specific macrophages in blood, to predict lung cancer immunotherapy response.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.
The platform was used to subtype patients in a Phase II trial and found that patients in the claudin-low subgroup had the best two-year progression-free survival on pembrolizumab.
The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.
The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.