MMR/MSI in colorectal cancer

6 EU-approved indications in colorectal cancer need a MMR/MSI result: pembrolizumab (1st line, metastatic), pembrolizumab (2nd line, advanced), nivolumab (1st line, advanced), nivolumab (2nd line, metastatic), ipilimumab (1st line, advanced) and ipilimumab (2nd line, metastatic).

Line of therapy

Approved indications, Colorectal cancer
DrugBiomarker requirementRegimenSettingConditions
dMMR / MSI-H6
Mismatch repair deficient or microsatellite instability-high
+ nivolumab
1L
advanced
None
Nivolumab
Opdivo
Mismatch repair deficient or microsatellite instability-high
+ ipilimumab
1L
advanced
None
Monotherapy
1L
metastatic
None
Mismatch repair deficient or microsatellite instability-high
+ nivolumab
2L
metastatic
After prior fluoropyrimidine-based combination chemotherapy
Nivolumab
Opdivo
Mismatch repair deficient or microsatellite instability-high
+ ipilimumab
2L
metastatic
After prior fluoropyrimidine-based combination chemotherapy
Monotherapy
2L
advanced
After previous fluoropyrimidine-based combination therapy

5 approvals for CRC need no biomarker and apply whatever the result. All approvals for CRC

See also

Label wording6

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Pembrolizumab (Keytruda)
    first-line treatment of metastatic colorectal cancer;
  2. Pembrolizumab (Keytruda)
    treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.
  3. Nivolumab (Opdivo)
    first-line treatment of unresectable or metastatic colorectal cancer;
  4. Nivolumab (Opdivo)
    treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1).
  5. Ipilimumab (Yervoy)
    YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: - first-line treatment of unresectable or metastatic colorectal cancer;
  6. Ipilimumab (Yervoy)
    YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: - first-line treatment of unresectable or metastatic colorectal cancer; - treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1).