![]() It was the first time a PD-1 inhibitor demonstrated survival improvement in this patient population. Pembrolizumab in combination with chemotherapy previously demonstrated an OS benefit in patients with advanced or metastatic esophageal cancer with who had positive PD-L1 expression in the phase 3 KEYNOTE-181 clinical trial. All agents in the study were administered intravenously. Cisplatin in both study arms is administered at a dose level of 50 mg/m2 on day 1 of each 3-week cycle for up to 6 cycles, and 5-FU was administered at 800 mg/m2 per day on day 1 to day 5 of each 3-week cycle for up to 35 cycles. Patients in the pembrolizumab arm receive the drug at 200 mg on day 1 of each 3-week cycle, for up to 35 cycles. Duration of response and safety are 2 additional secondary end point of the study. ![]() KEYNOTE-590 is a randomized, double-blind, phase 3 clinical trial which is investigating the efficacy and safety of pembrolizumab in combination with the chemotherapy regimen of cisplatin plus 5-fluorouracil (5-FU) compared with placebo plus chemotherapy in 749 patients with locally advanced or metastatic esophageal carcinoma (NCT03189719). These results build upon our research reinforcing the survival benefits of Keytruda, and we look forward to engaging regulatory authorities as quickly as possible.” “In this pivotal study, Keytruda plus chemotherapy resulted in superior overall survival compared with the current standard of care in the full study population and across all patient groups evaluated. “Esophageal cancer is a devastating malignancy with a high mortality rate and few treatment options in the first-line setting beyond chemotherapy,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The safety profile observed in the study was consistent with a prior analysis of KEYNOTE-590.Īs of result of the positive data, the results have been submitted for presentation at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020. In addition, a key secondary end point, objective response rate (ORR), was also met with the combination of pembrolizumab and chemotherapy. 1Īccording to the independent Data Monitoring Committee, the results were both statistically significant and clinically meaningful. The primary end point of the phase 3 KEYNOTE-590 trial was met when the combination of pembrolizumab (Keytruda) and chemotherapy improved overall survival (OS) and progression-free survival (PFS) as initial treatment of patients with locally advanced or metastatic esophageal cancer during an interim analysis of the study, Merck announced in a press release.
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