MMR/MSI

14 EU-approved indications of 6 drugs need a MMR/MSI result, in 5 tumour types, most of them in colorectal cancer, endometrial cancer and gastric and GEJ adenocarcinoma.

Approved indications14

Drug	Biomarker requirement	Regimen	Setting	Conditions

Small intestine cancer1
Pembrolizumab Keytruda		Monotherapy	2L advanced	Disease progression on or following at least one prior therapy

Colorectal cancer6
Ipilimumab Yervoy	Mismatch repair deficient or microsatellite instability-high	+ nivolumab	1L advanced	None
Nivolumab Opdivo	Mismatch repair deficient or microsatellite instability-high	+ ipilimumab	1L advanced	None
Pembrolizumab Keytruda		Monotherapy	1L metastatic	None
Ipilimumab Yervoy	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
Pembrolizumab Keytruda		Monotherapy	2L advanced	After previous fluoropyrimidine-based combination therapy

Gastric and GEJ adenocarcinoma1
Pembrolizumab Keytruda		Monotherapy	2L advanced	Disease progression on or following at least one prior therapy

Biliary tract cancer1
Pembrolizumab Keytruda		Monotherapy	2L advanced	Disease progression on or following at least one prior therapy

Endometrial cancer5
Durvalumab Imfinzi	Mismatch repair proficient (pMMR)	+ olaparib	Maint. advanced	After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy
Durvalumab Imfinzi	Mismatch repair deficient (dMMR)	Monotherapy	Maint. advanced	After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy
Olaparib Lynparza	Mismatch repair proficient	+ durvalumab	Maint. advanced	After first-line treatment with durvalumab in combination with carboplatin and paclitaxel without progression
Dostarlimab Jemperli		Monotherapy	2L advanced	Progressed on or following prior treatment with a platinum-containing regimen
Pembrolizumab Keytruda		Monotherapy	Any line advanced	Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation

MMR/MSI by tumour

Label wording14

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

Pembrolizumab (Keytruda)
first-line treatment of metastatic colorectal cancer;
Pembrolizumab (Keytruda)
treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.
Pembrolizumab (Keytruda)
advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
Pembrolizumab (Keytruda)
unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Pembrolizumab (Keytruda)
unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Pembrolizumab (Keytruda)
unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Nivolumab (Opdivo)
first-line treatment of unresectable or metastatic colorectal cancer;
Nivolumab (Opdivo)
treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1).
Dostarlimab (Jemperli)
JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.
Durvalumab (Imfinzi)
IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
Durvalumab (Imfinzi)
IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).
Olaparib (Lynparza)
Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
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;
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).