Favorable opinion for reimbursement of KEYTRUDA in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) is substantial in the marketing authorisation indication.
Clinical Added Value
minor
In view of:
the evidence of superiority of pembrolizumab combined with gemcitabine and cisplatin compared to the gemcitabine and cisplatin combination alone, in a randomised, double-blind study, in terms of overall survival (OS, primary outcome measure),
the effect size deemed to be modest but significant, with an absolute difference for median OS of 1.8 months, with a stratified HR= 0.83; 95% CI [0.72; 0.95]),
the lack of evidence of superiority on progression-free survival and on overall response rate,
the lack of formal conclusions that can be drawn from the exploratory secondary outcome measure findings including quality of life,
a safety profile deemed to be acceptable,
the medical need partially met by the available alternatives and the evolution of guidelines for the management of advanced bile duct cancer,
the Transparency Committee deems that KEYTRUDA (pembrolizumab) 25 mg/ml, solution for dilution for infusion, like IMFINZI (durvalumab), provides minor clinical added value (CAV IV) compared to gemcitabine + cisplatin chemotherapy in the first-line treatment of adults with unresectable or metastatic biliary tract carcinoma (BTC).
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