Pivotal avelumab data in Merkel cell carcinoma presented at ASCO
pharmafile | June 6, 2016 | News story | Manufacturing and Production, Research and Development | ASCO, Merck, Pfizer, avelumab, merkel cell carcinoma
New data presented at the American Society of Clinical Oncology’s annual general meeting has shown that avelumab, an investigational anti-PD-L1 antibody co-developed by Merck (KGaA, Darmstadt, Germany) and Pfizer (NYSE: PFE), demonstrates clinically meaningful tumour responses in pre-treated metastatic Merkel cell carcinoma.
The Phase II study results in the rare, and highly aggressive, form of skin cancer with 88 patients represents the largest data set of any anti-PD-L1/PD-L1 reported in this patient population. The disease has a poor prognosis, with less than 20% of patients surviving longer than five years. Chemotherapy is usually employed as a second line of treatment and is not considered a standard of care.
In the study, avelumab showed a 31.8% objective response rate in the pre-planned primary analysis of the study. 78.6% of these patients experienced rapid tumour responses, within seven weeks of starting treatment. 82.1% of patients were still responding at the time of the pre-planned analysis.
Other important takeaways from the data include: 40% rate of progression-free survival at six months and an overall survival rate at six months of 69%.
Lead study investigator, Dr Howard L. Kauffman, says: “To see a tumour response in almost a third of patients in this trial, and for the majority to keep responding after six months, represents a potential breakthrough for this challenging disease.”
Luciano Rossetti, executive VP of global R&D at Merck, comments: “The clinically meaningful tumour response rate for avelumab in metastatic Merkel cell carcinoma where chemotherapy has failed, reinforces our belief in the promise of this molecule, particularly considering the high unmet need in this disease.”
The drug has been granted priority review by the FDA and the EMA, including orphan drug designation in both, and fast track and breakthrough status in the US. It is expected that these data will form the basis of marketing authorisation applications to the relevant authorities.
Sean Murray
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