Merck Provides Update on Phase III TrilynX Study in Locally Advanced Head and Neck Cancer
25 June 2024 - 6:35AM
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Merck, a leading science and technology company, today announced
the discontinuation of the Phase III randomized TrilynX study
evaluating xevinapant plus chemoradiotherapy (CRT) in patients with
unresected locally advanced squamous cell carcinoma of the head and
neck (LA SCCHN). The decision follows a pre-planned interim
analysis performed by the study’s Independent Data Monitoring
Committee, which found that the trial would be unlikely to meet its
primary objective of prolonging event-free survival. Top-line
safety data were overall compatible with the chemo-radio
sensitizing properties of xevinapant. The company will conduct an
in-depth review of the data and will share the results in a
peer-reviewed forum.
LA SCCHN has proven to be a difficult-to-treat form of cancer.
CRT has remained the standard of care for decades, despite multiple
studies designed to improve outcomes with new treatment approaches,
including multiple immunotherapy trials.
“We sincerely thank the patients, caregivers and clinical
investigators who participated in this trial,” said Danny
Bar-Zohar, Global Head of Research & Development and Chief
Medical Officer for the Healthcare business sector of Merck. “While
we are disappointed by these results, we remain steadfast in our
commitment to develop transformative medicines within our oncology
portfolio for areas of high unmet need.”
Given the totality of the data, the company decided to also stop
the Phase III clinical trial X-Ray Vision (xevinapant plus
radiotherapy, compared to placebo plus radiotherapy) in patients
who underwent resection of locally advanced head and neck
cancer.
Merck is working to develop and deliver new treatment options
that exploit the vulnerabilities of tumor cells. The company is
exploring modalities including antibody-drug conjugates (ADCs) and
DNA damage response (DDR) inhibitors, across multiple tumor types,
including many that have proven difficult to treat where there are
significant unmet needs for patients. The company’s support for the
head and neck cancer community remains steadfast with Erbitux®,
approved in combination with radiotherapy for the initial treatment
of locally advanced SCCHN, and which continues to be studied in
more than 200 active clinical trials, including at least 15 Phase
III studies.
About Xevinapant
Xevinapant (formerly known as Debio 1143) is an investigational
potent oral small-molecule IAP (inhibitor of apoptosis protein)
inhibitor. In March 2021, Merck gained exclusive rights from
Debiopharm International SA to develop and commercialize xevinapant
worldwide. Xevinapant is not approved for any use anywhere in the
world.
Advancing the Future of Cancer Care
At Merck we strive every day to improve the futures of people
living with cancer. Our research explores the full potential of
promising mechanisms in cancer research, focused on synergistic
approaches designed to hit cancer at its core. We are determined to
maximize the impact of our standard-of-care treatments and to
continue pioneering novel medicines. Our vision is to create a
world where more cancer patients will become cancer survivors.
Learn more at www.merckgrouponcology.com.
About Merck
Merck, a leading science and technology company, operates across
life science, healthcare and electronics. Around 63,000 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 providing products and services that accelerate drug
development and manufacturing as well as discovering unique ways to
treat the most challenging diseases to enabling the intelligence of
devices – the company is everywhere. In 2023, Merck generated sales
of € 21 billion in 65 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 MilliporeSigma in life science, EMD
Serono in healthcare, and EMD Electronics in electronics.
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