European Commission approves Bavencio® (avelumab) for the treatment of metastatic Merkel cell carcinoma
Summary
●The first immunotherapy approved by the EU for the treatment of rare aggressive skin cancer, and is initially planned to be launched in Germany and the UK
●This approval is based on the previous accelerated approval of BAVENCIO® in the United States and the latest approval by Swissmedic
●This approval was based on data on sustained tumor response rate and response duration included in the Javelin Merkel 200 study.
Darmstadt, Germany and New York, USA - Merck Group China and Pfizer (NYSE: PFE) announced on September 21, 2017 that the European Commission (EC) has approved BAVENCIO® (avelumab) for the monotherapy treatment of adult patients with metastatic Merkel cell carcinoma (mMCC),1 which is a rare and aggressive skin cancer. BAVENCIO® will receive marketing authorization in 28 countries of the European Union (EU), as well as Norway, Liechtenstein and Iceland. European patients can expect to have BAVENCIO® available by prescription within a few months, with Germany and the UK expected to launch the drug first in October 2017.
Dr. Luciano Rossetti, global head of R&D and executive vice president of Merck Group China’s biopharmaceutical business, said:
"The European Commission's decision is significant for BAVENCIO®, and even more important for European patients suffering from this very challenging skin cancer. We will continue to demonstrate the power of collaboration through our alliance with Pfizer, and we are grateful to all those working to bring immunotherapy for metastatic Merkel cell carcinoma, the first and only approved immunotherapy, to patients in Europe."
Liz Barrett, global president of Pfizer's Oncology Division, said: "BAVENCIO® received accelerated approval in the United States earlier this year, and this EU approval further continues our momentum. Importantly, we are one step closer to our goal of helping patients around the world obtain BAVENCIO®."
About 2,500 people in Europe suffer from Merkel cell carcinoma every year, and 5-12% of Merkel cell carcinoma patients have metastases when diagnosed. Less than 20% of patients with metastatic Merkel cell carcinoma survive for more than 5 years. 2-6
Dr. Dirk Schadendorf, Director of the Department of Dermatology at the University Hospital Essen in Germany, said: "Merkel cell carcinoma is a highly aggressive skin cancer with a poor prognosis, especially for patients who have metastasized. This approval is of great significance to patients and their families who have been struck by this disease."
The European Commission's approval is based on data from a study called JAVELIN Merkel 200, which is a multinational, multi-center, single-arm, open-label, phase 2 study that consists of two parts: 1
●The first part enrolled 88 patients with metastatic Merkel cell carcinoma whose disease had progressed after at least one dose of chemotherapy. The objective response rate was 33%, with 11% of patients experiencing complete response and 22% experiencing partial response. Tumor responses were ongoing at the time of analysis, with 93% of responses lasting at least 6 months (n=25) and 71% of responses lasting at least 12 months (n=13). Duration of response (DOR) ranged from 2.8 to 24.9 months.
●At the time of data collection cutoff, Part II enrolled 39 treatment-naïve patients without systemic therapy for metastatic disease who had histologically confirmed metastatic Merkel cell carcinoma. The objective response rate was 62%, with 14% of patients achieving complete response (CR) and 48% achieving partial response (PR). Sixty-seven percent of patients had progression-free survival (PFS) of more than 3 months.
In clinical studies, 1,738 patients with solid tumors, including 88 patients with metastatic Merkel cell tumor, received avelumab at a dose of 10 mg/kg every two weeks to evaluate the safety of the drug: 1
●1738 patients with solid tumors were treated at a dose of 10 mg/kg every two weeks. Among patients, the most common adverse reactions were fatigue (32.4%), nausea (25.1%), diarrhea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight loss (16.6%), and vomiting (16.2%). The most common adverse reactions of grade 3 and above were anemia (6.0%), dyspnea (3.9%), and abdominal pain (3.0%). Serious adverse reactions include immune-related adverse reactions and infusion-related reactions.
The European Commission's decision builds on the U.S. Food and Drug Administration's (FDA) accelerated approval* earlier this year of BAVENCIO® for the treatment of metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after platinum-containing chemotherapy. BAVENCIO® was also approved for marketing by the Swiss Medicines Agency on September 5, 2017, to provide treatment for patients with metastatic Merkel cell carcinoma whose disease has progressed after at least one chemotherapy.
BAVENCIO®'s clinical development program, known as JAVELIN, involves at least 30 clinical programs and is evaluating more than 15 different tumor types in more than 6,300 patients. Cancers other than metastatic Merkel cell carcinoma include breast cancer, gastric/gastroesophageal junction cancer, head and neck cancer, Hodgkin lymphoma, melanoma, mesothelioma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma, and urothelial cancer.
References
BAVENCIO® (avelumab) EU SmPC. Available from: http://www.ema.europa.eu/ema/: Accessed September 2017.
Fitzgerald T et al. Dramatic increase in the incidence and mortality from Merkel cell carcinoma in the United States. Am Surg 2015;81(8):802-6.
Stokes JB et al. Patients with Merkel cell carcinoma tumors < or = 1.0 cm in diameter are unlikely to harbor regional lymph node metastasis. J Clin Oncol 2009;27(23):3772–7.
Allen PJ et al. Merkel cell carcinoma: prognosis and treatment of Patients from a single institution. J Clin Oncol 2005;23(10):2300–9.
IMMOMEC (European Commission). Merkel Cell Carcinoma. Available from: http://www.immomec.eu/project/objectives/background/merkel-cell-carcinoma. Accessed September 2017.
Lemos B et al. Pathologic Nodal Evaluation Improves Prognostic Accuracy in Merkel Cell Carcinoma: Analysis of 5,823 Cases as the Basis of the First Consensus Staging System for this Cancer. Journal of the American Academy of Dermatology. 2010;63:751–761.