- #Keynote 158 clinical trials.gov skin
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- #Keynote 158 clinical trials.gov trial
O’Malley of the Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center in Columbus, OH, US and colleagues on 6 January 2022 in the Journal of Clinical Oncology.Īpproximately 25% to 31% of patients with endometrial cancer have MSI-H/dMMR tumours. Efficacy and safety data in a larger number of patients and longer follow-up from the study are published by Dr. Findings from the KEYNOTE-158 study support the use of pembrolizumab as a treatment option for patients with advanced MSI-H/dMMR endometrial cancer with treatment failure on prior therapy. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-80.Pembrolizumab demonstrated durable antitumour activity with manageable toxicity in patients with advanced microsatellite instability–high (MSI-H) or mismatch repair–deficient endometrial cancer (dMMR). This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
#Keynote 158 clinical trials.gov full
View full prescribing information for Keytruda. The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months.
#Keynote 158 clinical trials.gov skin
Immune-mediated side effects are also associated with pembrolizumab these include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions. The most common adverse reactions (≥20%) occurring in patients were fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritis, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism.
Median DoR was not reached (2.9, 55.7+), with 68% having response durations ≥12 months and 44% having response durations ≥24 months. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DoR) as assessed by blinded independent central review according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Patients treated with pembrolizumab without disease progression could be treated for up to 24 months. Patients received pembrolizumab 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression. MSI or MMR tumor status was determined using polymerase chain reaction or immunohistochemistry, respectively.
#Keynote 158 clinical trials.gov trial
The FDA previously approved the FoundationOne CDx (F1CDx, Foundation Medicine, Inc.) as a companion diagnostic device to select patients with MSI-H in solid tumors that are eligible for treatment with pembrolizumab.Įfficacy was evaluated in KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label, multi-cohort trial in 90 patients with unresectable or metastatic MSI-H or dMMR endometrial carcinoma in Cohorts D and K. Today, the FDA also approved the VENTANA MMR RxDx Panel (Ventana Medical Systems / Roche Tissue Diagnostics) as a companion diagnostic device to select patients with dMMR in solid tumors that are eligible for treatment with pembrolizumab. On March 21, 2022, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
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