KEYTRUDA (pembrolizumab) - Gastric or gastro-oesophageal junctionadenocarcinoma

The Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) is substantial in the MA indication.

Considering, on the one hand:

• demonstration in a phase 3, double-blind study of a superiority of KEYTRUDA (pembrolizumab), in combination with trastuzumab, fluoropyrimidine and dual platinum-containing chemotherapy, compared with trastuzumab combined with dual chemotherapy alone, in the ITT population including 85% patients with a CPS ≥ 1 in terms of:
  • overall survival: HR = 0.80 (CI95% [0.67; 0.94]) with a difference in median of +3.2 months;
  • progression-free survival: HR = 0.73 (CI95% [0.61; 0.87]) with a difference in median of +1.9 months;

but, on the other hand:

• the absence of robust data on quality of life,
• an effect size judged to be modest in terms of progression-free survival and overall survival,
• its safety profile marked, in particular by immune-mediated adverse effects,

the Transparency Committee deems that KEYTRUDA (pembrolizumab), in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, as first-line treatment for locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 provides a minor clinical added value (CAV IV) compared to platinum-containing chemotherapy and fluoropyrimidine.