KEYTRUDA (pembrolizumab) - Renal cell carcinoma (RCC)

The Committee deems that the clinical benefit of KEYTRUDA 25 mg/ml (pembrolizumab) in combination with lenvatinib is substantial in the first-line treatment of advanced renal cell carcinoma, only in clear-cell RCC or with a clear-cell component;

Considering:

• evidence of the superiority of the KEYTRUDA (pembrolizumab) + lenvatinib combination compared to sunitinib, considered to be an acceptable comparator at the time of implementation of the KEYNOTE-581 (CLEAR) study, for:
  • progression-free survival assessed by an independent review committee (primary efficacy endpoint): 23.9 months versus median of 9.2 months; HR = 0.39; 95% CI [0.32; 0.49]; p<0.0001,
  • overall survival (ranked secondary endpoint): the median was not reached in either of the two groups; HR=0.66; 95% CI [0.49; 0.88]; p=0.0049,

despite:

• an additional toxicity of this combination compared to sunitinib, particularly in terms of serious adverse events (50.6% vs 33.2%), grade ≥ 3 events (82.4% vs 71.8%) or events leading to discontinuation of treatment (37.4% vs 14.4%),
• exploratory quality of life data,

the Transparency Committee considers that the KEYTRUDA (pembrolizumab) + lenvatinib combination, like the pembrolizumab/axitinib combination and the nivolumab/cabozantinib combination, provides a moderate clinical added value (CAV III) compared to sunitinib in the first-line treatment of advanced clear-cell renal cell carcinoma or with a clear-cell component.