Colorectal cancer precision medicine! Mersadon Keytruda first-line treatment of MSI-H/dMMR patients head-to-head Phase III efficacy beats standard chemotherapy!

May 30, 2020 /
PRNewswire
BIOON/-- Merck and Co recently released positive results for the first time in the key phase III KEYNOTE-177 studyThe study is evaluating the anti-PD-1 therapy Keytruda (Corida, generic name: pembrolizumab, Pablozumab, Pablozumab) as a single-drug therapy, first-line treatment of patients with high microsatellite instability (MSI-H) or mismatch repair defects (dMMR), non-reprecyllive or metastatic colorectal cancer (mCRC)results showed that Keytruda monotherapy significantly reduced the risk of progression or death by 40 percent and more than doubled the risk of progression or death (PFS) compared to current standard nursing (SOC) chemotherapy (mFOLFOX6 or FOLFIRI, combined or non-co-used beiramono or citoxia, selected by researchers)it is worth mentioning that KEYNOTE-177 is the first positive head-to-head phase III trial for the use of first-line treatment of MSI-H or dMMR colorectal cancer in the first-stage treatment of a single formulation of anti-PD-1 therapy and standard nursing chemotherapyMay 2017, Keytruda was awarded the U.SThe FDA approvedto become the first anticancer drug based on MSI-H/dMMRbiomarkerfor the treatment of patients with MSI-H-H or dMMR solid tumors, regardless of the type oftumorKEYNOTE-177 (NCT02563002) is a randomized, open label Phase III trial that enrolled 307 patients with MSI-H or dMMR, non-rectructible or metastatic CRCIn the study, these patients were randomly assigned to receive Keytruda (200 mg intravenously every 3 weeks, up to 35 courses) or one of the six SOC chemotherapy options selected by the researchers (mFOLFOX6; mFOLFOX6 plus bevamonota, mFOLFOX6 and sitosipen resistance; FOLFIRI; FOLFIRI AND Bistosin; FOLIFIR sitosiresults showed that Keytruda single-line treatment significantly reduced the risk of progression or death by 40% compared to chemotherapy (HR: 0.60; 95% CI: 0.45-0.80; p-0.0002), double the progression-free survival (median PFS: 16.5 months vs8.2 months) The 2-year progression survival rate in the Keytruda group was 48% and the chemotherapy group was 19% The total remission rate (ORR) was 43.8% and 33.1% in the Keytruda group and 33.1% in the chemotherapy group, 11.1% and 3.9% in the total remission rate (CR), and 32.7% and 29.2% in partial remission (PR), respectively The median remission duration (DOR) in the Keytruda group was not yet reached (range: 2.3 to 41.4 plus) and 10.6 months in the chemotherapy group (range: 2.8 to 37.5 plus) In addition, 83% of patients in the Keytruda group had remission symoldering for at least 2 years and 35% in the chemotherapy group In the study, 59 percent of the intended treatment population received subsequent anti-PD-1/PD-L1 treatment after discontinuing the study of chemotherapy group the study, Keytruda's safety analysis showed that the incidence of treatment-related adverse events (TRAE) in the level 3 was lower than that of the chemotherapy group (22 percent vs 66 percent) and no new toxic reactions were observed Immune-mediated adverse reactions and infusion reactions, with 31% incidence in keytruda treatment groups and 13% in chemotherapy groups The most commonly reported immunomediated adverse events were in the Keytruda group with hypothyroidism (12%) and colitis (7%), and chemotherapy group was infusion (8%) , on the recommendation of the Independent Data Monitoring Committee (DMC), the study will continue without any changes to assess the total lifetime (OS) of one of the two main endpoints "For many years, the standard of care for first-line treatment for PATIENTS WITH MSI-H colorectal cancer has been a combination of mFOLFOX6 and beva monoantigen," said Dr Roy Baynes, Senior Vice President, Chief Medical Officer and Head of Global Clinical Development, 's Mercado Research Laboratory For the first time, a single-drug anti-PD-1 therapy showed a statistically significant improvement in the progression of these patients compared to chemotherapy In first-line treatment, patients with MSI-H colorectal cancer have significantly unmet medical needs for new treatments that provide sustained, long-term improvement We appreciate the opportunity to announce these results at this year's ASCO meeting , which will change clinical practice Dr Thierry Andre, M.D., Professor of Medical Oncology at the University of Sorbonne in France and Head of the Department of
Oncology at St Anthony's Hospital, said: "Keytruda single-line treatment significantly reduced the risk of disease progression or death in patients with MSI-H metastatic colorectal cancer, reduced by 40 percent compared to standard chemotherapy, and observed fewer adverse events associated with treatment Keytruda also showed long-term, long-lasting remission, which lasted more than 2 years in patients who responded to treatment Data from the KEYNOTE-177 study show that Keytruda monotherapy has the potential to become a new standard of care for patients with MSI-H metastatic colorectal cancer "
colorectal cancer (CRC) is a cancer with a disease in the color 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 have been confirmed globally and more than 880,000 deaths have been confirmed worldwide in 2018 By 2020, the United States is expected to confirm 105,000 new cases of colon cancer and 43,000 new cases of rectal cancer, and 53,000 people to die from colorectal cancer The five-year survival rates for advanced/metastatic colon 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 National Cancer Institute (NCI), in which the number of repetitions (short, repeated DNA sequences) of microsatellites is different from the number of repetitions in DNA during genetic The cause of microsatellite instability may be a flawed ability to repair errors when copying DNA 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 when tested Patients with dMMR or MSI-H mCRC are less likely to benefit from routine chemotherapy regimens, often with very poor prognosis and low survival rates Therefore, all CRC patients should be routinely examined for dMMR or MSI-H status in May 2017, Keytruda was awarded the U.S Fda approved to become the first anticancer drug based on MSI-H/dMMR biomarker for the treatment of patients with MSI-H-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 improving the body's immune system Keytruda is a human-derived 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-1 of cancer immunotherapy have been approved worldwide, with Keytruda as the leader in the field, with more than 20 therapeutic indications approved, and global sales reached $11.1 billion in 2019, up 58% from the previous year with the largest clinical development of immuno-oncology in the industry, Mercado, there are more than 1,200 clinical trials investigating Keytruda's role in multiple types of tumor and treatment background The Keytruda Clinical Project aims to understand the role of the drug in cancer and the factors that may predict patients will benefit from Keytruda treatment, including exploring several different biomarker (biovalleybioon.com) original source: Merck's KEYTRUDa ® (pembrolizumab) to Standard of Care Newsy in Patients with MSI-H Colorectal Cancer