The Committee deems that the clinical benefit of BAVENCIO 20 mg/mL (avelumab) concentrate for solution for infusion remains substantial in the treatment as monotherapy of adult patients with metastatic Merkel cell carcinoma (MCC) previously treated with chemotherapy.
Clinical Added Value
minor
Considering:
the medical need inadequately met by chemotherapies due to their poor safety in elderly patients with comorbidities, or in the event of current contraindication to chemotherapy,
the updated results of the JAVELIN study, showing a relative stability in survival at between 24 and 60 months, with an overall survival at 60 months of 26%,
descriptive results for overall survival at 24 months in the post-registration study consistent with those observed in the JAVELIN study but which do not enable quantification of the potential therapeutic benefit of avelumab compared to initial management before the introduction of avelumab,
the safety of avelumab deemed to be acceptable in this elderly population,
international guidelines positioning immunotherapies, including avelumab, as a first-line treatment for metastatic Merkel cell carcinoma (MCC),
And despite:
the methodological limits of the follow-up data in the JAVELIN study, which is a non-comparative study, and the retrospective and observational data from the CARADERM database,
the Committee deems thatBAVENCIO 20 mg/mL (avelumab)concentrate for solution for infusion provides a minor clinical added value (CAV IV) in the current care pathway (see chapter 2.2).
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