Notably, patients were prospectively enrolled with MSI-H dMMR tumors to cohort K or retrospectively identified in 1 of 10 solid tumor cohorts (cohorts A-J). For KEYNOTE-158, 373 patients with advanced MSI-H/dMMR non-CRC who progressed after previous treatment were included.
“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. In 2017, pembrolizumab was granted accelerated approval as the first immunotherapy with a tumor-agnostic indication. 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. This article originally appeared on OncLive.
0 kommentar(er)
