Pembrolizumab regimen extends survival in advanced esophageal cancer
The addition of pembrolizumab to first-line chemotherapy extended OS and PFS among patients with locally advanced or metastatic esophageal cancer, according to the agent’s manufacturer.
Researchers also reported a significantly higher objective response rate among patients assigned the combination.
Esophageal cancer is difficult to treat, and few first-line treatment options exist beyond chemotherapy.
The randomized phase 3 KEYNOTE-590 trial included 749 patients with locally advanced or metastatic esophageal carcinoma.
Researchers randomly assigned patients to standard first-line chemotherapy — cisplatin plus 5-FU — plus either the anti-PD-1 therapy pembrolizumab (Keytruda, Merck), dosed at 200 mg via IV on day 1 of each 3-week cycle, or placebo. Treatment continued for up to 35 cycles.
OS and PFS served as primary endpoints. Secondary endpoints included ORR, duration of response and safety.
Results of an interim analysis conducted by an independent data monitoring committee showed significantly improved OS and PFS among patients in the intention-to-treat population assigned the pembrolizumab-chemotherapy combination.
The combination also exhibited a safety profile consistent with that observed in prior studies of pembrolizumab.
Complete results will be shared with regulatory authorities and submitted for presentation at this year’s European Society for Medical Oncology Virtual Congress.
Pembrolizumab is approved in the United States for treatment of certain patients with multiple malignancies, including lung cancer, head and neck squamous cell carcinoma, melanoma, hepatocellular carcinoma, classical Hodgkin lymphoma, gastric cancer and cervical cancer.