Favourable opinion for reimbursement of KEYTRUDA in combination with lenvatinib for the first-line treatment of adult patients with advanced clear-cell renal cell carcinoma only.
Unfavourable opinion for reimbursement of KEYTRUDA in combination with lenvatinib in the other situations covered by the MA indication.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of KEYTRUDA 25 mg/ml (pembrolizumab) in combination with lenvatinib is substantialin the first-line treatment of advanced renal cell carcinoma, only in clear-cell RCC or with a clear-cell component;
Insufficient
The Committee deems that the clinical benefit of KEYTRUDA 25 mg/ml (pembrolizumab) in combination with lenvatinib is insufficient to justify public funding in the first-line treatment of advanced renal cell carcinoma with a histological type other than clear-cell given the absence of robust data.
Clinical Added Value
moderate
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.
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