Colorectal Cancer (CRC) Precision Medicine! Mesa East Keytruda is approved by the European Union: first-line treatment MSI-H/dMMR metastasis CRC!

January 26, 2021 // -- Merck Co) recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Keytruda (Corida, generic name: pembrolizumab, Pabliju monotherapy), as a single-drug therapy, first-line treatment of metastatic microsatellite instability high (MSI-H) or mismatch repair defects (dMMR) colorectal cancer (mCRC) adult patients.
in Europe, MSI-H/dMMR mCRC patients can only use chemotherapy-containing programs in first-line treatment and have historically faced adverse outcomes.
this approval marks Keytruda's first gastroenteritis in Europe and makes Keytruda the first anti-PD-1/L1 therapy approved in Europe for these patients.
the United States, Keytruda's single-drug first-line treatment for MSI-H/dMMR mCRC adaptation was approved in June 2020.
it is worth mentioning that Keytruda is the first single-drug anti-PD-1 therapy approved for MSI-H/dMMR mCRC first-line therapy, with the potential to change the treatment pattern of first-line treatment MSI-H mCRC.
May 2017, Keytruda was approved by the FDA to become the first cancer drug based on MSI-H/dMMR biomarkers to treat patients with MSI-H or dMMR solid tumors, regardless of tumor type.
this approval is based on the results of the Key 3 KEYNOTE-177 study.
this study is the first positive head-to-head phase III study comparing single agent anti-PD-1 therapy with standard nursing chemotherapy for first-line treatment of MSI-H or dMMR colorectal cancer.
data show that Keytruda single-drug first-line therapy significantly reduced the risk of disease progression or death by 40% (p-0.0004) and significantly doubled progression-free survival (medium PFS: 16.5 months vs. 8.2 months) compared to current standard nursing chemotherapy (mFOLFOX6 or FOLFIRI, co-use or unlinked beva monoantigen, chosen by the researchers).
the results of the study, published in the New England Journal of Medicine (NEJM), are detailed in Pembrolizumab in Microsatellite-Dess-High Advanced Colorectal Cancer.
colorectal cancer (Photo: medicalnewstoday.com) Colorectal cancer (CRC) is a cancer that is found in the colon or rectum, which is part of the body's digestive or gastrointestinal system.
CRC is the third most common cancer in the world and the second leading cause of cancer-related death.
estimates that there will be nearly 850,000 new cases of CRC confirmed worldwide in 2018, more than 880,000 deaths, and nearly half a million new cases of colorectal cancer in Europe alone.
5-year survival rates for advanced/metastatic colon cancer and rectal cancer (stage IV) were 14% and 15%, respectively.
Microsatellite Instability (MSI) is a change that occurs in the DNA of certain cells, such as tumor cells, in which the number of repetitions (short and repeated DNA sequences) of microsatellites is different from the number of repetitions in DNA at the time of genetics.
the instability of microsatellites may be that the ability to fix errors is flawed when copying DNA in cells.
this defect is also known as a misalmed repair defect (dMMR).
estimated that about 10-15% of CRC patients were tested with a tumor rated MSI-H or dMMR.
dMMR or MSI-H mCRC are less likely to benefit from conventional chemotherapy programs, often with very poor prognostics and low survival rates.
, all CRC patients should be routinely examined for dMMR or MSI-H status.
May 2017, Keytruda was approved by the FDA to become the first cancer drug based on MSI-H/dMMR biomarkers to treat patients with MSI-H or dMMR solid tumors, regardless of tumor type.
keytruda is an anti-PD-(L)1 tumor immunotherapy that helps detect and fight tumor cells by boosting the body's immune system.
Keytruda is an anti-PD-1 therapy that activates T lymphocytes that may affect tumor cells and healthy cells by blocking the interaction between PD-1 and its mediators, PD-L1 and PD-L2.
, Keytruda has been approved to treat a variety of types of cancer.
has been approved for more than 10 anti-PD-(L)1 therapies worldwide, with Keytruda leading the list, with global sales of $11.1 billion in 2019, up 58% from the previous year.
comes after a report by Evaluate Pharma, a pharmaceutical market research group, predicted keytruda would sell $24.91 billion in sales in 2026, making it the world's best-selling drug.
has the largest clinical development program in the industry for immuno-oncology, and more than 1,300 clinical trials are currently investigating Keytruda's role in multiple types of tumors and treatment backgrounds.
Keytruda Clinical Program aims to understand the role of the drug in cancer and the factors that may predict patients to benefit from Keytruda treatment, including exploring several different biomarkers.
() Origin: European Commission approves KEYTRUDA® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Esteline-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer