KEYTRUDA (pembrolizumab) - Adjuvant renal cell carcinoma

The Committee deems that the clinical benefit of KEYTRUDA 25 mg/ml concentrate for solution for infusion is substantial only in the adjuvant treatment in adults with clear-cell renal cell carcinoma, at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesionsin the MA indication.

• In clear-cell renal cell carcinoma:

Considering:

• evidence of superiority of pembrolizumab versus placebo on the primary endpoint, investigator-assessed recurrence-free survival, with HR = 0.68 CI95%: [0.53 - 0.87], p=0.0010;
• evidence of superiority of pembrolizumab versus placebo on the ranked secondary endpoint, overall survival, with, at the third interim analysis, HR = 0.62 CI95%: [0.44 - 0.87], p=0.0024;
• excess toxicity in the pembrolizumab group, marked in particular by adverse events of grade 3 or more (32.0% and 17.7% in the placebo group) and serious adverse events (20.7% and 11.5%);
• the absence of a demonstrated impact on quality of life (exploratory endpoint);

the Committee considers that as the dossier currently stands, KEYTRUDA (pembrolizumab) provides a moderate clinical added value (CAV III) as monotherapy in the adjuvant treatment of adults with clear-cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.