7/19/2023 0 Comments Msi laptop service centre near me![]() “These data also further underscore the need for biomarker testing to identify patients who may be eligible for this therapy.”Ī total of 124 patients with advanced MSI-H/dMMR colorectal cancer (CRC) what progressed after fluoropyrimidine and oxaliplatin or irinotecan with or without a VEGF/EGFR monoclonal antibody–based therapy were enrolled to KEYNOTE-164. Diaz, Jr., MD, head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, stated in a press release. “This approval reinforces the important role of KEYTRUDA in certain patients with MSI-Hor dMMR solid tumors facing a variety of cancers,” Luis A. The regulatory decision represents the first full approval for an immunotherapy agent based on a predictive biomarker, irrespective of solid cancer type, according to a press release issued by Merck. ![]() The median duration of response (DOR) was 63.2 months (range, 1.9+ to 63.9+). More than half (77%) of those who responded to the agent (n = 168) experienced responses that lasted for at least 12 months 39% responded for 36 months or longer. ![]() The conversion to a regular approval was supported by findings from the multicenter, non-randomized, open-label, multicohort, phase 2 KEYNOTE-158 (NCT02628067), KEYNOTE-164 (NCT02460198), and KEYNOTE-051 (NCT02332668) trials and comprises data from 504 adult and pediatric patients with over 30 kinds of cancer.ĭata from a pooled analysis of the trials showed that at a median follow-up of 20.1 months (range, 0.1-71.4), pembrolizumab elicited an objective response rate (ORR) of 33.3% (95% CI, 29.2%-37.6%), which comprised a 10.3% complete response rate and a 23.0% partial response rate. ![]() The FDA has granted full approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment and who have no satisfactory alternative options.
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