Merck KGaA Release: EMA's CHMP Issues Positive Opinion For Avelumab For The Treatment Of Metastatic Merkel Cell Carcinoma

Published: Jul 21, 2017

DARMSTADT, Germany and NEW YORK, July 20, 2017 /PRNewswire/ --

Not intended for UK-based media   

  • If approved, avelumab could be the first immunotherapy treatment indicated for this rare and aggressive skin cancer in the EU   
  • Decision by the EC is expected in the third quarter of 2017

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab* (BAVENCIO®) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. The European Commission (EC) will now review the CHMP's recommendation, with a decision expected in the third quarter of 2017.

"We welcome the CHMP's recommendation, as there are currently no approved treatments in Europe for this type of skin cancer, which can be devastating for patients and their families," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany. "This is an important step towards making avelumab available to patients and we look forward to the European Commission's decision later this year."

"Metastatic Merkel cell carcinoma is a devastating disease and patients in Europe currently have very few treatment options," said Chris Boshoff, M.D., PhD, Senior Vice President and Head of Immuno-Oncology, Early Development, Translational Oncology, Pfizer Global Product Development. "This milestone further demonstrates our commitment to tackle hard-to-treat cancers as we continue to explore the potential of avelumab in other tumors."

The CHMP positive opinion is based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study split into two parts:

  • Part A included 88 patients with mMCC whose disease had progressed after at least one chemotherapy treatment, with 59% of patients reported to have had one prior anti-cancer therapy for mMCC and 41% had two or more prior therapies. Data submitted included a minimum of 18 months of follow-up.
  • Part B, at the time of the data cut-off, included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in metastatic setting, 29 of whom had at least 13 weeks of follow-up. Enrolment in Part B of the study is ongoing and is planned to include 112 treatment-naïve patients.

The human anti-PD-L1 antibody, avelumab, previously received Orphan Drug Designation (ODD) from the EC for MCC. To qualify for ODD in the EU, a medicine must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating, and has a prevalence in the EU of not more than 5 in 10,000 people.

The US Food and Drug Administration (FDA) granted accelerated approval for avelumab in March 2017 for the treatment of mMCC in adults and pediatric patients 12 years and older; and in May 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.[1] These indications were granted under accelerated approval based on tumor response rate and duration of response data/criteria. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and more than 6,000 patients evaluated across more than 15 different tumor types. In addition to mMCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial carcinoma.

*Avelumab is not approved for any indication in any market outside the US. BAVENCIO® is the proprietary name submitted to EMA for the investigational medicine avelumab.

About Metastatic Merkel Cell Carcinoma    

Metastatic MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings.[2],[3] MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, and arms.[2],[4] Risk factors for MCC include sun exposure and infection with Merkel cell polyomavirus. Caucasian males older than 50 are at increased risk.[2],[4] MCC is a highly immunogenic cancer, meaning that those with a weak immune system (i.e., solid organ transplant recipients, people with HIV/AIDS and people with other cancers, such as chronic lymphocytic leukemia) are also at a higher risk.[2],[4] MCC is often misdiagnosed for other skin cancers and grows at an exponential rate on chronically sun-damaged skin.[4]-[6] Current treatment options for MCC in Europe include surgery, radiation and chemotherapy.[3] Treatment for metastatic or Stage IV MCC is generally palliative.[3]

About JAVELIN Merkel 200   

The efficacy and safety of avelumab was demonstrated in the JAVELIN Merkel 200 trial, an international, multicenter, single-arm, open-label, Phase II study split into two parts:

  • Part A was conducted in 88 patients with histologically confirmed mMCC whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with life expectancy of more than 3 months. Overall, in Part A, 59% of patients were reported to have had one prior anti-cancer therapy for mMCC and 41% had two or more prior therapies. Data submitted included a minimum of 18 months follow-up. The major efficacy outcome measures for Part A were confirmed best overall response (BOR) and duration of response (DOR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by a blinded independent endpoint review committee (IERC); secondary efficacy outcome measures included duration of response (DOR), and progression-free survival (PFS).
  • Part B, at the time of the data cut-off, included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting, 29 of whom had at least 13 weeks of follow-up. Enrolment in Part B of the study is ongoing and is planned to include 112 treatment-naïve patients. The major efficacy outcome measure is durable response, defined as objective response (complete response [CR] or partial response [PR]) with a duration of at least 6 months; secondary outcome measures include BOR, DOR, progression-free survival (PFS) and overall survival (OS).

The trial excluded patients with active or a history of central nervous system (CNS) metastasis, active or a history of autoimmune disease, a history of other malignancies within the last 5 years, organ transplant, and conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C. Patients received avelumab 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.



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