Favourable opinion on reimbursement solely in patients with recurrent or metastatic cervical cancer and with disease progression during or after platinum-based chemotherapy without the addition of pembrolizumab.
What therapeutic improvement?
LIBTAYO (cemiplimab), in monotherapy, is a second-line treatment for recurrent or metastatic cervical cancer with disease progression during or after platinum-based chemotherapy without the addition of pembrolizumab.
Clinical Benefit
Substantial
The clinical benefit provided by LIBTAYO 350 mg (cemiplimab), concentrate for solution for infusion is significant solely in patients with recurrent or metastatic cervical cancer with disease progression during or after platinum-based chemotherapy without the addition of pembrolizumab.
Insufficient
In the remainder of the indication, the Committee considers that the clinical benefit provided is insufficient.
Clinical Added Value
moderate
In view of:
the demonstration in a phase III, comparative, randomised open study of the superiority of cemiplimab compared to chemotherapy left to the choice of the investigator, in the treatment of recurrent, persistent or metastatic cervical cancer, that has progressed or recurred after treatment with platinum salts ± bevacizumab, in terms of overall survival (OS) with a median difference of 3.5 months and an HR = 0.685, 95% CI = [0.560; 0.838] in the overall study population;
the profile of patients in the EMPOWER 1676 study who were not exposed to pembrolizumab, even though this immunotherapy has recently been incorporated into the first-line therapeutic strategy for eligible patients;
the acceptable tolerance profile.
the Committee considers that LIBTAYO (cemiplimab) provides moderate clinical added value (CAV III) compared to monochemotherapies (pemetrexed, gemcitabine, irinotecan, topotecan and vinorelbine) solely in patients with recurrent or metastatic cervical cancer with disease progression during or after platinum-based chemotherapy without the addition of pembrolizumab.
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