KEYNOTE-590: 5-Year outcomes confirm benefit of pembrolizumab in oesophageal cancer

The 5-year data of the KEYNOTE-590 study demonstrate that the addition of pembrolizumab to chemotherapy continues to improve overall survival (OS) in patients with advanced oesophageal cancer. No new safety issues were documented, confirming that chemotherapy plus pembrolizumab is the standard-of-care first-line therapy for this population.

The phase 3 KEYNOTE-590 study (NCT03189719) randomised 749 participants with advanced oesophageal cancer 1:1 to pembrolizumab plus chemotherapy or to placebo plus chemotherapy. The primary results displayed a clear efficacy benefit for participants in the pembrolizumab group [1]. Now, Prof. Manish Shah (Weill Cornell Medicine, NY, USA) presented the 5-year outcomes of the trial [2].

“Pembrolizumab added to chemotherapy continued to display a benefit in OS compared with chemotherapy plus placebo, with 5-year OS rates of 10.6% and 3.0%,” said Prof. Shah. The median OS was 12.3 months in the experimental arm and 9.8 months in the control arm (HR 0.72; 95% CI 0.62–0.84). This result was consistent in the subpopulations of participants with a combined positive score (CPS) ≥10 (n=383) and those with squamous cell carcinomas (n=549). Furthermore, the median progression-free survival was 6.3 months in the pembrolizumab arm and 5.8 months in the placebo arm (HR 0.64; 95% CI 0.54–0.75). “We also noticed numerical benefits in patients on pembrolizumab with respect to dysphagia, pain, and reflux,” mentioned Prof. Shah.

There were no substantial differences in the safety profiles of the 2 treatment regimens, according to Prof. Shah. However, immune-mediated adverse events and infusion reactions appeared to occur somewhat more frequently in the pembrolizumab arm (27.3% vs 15.7%).

Overall, the 5-year results of KEYNOTE-590 continue to support the use of pembrolizumab plus chemotherapy as first-line therapy in patients with advanced oesophageal cancer.

1. Sun JM, et al. Lancet. 2021;398(10302):759-771.
2. Shah MA, et al. First-line pembrolizumab plus chemotherapy for advanced esophageal cancer: 5-year outcomes from the phase 3 KEYNOTE-590 study. Abstract 250, ASCO Gastrointestinal Cancers Symposium 2024, 18–20 January, San Francisco, CA, USA.

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Posted on 13 February 202421 May 2024