Merck KGaA and Pfizer’s PD-L1 inhibitor Bavencio could be on the EU market from next month, after getting EMA approval as a treatment for the rare skin cancer Merkel cell carcinoma.
Bavencio (avelumab) is the first checkpoint inhibitor to be approved in Europe for Merkel cell carcinoma but has already been approved for this indication by the FDA, which also cleared it for metastatic urothelial carcinoma (mUC), a form of bladder cancer in May.
It was backed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in July as a treatment for adults whose cancer had already spread (metastasised) to other parts of the body.
The new product will be launched first in the UK and Germany, according to Merck, which developed the drug and whose Merck Serono unit will commercialise it in partnership with Pfizer under a $2.85bn oncology alliance between companies dating back to 2014.
Analysts have previously predicted avelumab could have sales of around $600m by 2020 – rising to $4bn-plus at peak – despite jostling with rival checkpoint inhibitors for market share in some indications. It is the fourth drug in the PD-1/PD-L1 inhibitor class to be approved in the EU, after Bristol-Myers Squibb’s Opdivo (nivolumab), Merck & Co’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab), and ahead of AstraZeneca’s Imfinzi (durvalumab).
Approval in Merkel cell carcinoma gives Merck and Pfizer a clear run initially as none of the other checkpoint inhibitors are approved for this indication, although the target population is small at around 2,500 patients per year and of these around 5%-12% have metastatic disease. Once the cancer has spread, fewer than half of patients survive more than one year and less than 20% are still alive five years after diagnosis.
“Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease,” said Dirk Schadendorf, director of dermatology at University Hospital Essen in Germany.
“This approval is a meaningful development for patients and their families suffering from this devastating disease.”
The drug has been given approval based on response rates from the single-arm JAVELIN Merkel 200 trial in patients who had failed to respond to prior chemotherapy for MCC. Around 33% of patients experienced tumour shrinkage while on avelumab therapy, with 9% of patients seeing a complete response to the treatment.
For Merck the drug is part of a series of new products it hopes will generate €2bn or more in revenues by 2022, and is its first major product launch since it introduced colorectal and head and neck cancer therapy Erbitux (cetuximab) more than a decade ago.