EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma

Darmstadt, Germany and New York (ots/PRNewswire) -

Not intended for US, Canadian and UK-based media

- If approved, avelumab could be the first immunotherapy treatment
indicated for this rare and aggressive skin cancer in the EU
- Decision by the EC is expected in the third quarter of 2017

Merck and Pfizer Inc. (NYSE: PFE) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has recommended the approval of avelumab*
(BAVENCIO®) as a monotherapy for the treatment of adult patients with
metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin
cancer. The European Commission (EC) will now review the CHMP's
recommendation, with a decision expected in the third quarter of
2017.

"We welcome the CHMP's recommendation, as there are currently no
approved treatments in Europe for this type of skin cancer, which can
be devastating for patients and their families," said Luciano
Rossetti, M.D., Executive Vice President, Global Head of Research &
Development at the biopharma business of Merck. "This is an important
step towards making avelumab available to patients and we look
forward to the European Commission's decision later this year."

"Metastatic Merkel cell carcinoma is a devastating disease and
patients in Europe currently have very few treatment options," said
Chris Boshoff, M.D., PhD, Senior Vice President and Head of
Immuno-Oncology, Early Development, Translational Oncology, Pfizer
Global Product Development. "This milestone further demonstrates our
commitment to tackle hard-to-treat cancers as we continue to explore
the potential of avelumab in other tumors."

The CHMP positive opinion is based on data from JAVELIN Merkel
200, an international, multicenter, single-arm, open-label, Phase II
study split into two parts:

- Part A included 88 patients with mMCC whose disease had progressed
after at least one chemotherapy treatment, with 59% of patients
reported to have had one prior anti-cancer therapy for mMCC and 41%
had two or more prior therapies. Data submitted included a minimum
of 18 months of follow-up.
- Part B, at the time of the data cut-off, included 39 patients with
histologically confirmed mMCC who were treatment-naïve to systemic
therapy in the metastatic setting, 29 of whom had at least 13 weeks
of follow-up. Enrolment in Part B of the study is ongoing and is
planned to include 112 treatment-naïve patients.

The human anti-PD-L1 antibody, avelumab, previously received
Orphan Drug Designation (ODD) from the EC for MCC. To qualify for ODD