NICE: Pembrolizumab for Advanced Oesophageal or Gastro-Oesophageal Junction Cancer

Dawn O'Shea

October 25, 2021

NICE has issued final guidance which recommends pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy as a first-line option for untreated locally advanced unresectable or metastatic oesophageal cancer or HER2‑negative gastro-oesophageal junction adenocarcinoma in patients with PD‑L1-positive tumours and a combined positive score (CPS) of ≥10.

After a review of the evidence, an expert appraisal committee has determined that pembrolizumab meets NICE's criteria to be considered a life-extending treatment at the end of life.

The recommendation is based on findings from the randomised, double-blind, placebo-controlled trial KEYNOTE‑590 (n=749), which compared cisplatin and fluorouracil, with or without pembrolizumab, as first-line treatment for locally advanced unresectable or metastatic oesophageal adenocarcinoma, squamous cell carcinoma or advanced gastro-oesophageal junction adenocarcinoma. The trial recruited participants from 26 countries, including the UK.

For people with a CPS of ≥10, KEYNOTE‑590 reported a median progression-free survival of 7.5 months in the pembrolizumab plus chemotherapy arm and 5.5 months in the placebo plus chemotherapy arm (hazard ratio [HR] 0.51; 95% CI 0.41-0.65; P<.001). The corresponding median overall survival for pembrolizumab plus chemotherapy was 13.5 months and 9.4 months for the placebo plus chemotherapy arm (HR 0.62; 95% CI 0.49-0.78; P<.001).

This article originally appeared on Univadis, part of the Medscape Professional Network.

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