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On April 2, MSD announced that keytruda first-line treatment microsatellite instability (MSI-H) or mismatchrepair repair defect (dMMR) clinical stage 3 KEYNOTE-177 trial in patients with non-removable or metastatic colorectal cancer had reached a double primary endpoint, no progression survival (PFS).
a mid-term analysis based on the Independent Data Monitoring Board (DMC), Keytruda single drug therapy showed statistically significant and clinically significant PFS improvements compared to chemotherapy (mFOLFOX6 or FOLFIRI, combined or non-combined belaver monoidatis, or cytoxiciform monotomatox).
, as recommended by the DMC, the study will continue without changing another dual primary endpoint and evaluating the total lifetime (OS).
KEYNOTE-177 (NCT02563002) is a randomized, open-label clinical Phase 3 trial that evaluated the efficacy of Keytruda single drug therapy and standard chemotherapy first-line treatment in patients with MSI-H or dMMR advanced colorectal cancer.
double primary endpoints are PFS and OS, and secondary ends are ORR.
the study involved 308 patients and randomly received one of the following treatments: Keytruda (200mg fixed dose, every 3 weeks, up to 35 cycles of treatment for a maximum of about 2 years); xyresatox (400mg/m2 IV, then 250mg/m2, every 2 weeks); FOLFIRI; FOLFIRI-Beval-Bead-Bead editing (5mg/kg IV, 1 day of 1 cycle every 2 weeks); or FOLFIRI-sixito monotol (400mg/m2 IV, then 250mg/m2, every 2 weeks).
colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death in the world.
estimates that there were nearly 850,000 new cases of colorectal cancer worldwide and more than 880,000 deaths from the disease in 2018.
in the United States, there are an estimated 105,000 new cases of colon cancer and more than 43,000 new cases of colorectal cancer, leading to more than 53,000 deaths from colorectal cancer by 2020. The five-year survival rates of late/metastatic colon cancer and rectal cancer (phase IV) in
are estimated to be 14% and 15%, respectively.
colorectal cancer setypes occur in the colon or rectal, which are called colon and rectal cancers, depending on where the cancer occurs.
colorectal cancer often begins to grow on the lining of the colon or rectum called polyps, which can turn into cancer over time.
microsatellite instability (or MSI) is defined by the National Cancer Institute (NCI) as a change in the DNA of certain cells, such as tumor cells, where the number of repetitions of microsatellites (short, repetitive sequences of DNA) differs from the number of repetitions inherited from DNA.
microsatellite instability may be a fault in the repair ability of errors made when copying DNA within cells, also known as mismatch repair defects (dMMR).
estimates, about 10-15% of colorectal cancer patients have a tumor score of MSI-H or dMMR.
Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, activating T lymphocytes and increasing the body's immune system's ability to help detect and fight tumor cells.
May 2017, Keytruda became the first FDA-approved anti-tumor therapy not to distinguish between tumor sources, but biomarkers.
Keytruda has been approved by the FDA for the treatment of cancer patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractive classic Hodgkin lymphoma, or urinary tract skin cancer, and keytruda in China has been approved for first-line treatment of non-small cell lung cancer (NSCLC) and non-removable or metastatic melanoma after first-line treatment.
"These head-to-head data using Keytruda are single-drug anticancer therapies, especially anti-PD-1 monodrug therapy, which for the first time achieved a statistically significant improvement in non-progressive survival PFS in PATIENTs with MSI-H colorectal cancer, including the current standard treatment for mFOLFOX6 combined befamonolita," said Dr. Roy Baynes, senior vice president and head of global clinical development at Mercadon Research Laboratory.
" first-line treatment in the environment, these data provide evidence of further benefits for Keytruda single-drug treatment of patients with MSI-H or dMMR tumors.
we look forward to sharing this data with the medical community and regulators as soon as possible.
" References: Merck Announcs KEYTRUDA ® (Pembrolizumab) Great Erly-Improved Progression-Free Survival as First-Line Treatment for Advanced Advanced Microsio Siounited Instability-High (MSI-H Mismatch) OrficOS (dMMR) Colorectal Cancer. Retrieved 2020-04-02, from the original title: Express. Keytruda first-line treatment of colorectal cancer phase 3 clinical results were positive.