Pfizer reports positive follow-up data from JAVELIN Merkel 200 trial

6th June 2018 (Last Updated June 6th, 2018 00:00)

Pfizer has reported positive data from the JAVELIN Merkel 200 trial of Bavencio (avelumab) for treatment of patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin cancer.

Pfizer reports positive follow-up data from JAVELIN Merkel 200 trial
Photomicrograph of Merkel cell carcinoma infiltrating the skin (arrow). Credit: Patrick S. Moore.

Pfizer has reported positive data from the JAVELIN Merkel 200 trial of Bavencio (avelumab) for treatment of patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin cancer.

The Phase II, open-label, single-arm JAVELIN Merkel 200 study enrolled patients with histologically confirmed mMCC whose disease had progressed on or after chemotherapy administrated for distant metastatic disease.

During the trial, patients received 10mg/kg of Bavencio intravenously every two weeks until disease progression or unacceptable toxicity. The researchers followed 88 patients for a median of 29.2 months as part of the study.

The new efficacy and safety data are result of a two-year follow-up update of the JAVELIN Merkel 200 trial.

The data demonstrated that Bavencio continues to show clinically meaningful durable responses and stable rates of progression-free survival (PFS) and overall survival (OS) from previous evaluations in patients who responded to this treatment.

"These results represent a key milestone for patients with mMCC, as chemotherapy has historically been the only treatment option for this devastating disease."

Clinical activity was observed across all patient subgroups, while the safety profile of Bavencio was found to be consistent with longer follow-up and with those observed in the overall JAVELIN clinical development programme.

Pfizer Global Product Development Immuno-Oncology, Early Development and Translational Oncology senior vice-president and head Chris Boshoff said: “These results represent a key milestone for patients with mMCC, as chemotherapy has historically been the only treatment option for this devastating disease.

“This data, alongside the additional real-world data which is also being presented at ASCO, strengthen our confidence in Bavencio as a treatment option for this rare and aggressive skin cancer.”

In November 2014, Pfizer signed a strategic alliance with Germany’s Merck to jointly develop and commercialise avelumab, a human anti-programmed death ligand-1 (PD-L1) antibody.