Bavencio becomes first treatment for rare skin cancer mMCC licensed for use in the UK

The launch of avelumab marks a step-change in the way that mMCC can be treated.

Merck and Pfizer have announced the UK launch of Bavenio (avelumab) solution for infusion 20 mg/mL, as a monotherapy for the treatment of mMCC in adults. Avelumab is the first medicine to be licensed for this rare, aggressive type of skin cancer.

Bavencio becomes first treatment for rare skin cancer mMCC licensed for use in the UK

“The licensing of avelumuab in this disease is an advance for patients as it is well tolerated, and active,” commented 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.”

The incidence of mMCC is so low that it is hard to be accurate; it is thought, however, that there are approximately 50 new cases of mMCC annually in the UK. However, data show that the incidence of MCC is rising possibly due to an ageing population or increased UV exposure. MCC exhibits aggressive clinical features, including frequent lymph node involvement and early metastases. Patients with mMCC have a very poor prognosis, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond 5 years.

While earlier-stage MCC can be generally managed with surgery and radiotherapy, treatment options for mMCC are severely limited. Until now, there have been no licensed medicines to treat mMCC in the UK. As such, the standard of care for patients with mMCC is to enrol in clinical trials.

The efficacy and safety of avelumab was demonstrated in the JAVELIN Merkel 200 trial, an international, multicentre, single-arm, open-label, Phase II study with two parts (still ongoing):

  • Part A15,16 included 88 patients with mMCC whose disease had progressed after at least one chemotherapy treatment. The objective response rate was 33%, with 11% of patients experiencing a complete response and 22% of patients experiencing a partial response. Responses were noted at the time of the first post-baseline tumour assessment (week 7) in 22 (76%) of 29 patients. At the time of analysis, tumour responses were durable, with 93% of responses lasting at least 6 months and 71% of responses lasting at least 12 months. The overall survival rate at 6 months was 69%.
  • Part B (still enrolling), at the time of the data cut-off (March 2017), included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting. The objective response rate was 62%, with 14% of patients experiencing a complete response (CR) and 48% of patients experiencing a partial response (PR). 16 of 18 confirmed responses (88.9%) occurred approximately 6 weeks after treatment initiation.
  • Avelumab was well tolerated in line with the overall safety database. Most AEs related to treatment were low grade, including all infusion reactions.
  • “We’re really encouraged by the news that avelumab is now licensed for use in the UK,” commented Catherine Bouvier, CEO 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.”

    “Today is a significant milestone for the Alliance between Merck and Pfizer,” commented Dr Belinda Byrne, Medical Director at Merck, UK. “It demonstrates our commitment to working in partnership to develop new treatment options for patients with hard-to-treat cancers and we are looking forward to exploring future potential monotherapy indications and a diverse range of novel combinations with avelumab.”

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