Pembrolizumab plus chemotherapy vs chemotherapy alone for first-line treatment of advanced esophageal cancer (KEYNOTE-590): A randomised, placebo-controlled, phase 3 study
The Lancet Sep 01, 2021
Sun JM, Shen L, Shah MA, et al. - Improved outcomes were achieved with pembrolizumab plus chemotherapy vs placebo plus chemotherapy in first-line treatment of advanced esophageal cancer and Siewert type 1 gastro-esophageal junction cancer. A manageable safety profile was displayed by pembrolizumab plus chemotherapy in the total as-treated population.
This was a randomized, placebo-controlled, double-blind, phase 3 study in 26 countries.
Patients (n = 749) with previously untreated locally advanced esophageal cancer or Siewert type 1 gastro-esophageal junction cancer were included.
They were randomized to pembrolizumab plus chemotherapy (n=373 [50%]) or placebo plus chemotherapy (n=376 [50%]).
Pembrolizumab plus chemotherapy improved overall survival than placebo plus chemotherapy in patients with esophageal squamous cell carcinoma and PD-L1 combined positive score (CPS) of 10 or more, esophageal squamous cell carcinoma (12·6 months vs 9·8 months), PD-L1 CPS of 10 or more (13·5 months vs 9·4 months), and in all randomized patients (12·4 months vs 9·8 months).
Pembrolizumab plus chemotherapy also improved progression-free survival, vs placebo plus chemotherapy, in patients with esophageal squamous cell carcinoma (6·3 months vs 5·8 months), PD-L1 CPS of 10 or more (7·5 months vs 5·5 months), and in all randomized patients (6·3 months vs 5·8 months).
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