![]() Prespecified primary end points included OS in all patients, in patients with ESCC who have PD-L1 CPS 10 or higher, patients with ESCC, and in patients with PD-L1 CPS 10 or higher, as well as PFS (per RECIST v1.1 investigator assessment) in all patients, patients with ESCC, and those with PD-L1 CPS 10 or higher. In the control group, the median age was 62.0 years (range, 27-89) 84.8% of participants were male, and 52.4% had PD-L1 CPS greater than or equal to 10. In the experimental group, the median age was 64.0 years (range, 28-94) 82.0% of participants were male, and 49.9% had PD-L1 combined positive score (CPS) greater than or equal to 10. The data cutoff date was July 9, 2020, and the median follow-up was 34.8 months. In the control group, 5 have completed therapy and 365 have discontinued treatment. ![]() In the experimental group, there is still 1 patient who is continuing treatment 33 patients have completed therapy, and 336 patients have discontinued therapy. ![]() Chemotherapy consisted of 5-fluouroacil at 800 mg/m2 intravenously (IV) for days 1 to 5 every 3 weekends for 35 or fewer cycles plus cisplatin at 80 mg/m2 IV every 3 weeks for 6 or fewer cycles. Overall, 749 treatment-naïve patients with locally advanced and metastatic esophageal cancer-including GEJ adenocarcinoma-were randomly assigned to receive either pembrolizumab plus chemotherapy or placebo plus chemotherapy, with 370 patients on each arm. The approval is based on earlier findings from the KEYNOTE-590 trial. In March 2021, the FDA approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation. “These longer-term data further support first-line pembrolizumab plus chemotherapy as a new standard of care in patients with locally advanced and metastatic esophageal cancer, including GEJ adenocarcinoma,” Jean-Phillipe Metges, MD, MSc, CHRU de Brest - Hôpital Morvan, in France, said during a presentation of the findings. The 1-year PFS rates were 25% with pembrolizumab/chemotherapy and 12% with chemotherapy the 2-year PFS rates were 12% and 3%, respectively.įurthermore, quality of life (QOL) as reported to be similar between the 2 groups and no new safety signals were detected with the experimental treatment. The median progression-free survival (PFS) across all patients was 6.3 months with pembrolizumab/chemotherapy and 5.8 months with chemotherapy alone (HR, 0.64 95% CI, 0.55-0.75). ![]() The 1-year OS rates were 51% and 39% with pembrolizumab/chemotherapy and chemotherapy alone, respectively 2-year OS rates were 26% and 16%, respectively. In an overall survival (OS) analysis of all evaluable patients, those who received the experimental regimen achieved a median OS of 12.4 months vs 9.8 months among those who received chemotherapy (HR, 0.73 95% CI, 0.63-0.86). The data were from an additional 12 months of follow-up. ![]() The KEYNOTE-590 study (NCT03189719) found patients in all subgroups at the 12-month follow-up with esophageal cancer and gastroesophageal junction (GEJ) adenocarcinoma treated with first-line pembrolizumab (Keytruda) plus chemotherapy yielded a clinical benefit, according to a presentation from the 2022 Gastrointestinal Symposium. ![]()
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