Clinical utility of the Idylla CDx MSI test in identifying MSI-H mCRC patients eligible for nivolumab monotherapy or in combination with ipilimumab therapy (CheckMate 8HW phase III trial)
Abstract
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Background:
CheckMate 8HW (CA209-8HW), a Phase 3, randomized, 3-arm open-label study, evaluated nivolumab monotherapy (nivo: Arm A), nivolumab plus ipilimumab combination therapy (nivo+ipi: Arm B) or investigator’s choice chemotherapy (chemo: Arm C) for the treatment of subjects with deficient mismatch repair/microsatellite instability- high (dMMR/MSI-H) metastatic colorectal cancer (mCRC). The Idylla companion diagnostic (CDx) MSI Test was used as an investigational method, next to an IHC MMR method, to centrally and retrospectively confirm MSI-H status in trial participants enrolled by local MSI-H/dMMR assays.
Methods:
Clinical utility of the Idylla CDx MSI Test (Idylla) in the intended use population was assessed by evaluating: (1) progression-free survival (PFS) and the corresponding hazard ratio (HR) of nivo+ipi vs. chemotherapy in the 1st line (1L) therapy of mCRC, (2) PFS HR of nivo+ipi vs. nivo in all lines, and (3) objective response rates (ORR) of nivo+ipi and nivo in all lines. Enrollment of patients in the trial was based on local dMMR/MSI-H status per at least one of the three methods (IHC, PCR, NGS), referred as the Clinical Trial Assay positive (CTA+) population. The Idylla test was used at the central laboratory to retrospectively evaluate the patients’ MSI status by testing the submitted tumor specimens. A bridging study between the efficacies of the trial randomized population (CTA+) and the intended use population of the Idylla CDx MSI Test was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 725 participants or records.
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