This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting". These cookies do not store any personal information.Ĭookielawinfo-checkbox-advertising-targeting This category only includes cookies that ensures basic functionalities and security features of the website. Necessary cookies are absolutely essential for the website to function properly. It is estimated approximately up to 20 percent of colorectal cancer patients have tumours that are MSI-H or dMMR. Worldwide, it is estimated there were more than 1,930,000 new cases of colorectal cancer in 2020, with nearly 520,000 occurring in Europe. About colorectal cancer in EuropeĬolorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death worldwide. The cause of MSI may be a defect in the ability to repair mistakes made when DNA is copied in the cell known as mismatch repair deficiency (dMMR). MSI is a change that occurs in the DNA of certain cells, such as tumour cells, in which the number of short, repeated sequences of DNA called microsatellite repeats is different from the number of repeats that was in the DNA when it was inherited. Based on 67 patients with a response in the KEYTRUDA arm and 51 patients with a response in the chemotherapy arm, 85 percent in the KEYTRUDA arm had a DOR greater than or equal to 12 months versus 44 percent in the chemotherapy arm.Ībout microsatellite instability-high (MSI-H) Median DOR was not reached with KEYTRUDA versus 10.6 months with chemotherapy.The ORR of those on chemotherapy was 33 percent, with a complete response rate of four percent and a partial response rate of 29 percent. For patients treated with KEYTRUDA, the ORR was 44 percent, with a complete response rate of 11 percent and a partial response rate of 33 percent.Additional efficacy outcome measures were objective response rate (ORR) and duration of response (DOR). The main efficacy outcome measures were PFS and overall survival (OS). Patients randomised to chemotherapy were offered KEYTRUDA at the time of disease progression. Those treated with KEYTRUDA without disease progression could be treated for up to 24 months. Treatment with KEYTRUDA or chemotherapy continued until the disease progressed or patients experienced unacceptable toxicity. Patients were randomized 1:1 to receive KEYTRUDA (200 mg intravenously) every three weeks or investigator’s choice of the following chemotherapy regimens given intravenously every two weeks. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible.
#Keynote 177 trial#
KEYNOTE-177 was a multi-centre, randomised, open-label, active-controlled trial that enrolled 307 patients with previously untreated metastatic MSI-H or dMMR colorectal cancer. Following Brexit this approval is also valid in Great Britain.
#Keynote 177 plus#
The approval allows marketing of KEYTRUDA monotherapy in all 27 European Union (EU) member states plus Iceland, Lichtenstein, Norway and Northern Ireland. “With this approval, patients with metastatic colorectal cancer that is MSI-H or dMMR status will gain a monotherapy treatment option that has shown superior progression-free survival compared to standard of care chemotherapy.” Antoine Hospital, Assistance Publique Hôpitaux de Paris, both French. “Before the KEYNOTE-177 trial, conventional chemotherapy with targeted therapy was the standard of care for patients with metastatic colorectal cancer who have tumours that are MSI-H/dMMR,” explained Dr Thierry Andre, professor of medical oncology at Sorbonne University and head of the medical oncology department at St. The treatment also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months versus 8.2 months). In addition, there was a lower incidence of Grade 3 or higher treatment-related adverse events (TRAEs) with KEYTRUDA compared with chemotherapy (22 percent versus 66 percent), and no new toxicities were observed. The approval is based on results from the Phase III KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40 percent, compared with chemotherapy. This approval marks the first gastrointestinal indication for KEYTRUDA in Europe and makes it the first anti-PD-1/L1 therapy approved in Europe for these patients. The European Commission (EC) has approved KEYTRUDA, Merck/MSD’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.
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