Merck and Pfizer have launched in the UK of Bavencio, the first medicine to be licensed for the treatment of the rare, aggressive skin cancer of metastatic Merkel Cell Carcinoma (mMCC).
The companies note that the availability of Bavencio (avelumab) marks a step-change in the way that the disease is treated given that, until now, the only treatment option for patients has been chemotherapy.
“The licensing of avelumuab in this disease is an advance for patients as it is well tolerated, and active,” noted Professor Ruth Plummer, consultant medical oncologist at the Newcastle upon Tyne Hospitals NHS Foundation Trust. “Patients with mMCC are often elderly and find our standard chemotherapy hard going, needing dose reductions or breaks from treatment.”
Bavencio, a fully human anti-PD-L1 IgG1 monoclonal antibody, was approved in Europe in September on the back of data from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase II study of 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment.
The data, published in the Lancet Oncology, showed durable responses to drug; the proportion of patients who achieved an objective response was 28 (31.8 percent) of 88 patients, including eight complete responses and 20 partial responses.
It is thought that there are around 50 new cases of mMCC annually in the UK, but data show that the incidence rising, possibly because of an ageing population or increased UV exposure, the firms note.
“We’re really encouraged by the news that avelumab is now licensed for use in the UK,” commented Catherine Bouvier, chief executive of the NET Patient Foundation.
“Although rare, mMCC is an aggressive cancer with potentially worse outcomes than other types of skin cancer such as melanoma. An effective, well-tolerated treatment option will be welcomed with open arms by patients with mMCC and their families, so we hope that all stakeholders will work in a collaborative way to ensure that patients in the UK now have access to it as quickly as possible.”
NICE has already kicked off a technology appraisal to determine whether the treatment is cost effective enough for NHS use, with final guidance expected by April next year.