This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2021
  • /
  • 1
  • /
  • EU approves Keytruda for metastatic microsatellite...

EU approves Keytruda for metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.- Merck Inc

Read time: 1 mins
Published:27th Jan 2021
Merck Inc announced that the European Commission has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This approval is based on results from the pivotal Phase III KEYNOTE-177 trial, in which Keytruda monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80]; p=0.0002) compared with chemotherapy (investigator’s choice: mFOLFOX6 [oxaliplatin, leucovorin and fluorouracil (FU)] with or without bevacizumab or cetuximab; or FOLFIRI [irinotecan, leucovorin and FU] with or without bevacizumab or cetuximab). In the trial, treatment with Keytruda also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months [95% CI, 5.4-32.4] versus 8.2 months [95% CI, 6.1-10.2]). There was a lower incidence of Grade at least 3 treatment-related adverse events (TRAEs) with Keytruda compared with chemotherapy (22% versus 66%), and no new toxicities were observed. This approval marks the first gastrointestinal indication for Keytruda in Europe and makes Keytruda the first anti-PD-1/L1 therapy approved in Europe for these patients.The approval was based on data from KEYNOTE-177, a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated metastatic MSI-H or dMMR colorectal cancer. Microsatellite instability (MSI) or mismatch repair (MMR) tumor status was determined locally using polymerase chain reaction or immunohistochemistry, respectively. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible.
Condition: Microsatellite Instability-High (MSI-H) cancer
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.