In KEYNOTE‑051, assessment of tumour status was performed every eight weeks for 24 weeks, and then every 12 weeks thereafter. In KEYNOTE‑164 and KEYNOTE‑158, an assessment of tumour status was performed every nine weeks through the first year, then every 12 weeks thereafter. Regardless of histology, MSI or MMR tumour status was determined using polymerase chain reaction (local or central) or immunohistochemistry (local or central), respectively.Īdult patients received pembrolizumab 200 mg administered intravenously every three weeks (paediatric patients received 2 mg/kg every three weeks) until unacceptable toxicity, disease progression or a maximum of 24 months. KEYNOTE-051 (NCT02332668) enrolled seven paediatric patients with MSI-H/dMMR cancers.Īll trials excluded patients with autoimmune disease or a medical condition that required immunosuppression. Patients were either prospectively enrolled with MSI-H/dMMR tumours (Cohort K) or retrospectively identified in one of 10 solid tumour 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-randomised, open-label multi-cohort trials. “This milestone reflects Merck’s longstanding commitment to biomarker research and personalising treatment strategies for patients.” "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-tumour predictive biomarker," said Dr Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. For more information, see “Selected Important Safety Information” below. Based on its mechanism of action, pembrolizumab can cause foetal harm when administered to a pregnant woman. Pembrolizumab can also cause severe or life-threatening infusion-related reactions. Early identification and management of immune- mediated adverse reactions are essential to ensure the safe use of pembrolizumab.īased on the severity of the adverse reaction, pembrolizumab should be withheld or permanently discontinued and corticosteroids administered if appropriate. 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 pembrolizumab, 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 pembrolizumab in certain patients with MSI-Hor dMMR solid tumours facing a variety of cancers,” said Dr Luis A. This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumour 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 paediatric patients across more than 30 types of cancer. FDA has granted full approval to pembrolizumab, an anti-PD-1 therapy, for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
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