Merck Reports Topline Data for Bintrafusp Alfa as Second-Line Monotherapy Treatment in Biliary Tract Cancer

Darmstadt, Germany (ots/PRNewswire) - Not intended for US-, Canada- or UK-based
media

Merck, a leading science and technology company, today announced topline data
from the Phase II INTR@PID BTC 047 study evaluating bintrafusp alfa as a
monotherapy in the second-line treatment of patients with locally advanced or
metastatic biliary tract cancer (BTC) who have failed or are intolerant of
first-line platinum-based chemotherapy.

In the study of 159 patients, bintrafusp alfa demonstrated single-agent efficacy
and durability with a manageable safety profile after more than nine months of
follow-up, with an Independent Review Committee (IRC)-adjudicated objective
response rate (ORR) of 10.1% (95% CI: 5.9% to 15.8%) per RECIST 1.1. Though
single-agent activity was observed, the study did not meet the pre-defined
threshold that would have enabled regulatory filing for BTC in the second line
setting. The results will be submitted for presentation at an upcoming medical
meeting or publication.

"Given the high unmet treatment need in BTC, where single agent immunotherapy in
PD-L1 all comers has shown an ORR of 5.8%, we are encouraged by the single agent
clinical activity of bintrafusp alfa in this study as a second-line treatment,"
said Milind Javle, MD, professor of GI medical oncology, MD Anderson Cancer
Center, and an investigator for the INTR@PID BTC 047 study. "The bintrafusp alfa
047 study is one of the most important clinical investigations conducted for
chemo-refractory biliary cancers, and I would like to thank the patients,
families, and study team for their valuable participation."

"This study demonstrates single-agent activity with bintrafusp alfa in locally
advanced or metastatic BTC, a disease that has been historically difficult to
treat," said Danny Bar-Zohar, M.D., Global Head of Development for the
Healthcare business sector of Merck. "The data will contribute to our
understanding of addressing both TGF-? and PD-L1 inhibition in the tumor
microenvironment."

A Phase II/III study of bintrafusp alfa in combination with chemotherapy as a
first-line treatment for BTC (INTR@PID BTC 055), which is assessing a different
hypothesis than the second-line monotherapy study, has completed enrollment in
the Phase II portion and is currently ongoing.

*Bintrafusp alfa is currently under clinical investigation and not approved for
any use anywhere in the world.

About Biliary Tract Cancer (BTC)

BTCs are a group of rare, aggressive gastrointestinal cancers associated with
poor outcomes and limited treatment options. There is currently no globally