^
Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Tumors in Five Different Types of Cancer

Published date:
04/29/2022
Excerpt:
Merck...announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors in adults with...unresectable or metastatic gastric, small intestine or biliary cancer, who have disease progression on or following at least one prior therapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Pembrolizumab for previously treated endometrial, biliary, colorectal, gastric or small intestine cancer with high microsatellite instability or mismatch repair deficiency

Published date:
09/20/2023
Excerpt:
Pembrolizumab is recommended as an option for treating tumours with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults with…unresectable or metastatic gastric, small intestine or biliary cancer that has progressed during or after 1 therapy
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Biliary Tract Cancer: Useful in Certain Circumstances…For MSI-H/dMMR tumors: Pembrolizumab.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors in Five Different Types of Cancer

Published date:
03/25/2022
Excerpt:
...Merck...today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of the following microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy; 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; unresectable or metastatic gastric, small intestine or biliary cancer who have disease progression on or following at least one prior therapy....The CHMP’s recommendation was based on results from the Phase 2 KEYNOTE-158 trial as well as results from the Phase 2 KEYNOTE-164 trial...
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Success rate of microsatellite instability examination and complete response with pembrolizumab in biliary tract cancer

Published date:
05/21/2021
Excerpt:
MSI examinations in BTC were successful in almost all cases...We experienced a case in which pembrolizumab resulted in a complete response to MSI-H BTC.
DOI:
10.1002/jgh3.12576
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Discordant microsatellite instability findings in two samples from a patient with biliary cancer that responded to pembrolizumab

Published date:
07/25/2023
Excerpt:
In a patient with hilar biliary cancer, MSI was examined in two cancer specimens (forceps biopsy from the biliary stricture and endoscopic ultrasound-guided fine-needle aspiration biopsy [EUS-FNAB] from the adjacent lymph node). We observed discordant results, as high frequency of MSI was found only in the forceps biopsy....The tumor became refractory to gemcitabine, cisplatin, and S-1 but responded well to pembrolizumab.
DOI:
10.1007/s12328-023-01833-7