The recent first global approval of avelumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.
In March 2017, avelumab (Bavencio®), developed by Merck and Pfizer, received its first global approval in the US for the treatment of patients older than 12 years with metastatic Merkel cell carcinoma (MCC). Avelumab is an intravenously administered human IgG1 lambda monoclonal antibody that blocks the programmed cell death ligand-1 (PD-L1). PD-L1 is expressed in MCC cells and binds to the PD receptor 1 found on cytotoxic T cells and prevents their tumour-killing activity; blocking this interaction restores the anti-tumour immune responses. This biologic is also under regulatory review for metastatic MCC in the EU.
MCC is a rare cancer with an estimated incidence of 0.24 per 100,000 people, and while it is about 40 times less common than melanoma, it is three times more lethal (one in three compared with one in nine patients die from the disease).1
Avelumab is the first immunotherapy to be approved for use in metastatic MCC, a disease that historically has not responded well to available chemotherapy.
“At the heart of this FDA approval is our drive to make a meaningful difference for patients with hard-to-treat cancers like metastatic Merkel cell carcinoma,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck. He went on to acknowledge the global involvement and particularly the alliance with Pfizer.2
Albert Bourla, Group President, Pfizer Innovative Health, also remarked on “the power of collaboration”, and stated that the approval of avelumab was “… a significant milestone for people fighting metastatic Merkel cell carcinoma, who until now have not had any options beyond chemotherapy.”2
Deborah S. Sarnoff, MD, President of the Skin Cancer Foundation, echoed these sentiments in her comment that “With this approval, I believe there is new hope for people and their families touched by this rare form of skin cancer.”2
Avelumab was granted breakthrough therapy designation and oprhan drug status for MCC, and the Biologics License Application (BLA) was given priority review. Consequent to this accelerated approval, the FDA requires an additional clinical trial to be completed to confirm clinical benefit.3
Avelumab, is also under phase II investigation in Australia, Switzerland and Japan for metastatic MCC, and in February 2017 the FDA accepted for priority review the BLA for avelumab in metastatic urothelial carcinoma.
Globally avelumab is under various phases of clinical investigation for a variety of solid tumours and haematological cancers.
Throughout 2016, Merck and Pfizer initiated collaborations with multiple partners to investigate the use of avelumab in combination with several different agents for the treatment of various cancers.
Merck and Pfizer have collaborated with Dako (an Agilent Technologies company) to develop a companion diagnostic test for use with avelumab that will measure the levels of PD-L1 protein expression in tumour tissue.4