Merck Advances Oncology Portfolio and Pipeline with New and Long-term Data in Multiple Cancers at ESMO 2020 - Seite 4

also indicated for the treatment of patients with locally advanced or metastatic
urothelial carcinoma who have disease progression during or following
platinum-containing chemotherapy, or have disease progression within 12 months
of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line
treatment of patients with advanced renal cell carcinoma (RCC). Additionally,
the US Food and Drug Administration (FDA) granted accelerated approval for
avelumab (BAVENCIO®) for the treatment of adults and pediatric patients 12 years
and older with metastatic Merkel cell carcinoma (MCC). This indication is
approved under accelerated approval based on tumor response rate and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally,
with the majority of these approvals in a broad indication that is not limited
to a specific line of treatment.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for BAVENCIO monotherapy include
infusion-related reactions, as well as immune-related adverse reactions that
include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis
(including fatal cases), myocarditis (including fatal cases), endocrinopathies,
nephritis and renal dysfunction, and other immune-related adverse reactions. The
special warnings and precautions for use for BAVENCIO in combination with
axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in
patients with solid tumors includes fatigue, nausea, diarrhea, decreased
appetite, constipation, infusion-related reactions, weight decreased and
vomiting. The list of most common adverse reactions with BAVENCIO in combination
with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia,
decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

About Tepotinib

Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET
receptor signaling caused by MET (gene) alterations. Discovered and developed
in-house at Merck, it has been designed to have a highly selective mechanism of
action, with the potential to improve outcomes in aggressive tumors that have a
poor prognosis and harbor these specific alterations. In March 2020, tepotinib
became the first oral MET inhibitor indicated for the treatment of advanced