KEYTRUDA (pembrolizumab) - Gastric or gastro-oesophageal junctionadenocarcinoma
Opinions on drugs -
Posted on
Nov 21 2024
Reason for request
Indication extension
Summary of opinion
Favourable opinion for reimbursement in the indication “in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junctionadenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) is substantial in the MA indication.
Clinical Added Value
minor
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.