CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

Not intended for US, Canada and UK-based media

- Opinion based on Phase III data showing combination lowered risk of
disease progression or death by 31% and improved objective response
rate compared with sunitinib1
- Decision by the European Commission anticipated in fourth quarter
of 2019

Darmstadt, Germany and New York, Us (ots/PRNewswire) - Merck and
Pfizer Inc. (NYSE: PFE) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted a positive opinion recommending approval of
BAVENCIO® (avelumab) in combination with axitinib for the first-line
treatment of adult patients with advanced renal cell carcinoma (RCC).
The opinion was based on positive findings from the Phase III JAVELIN
Renal 101 study, which demonstrated a significant extension in median
progression-free survival (PFS) and a clinically meaningful
improvement in objective response rate (ORR) for the combination
across all prognostic risk groups compared with sunitinib.1 The CHMP
positive opinion will be reviewed by the European Commission (EC),
with a decision anticipated in the fourth quarter of this year. Merck
and Pfizer have a global strategic alliance to jointly develop and
commercialize BAVENCIO.

"Today's positive CHMP opinion is a significant step toward
potentially transforming the treatment landscape and bringing much
needed options to people living with advanced renal cell carcinoma in
Europe. We believe that the combination of BAVENCIO plus axitinib has
the potential to help address a significant need for patients with
advanced renal cell carcinoma for first-line treatments with a
benefit across all prognostic risk groups, and we look forward to a
decision from the European Commission," said Luciano Rossetti, M.D.,
Executive Vice President, Head of Global Research & Development at
the Biopharma business of Merck.

In 2018, an estimated 136,500 new cases of kidney cancer were
diagnosed in Europe, and approximately 54,700 people died from the
disease.2 RCC is the most common form of kidney cancer, accounting
for about 3% of all cancers in adults.2 Approximately 20% to 30% of
patients are first diagnosed with RCC at the advanced stage, and 30%
of patients treated for an earlier stage go on to develop
metastases.3,4 About half of patients living with advanced RCC do not
go on to receive additional treatment after first-line therapy,5,6
for reasons that may include poor performance status or adverse
events from their initial treatment.5,7,8 The five-year survival rate
for patients with metastatic RCC is approximately 12%.9