KEYTRUDA (pembrolizumab) - Gastro-oesophageal junction adenocarcinoma

The Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) 25 mg/ml, is substantial in combination with fluoropyrimidine and platinum-based chemotherapy in the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10.

Considering:

• demonstration in a phase 3, double-blind study of a superiority of KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine and platinum-based chemotherapy compared with chemotherapy alone in patients whose tumours express PD-L1 with a CPS ≥ 10 in terms of:
  • overall survival: HR = 0.65 (95% CI [0.53; 0.79]; p< 0.0001);
  • progression-free survival: HR = 0.62 (95% CI [0.51; 0.76]; p< 0.0001)

and despite:

• a safety profile of KEYTRUDA (pembrolizumab) in combination with chemotherapy that is less favourable than that of chemotherapy alone, marked, in particular, by immune-mediated adverse effects (primarily dysthyroidism),
• the absence of robust data on quality of life,

the Transparency Committee deems that KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine and platinum-based chemotherapy in the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10 provides a moderate clinical added value (CAV III) compared to chemotherapy alone, in the same way as OPDIVO (nivolumab