PR88513

DARMSTADT, Germany, March 16, 2021 /PRNewswire=KYODO JBN/ --

- 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-Beta 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

accepted standard of care in the second-line setting and chemotherapy as well

as immunotherapies have demonstrated low response rates in BTC.

Epithelial-to-mesenchymal transition (EMT), a hallmark of tumor progression and

drug resistance, plays an important role in BTC, and has been shown to be

triggered by TGF-Beta signaling.

About Bintrafusp Alfa

Bintrafusp alfa (M7824), discovered in-house at Merck, and currently in

clinical development through a strategic alliance with GSK, is a potential

first-in-class investigational bifunctional fusion protein designed to

simultaneously block two immunosuppressive pathways, TGF-Beta and PD-L1, within

the tumor microenvironment. This bifunctional approach is thought to control

tumor growth by potentially restoring and enhancing anti-tumor responses. In

preclinical studies, bintrafusp alfa has demonstrated antitumor activity both

as monotherapy and in combination with chemotherapy. Based on its mechanism of

action, bintrafusp alfa offers a potential targeted approach to addressing the

underlying pathophysiology of difficult-to-treat cancers.

About the INTR@PID Clinical Trial Program

INTR@PID is a global clinical trial program investigating the potential

co-localized, dual inhibition of TGF-Beta and PD-L1 with bintrafusp alfa

(M7824) in multiple tumor types. Current clinical trial information can be

found on the INTR@PID website at www.intrapidclinicaltrials.com. To date,

globally more than 1,300 patients with various types of solid tumors have

received bintrafusp alfa in the INTR@PID clinical development program.

The INTR@PID clinical development strategy is comprehensive and is pursuing

non-redundant hypotheses grounded in preclinical and early clinical data

findings that continue to be explored and may yield clinically meaningful

insights to patients in need, including exploring settings where simultaneous,

synchronized targeting of TGF-Beta and PD-L1 may offer the key to expanding the

potential of immunotherapy; focusing on opportunities where PD-1/PD-L1 has

suboptimal clinical activities and pathogenesis linked to TGF-Beta biology; and

targeting specific tumors with biomarkers with a strong link to TGF-Beta

signaling pathway.

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About Merck

Merck, a leading science and technology company, operates across healthcare,

life science and electronics. Around 58,000 employees work to make a positive

difference to millions of people's lives every day by creating more joyful and

sustainable ways to live. From advancing gene editing technologies and

discovering unique ways to treat the most challenging diseases to enabling the

intelligence of devices - the company is everywhere. In 2020, Merck generated

sales of EUR17.5 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to

Merck's technological and scientific advances. This is how Merck has thrived

since its founding in 1668. The founding family remains the majority owner of

the publicly listed company. Merck holds the global rights to the Merck name

and brand. The only exceptions are the United States and Canada, where the

business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma

in life science, and EMD Electronics.

Your Contacts

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SOURCE  Merck