Colorectal cancer precision medicine! Mercado Keytruda has been approved by the FDA for single-drug first-line treatment of MSI-H/dMMR patients and will change treatment patterns.

, June 30, 2020 /
bio-valley,-- Merck and Co recently announced that the U.SFood and Drug Administration (
FDA) has approved the anti-PD-1 therapy Keytruda (Corrida, generic name: pe Mbrolizumab, Paboli Zumab, as a monodrug therapy, first-line treatment of patients with high microsatellite instability (MSI-H) or mismatched repair defects (dMMR), non-removability or metastatic colorectal cancer (mCRC)noteworthy, Keytruda is the first single drug anti-PD-1 therapy approved for first-line treatment in MSI-H/dMMR mCRC patients, and has the potential to change the treatment patterns of first-line treatment for patients with MSI-H colorectal cancerAccording to the results of the KEYNOTE-177 study, less than a month after the submission of the Supplemental Biologics Permit Application (sBLA), it was approved by theFDAMay 2017, Keytruda wasin the United StatesThe FDAapproved, becoming the first anti-cancer drug based on MSI-H/dMMRbiomarkerto treat patients with MSI-H or dMMR solid tumors, regardless of the type oftumorthis latest approval is based on the results of the Key III KEYNOTE-177 study It is worth mentioning that this study is the first positive head-to-head III study comparing single-formulation anti-PD-1 therapy with standard care chemotherapy for first-line treatment of MSI-H or dMMR colorectal cancer The data show that Keytruda single drug therapy significantly reduces the risk of disease progression or death by 40% compared to current standard care (SOC) chemotherapy (mFOLFOX6 or FOLFIRI, co-use or non-combination of belavite mesometidasis, selected by researchers) (HR-0.60 .95% CI:0 45-0.80? ;p, more than double the median progression-free survival (PFS) (16.5 months (95% CI: 5.4-32.4) vs 8.2 months (95% CI: 6.1-10.2) Dr Roy Baynes, Senior Vice President and Director of Global Clinical Development at 's Mercadon Research Laboratory, said, "Based on the important findings of the KEYNOTE-177 study, today's approval has the potential to change the treatment patterns of first-line treatment in patients with MSI-H colorectal cancer, and the results of this study show that Keytruda monotherapy has a higher progression-free survival than standard chemotherapy Our ongoing commitment to biomarkers research will continue to help us bring new treatments to patients, especially those with few options available "
KEYNOTE-177 (NCT02563002) is a randomized, open-label Phase III trial in which 307 patients with MSI-H or dMMR, non-excision or metastatic CRC were enrolled In the study, these patients were randomly assigned to receive one of the six SOC chemotherapy regimens selected by the researchers (mFOX6; mFOX46; mFOLFOX6; folfirI; FOLFIRI, FOLFIRI, befivalium; FOLFIRI, folifi, and befivalssie, folifi, and sepsis, and folifi results showed that Keytruda's first-line treatment significantly reduced the risk of disease progression or death by 40% compared to chemotherapy (HR-0.60; 95% CI: 0.45-0.80; p-0.0002), and progression-free survival was doubled (median PFS: 16.5 months vs 8.2 months) Keytruda had a two-year no-progress survival rate of 48% and chemotherapy group 19% The total remission rate (ORR) of keytruda and chemotherapy groups was 43.8%, 33.1%, total remission (CR) was 11.1% and 3.9%, respectively, and the partial mitigation rate (PR) was 32.7% and 29.2%, respectively The median duration of the keytruda group (DOR) has not yet been reached (range: 2.3 to 41.4 plus) and the chemotherapy group is 10.6 months (range: 2.8 to 37.5 plus) In addition, 83 percent of patients in the Keytruda group had remission lasting at least 2 years, while the chemotherapy group had 35 percent In the study, 59% of the intended treatment population received subsequent anti-PD-1/PD-L1 treatment after discontinuing the chemotherapy group's research treatment the study, Keytruda's safety analysis showed that the incidence of adverse events (TRAE) associated with grade 3 treatment was lower than in the chemotherapy group (22% vs 66%), and no new toxic reactions were observed The incidence of immune-mediated adverse reactions and infusion reactions was 31% in keytruda treatment group and 13% in the chemotherapy group The most commonly reported immune mediated adverse events were in the Keytruda group for hypothyroidism (12%) and colitis (7%) and chemotherapy group for infusion reaction (8%) , as recommended by the Independent Data Monitoring Committee (DMC), the study will proceed withnosis to assess the total lifetime (OS) of one of the two main endpoints colorectal cancer (CRC) is a cancer that is located 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 It is estimated that nearly 850,000 new cases of CRC were confirmed worldwide in 2018 and more than 880,000 deaths were reported In 2020, the United States is expected to confirm 105,000 new cases of colon cancer and 43,000 new cases of colorectal cancer, and 53,000 deaths from colorectal cancer The five-year survival rates of advanced/metastatic colon cancer and rectal cancer (phase IV) were 14% and 15%, respectively Microsatellite instability (MSI) is a change in the DNA of certain cells, such as tumor cells, defined by the U.S National Cancer Institute (NCI), in which the number of repetitions of microsatellites (short and repeated DNA sequences) differs from the number of repetitions in DNA in genetic The reason for the instability of microsatellites may be a flaw in the ability to fix errors when DNA is copied in cells This defect is also known as mismatch repair defect (dMMR) It is estimated that about 10-15% of CRC patients tumor rated MSI-H or dMMR during testing patients with dMMR or MSI-H mCRC are less likely to benefit from conventional chemotherapy regimens, usually with very poor prognosis and low survival rates Therefore, all CRC patients should be subjected to routine checks for dMMR or MSI-H status in May 2017, Keytruda received a U.S The FDA approved as the first anticancer drug based on MSI-H/dMMR biomarker for the treatment of patients with MSI-H or dMMR solid tumors, regardless of the type of tumor Keytruda is a PD-(L) 1 tumor immunotherapy that helps detect and fight tumor cells by boosting the body's immune system Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells So far, 11 PD-(L) 1 oncology immunotherapy have been approved worldwide, of which Keytruda is the leader in the field, with more than 20 therapeutic indications approved and global sales reaching $11.1 billion in 2019, up 58% from the previous year Mercado has the largest clinical development of immunothologists in the industry, with more than 1,200 clinical trials
investigating Keytruda's role in a variety of types of tumor and therapeutic context The Keytruda Clinical Project aims to understand the drug's role in cancer and factors that may predict patients' benefits from Keytruda treatment, including exploring several different biomarker (BioValleyBioon.com) original source: FDA Approves Merck's keytruDA ® (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer .