![]() In KEYNOTE‑051, assessment of tumor status was performed every eight weeks for 24 weeks, and then every 12 weeks thereafter. In KEYNOTE‑164 and KEYNOTE‑158, assessment of tumor status was performed every nine weeks through the first year, then every 12 weeks thereafter. Regardless of histology, MSI or MMR tumor status was determined using polymerase chain reaction (local or central) or immunohistochemistry (local or central), respectively.Īdult patients received KEYTRUDA 200 mg administered intravenously every three weeks (pediatric patients received 2 mg/kg every three weeks) until unacceptable toxicity, disease progression or a maximum of 24 months. All trials excluded patients with autoimmune disease or a medical condition that required immunosuppression. ![]() KEYNOTE-051 ( NCT02332668) enrolled seven pediatric patients with MSI-H/dMMR cancers. Patients were either prospectively enrolled with MSI-H/dMMR tumors (Cohort K) or retrospectively identified in one of 10 solid tumor cohorts (Cohorts A-J). KEYNOTE-158 ( NCT02628067 ) enrolled 373 patients with advanced MSI-H/dMMR non-colorectal cancers who had disease progression following prior therapy. KEYNOTE-164 ( NCT02460198) enrolled 124 patients with advanced MSI-H/dMMR colorectal cancer that progressed following treatment with fluoropyrimidine and either oxaliplatin or irinotecan with or without anti-VEGF/EGFR mAb-based therapy. The full approval was based on data from three multicenter, non-randomized, open-label multi-cohort trials. “This milestone reflects Merck’s longstanding commitment to biomarker research and personalizing treatment strategies for patients.” Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. "Today’s approval builds on the 2017 accelerated approval of KEYTRUDA as the first immunotherapy with a tumor agnostic indication and supports the role of KEYTRUDA as an effective immunotherapy option based on a pan-tumor predictive biomarker," said Dr. For more information, see “Selected Important Safety Information” below. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. Early identification and management of immune- mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. “These data also further underscore the need for biomarker testing to identify patients who may be eligible for this therapy.” Diaz, Jr., head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. “This approval reinforces the important role of KEYTRUDA in certain patients with MSI-H or dMMR solid tumors facing a variety of cancers,” said Dr. This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type. The conversion from an accelerated to a full (regular) approval is based on results from the Phase 2 KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials and includes data in 504 adult and pediatric patients across more than 30 types of cancer. Food and Drug Administration (FDA) has granted full approval to KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. RAHWAY, N.J.-( BUSINESS WIRE)-Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S.
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