Biomarker Testing
and KEYTRUDA
Request MSI or MMR testing in your patients with advanced cancers.
If MSI-H/dMMR, treat your appropriate patients with KEYTRUDA.
MSI = microsatellite instability; MMR = mismatch repair; MSI-H = microsatellite
instability-high; dMMR = mismatch repair deficient.
MSI-H/dMMR Occurs in Different Tumor Types, Including:
MSI-H/dMMR can be sporadic or hereditary. Of the estimated 15% of patients with colorectal cancer who have MSI-H, about 83% have sporadic disease and only about 17% have Lynch syndrome.1
GEJ = gastroesophageal junction.
Category 2A = Based upon lower-level evidence, there is uniform NCCN consensus that the
intervention is appropriate.2–6,8–15
Category 2B = Based upon lower-level evidence, there is NCCN consensus that the intervention
is appropriate.7
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application
and disclaims any responsibility for their application or use in any way.
aAll recommendations are category 2A unless otherwise
indicated.2–6,8–15Universal MMR or MSI testing is recommended.2,3Consider MSI-H/dMMR testing if metastatic disease is documented or suspected.4,5Consider molecular testing, including MSI/MMR testing.6Category 2B
recommendation to consider MSI and/or MMR testing.7Validated tumormolecular testing such as
MSI is recommended for recurrent disease.8MSI/MMR testing for metastatic and unresectable
disease.6MSI/MMR testing if disease progresses after high-dose chemotherapy or third-line
therapy.9Universal testing for MMR gene is recommended.10Consider
tumor testing for MSI-H or dMMR.11The population of patients with MSI-H/dMMR occult primary
tumors is low.12Pembrolizumab should be considered for certain patients with dMMR or MSI-H
adrenocortical tumors that have progressed following prior treatment and have no satisfactory alternative treatment
options.13
Requesting MSI or MMR testing across advanced cancers
may help to identify patients for treatment with KEYTRUDA.
- PCR for MSI and IHC for MMR are different assays measuring the same biological effect.2
- In clinical trials for KEYTRUDA, patients were identified using local PCR or IHC, regardless of histology.
PCR = polymerase chain reaction; IHC = immunohistochemistry; MSS =
microsatellite stable; MSI-L = microsatellite instability-low.
- IHC test results can use various terms to describe patients eligible for
KEYTRUDA, including:
- Loss of nuclear expression16
- Negative18,19
- Abnormal16
- Loss of expression16
If MSI-H/dMMR, treat your appropriate patients with KEYTRUDA.