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Health awareness

Acting early in cancer detection

Diagnosing cancer early, before it has spread, may potentially lead to better outcomes

October 12, 2023

Three senior-age men talking and laughing

Time is important with a cancer diagnosis. People with cancer may have the opportunity for better outcomes when the disease is detected early. And with increases in routine cancer screening, more cancer cases can be diagnosed before the disease has spread to other parts of the body.

“We’ve seen incredible progress in the fight against cancer in recent decades, driven by advances in early detection and the availability of new treatment options,” said Dr. Scot Ebbinghaus, vice president, oncology clinical research. “This progress makes me optimistic for a future where cancer is detected and treated as early as possible, giving patients the greatest chance to live cancer-free. We can’t rest now — I’m hopeful that we will continue to build on what we’ve learned about helping people with earlier stages of disease.”

But important work remains to continue to improve care and diagnose cancer early.

What is early-stage cancer?

After someone is diagnosed with cancer, doctors will try to figure out how much cancer is in the body and if their disease has spread — this process is called staging, which can help guide treatment decisions. Different cancer stages have different treatments and possible outcomes, and they’re associated with different odds of recurrence.

Early-stage is a term that can be used to describe cancer that’s early in its growth, before it has spread to other parts of the body. However, each person’s experience with cancer is unique, and what doctors may define as early-stage can vary by the type of cancer.

When cancer is diagnosed, the goals of treatments are to slow, stop and possibly eliminate tumor growth.

Treatment may be more likely to be successful if it’s started before the cancer has spread, when surgery is a potential option. However, even after surgery, there is a risk that the cancer may spread to other parts of the body. Additional treatment may help lower that risk. In certain instances, other treatment options can be used before surgery (neoadjuvant) to help to reduce the size of the tumor, and/or after surgery (adjuvant) to lower the chance of the cancer from potentially coming back.

Detecting and treating cancer early may help reduce the risk of recurrence and increase the potential for survival.

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Health awareness

A physician committed to advancing pneumococcal disease research

Dr. Kristen Feemster and her team work to help address pneumococcal disease for people of all ages

October 11, 2023

Before becoming an executive director of global medical affairs at Merck, Dr. Kristen Feemster practiced as a pediatric infectious disease physician. Early in her career, Feemster and her team cared for a 1-year-old patient suffering from pneumococcal meningitis. Sadly, the child succumbed to his illness. Feemster recalls the emotions she felt knowing her own son of about the same age could also be at risk.

“I could barely stay in the room to talk to the child’s parents. As a parent myself, seeing them go through such a devastating loss led me to ask why this happened and what could have prevented the outcome,” said Feemster.

“I was determined to do what I could to help protect people of all ages from pneumococcal disease and its impact.”

At Merck, Feemster and her team work to better understand and communicate the continued epidemiologic impact of pneumococcal disease across all stages of life.

“Knowing that pneumococcal disease remains a leading cause of illness and death globally, I’m inspired by the opportunity to help address challenging and emerging diseases,” she said.

While some factors, like age or underlying medical conditions, can increase the risk of contracting an infection, anyone can get pneumococcal disease.

Noninvasive pneumococcal disease, such as otitis media or pneumonia, are also important contributors to morbidity in children. Recent reports suggest IPD remains a concern and certain serotypes continue to emerge as prevalent causes of serious disease with sometimes life-threatening complications.

Feemster and her Merck colleagues remain committed to addressing pneumococcal disease in people of all ages.

“Too many people worldwide don’t have access to effective treatment and supportive care,” she said. “It’s important that we continue to improve surveillance capabilities and explore this bacterium with such a complex epidemiology. We’ve learned a great deal, but there’s so much left to understand and more that we can do.”

Invasive pneumococcal disease can lead to a number of serious illnesses in children

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Innovation

Uniting research and manufacturing to help patients faster

The opening of our updated site in Ireland will increase collaboration and speed to market

October 5, 2023

Great science requires collaboration. At Merck, scientists and engineers from across the company work together to achieve our purpose of using the power of leading-edge science to save and improve lives.

And at our new state-of-the-art site in Dunboyne, Ireland, we’re bringing together our research and manufacturing teams for the first time to support stronger collaboration during the development and manufacturing of clinical supplies.

“At Dunboyne, we’ll see the power of teamwork between the teams, creating a model that becomes our new way of working,” said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division. “This site offers the chance to harness the expertise of our exceptional manufacturing and research teams.”

Representatives from Merck meet with Leo Varadkar (center), the country’s prime minister — known as the taoiseach — and other Irish officials to celebrate the milestone.

Two facilities, one team

The two components of our Dunboyne site will play a pivotal role in our biologics pipeline. Combined, they represent our first single-use commercialization facility dedicated to manufacturing key biologics for clinical trials, product registration and launch. At the nearby manufacturing facility, teams design the process engineering necessary to produce biologics at a large scale.

The close collaboration of these teams will significantly increase our speed to market and ultimately quicken our ability to help patients.

"This integrated approach will use state-of-the-art scientific and technological innovations to get our medicines to people around the world who need them the most, faster than ever before.”

— Mike Kress

Senior vice president, chemistry, Merck Research Laboratories

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For more information and resources, visit UncoverTNBC.com.

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Health awareness

Triple-negative breast cancer: risks, signs and symptoms, and diagnosis

Learn about this aggressive type of breast cancer, including risk factors, signs and symptoms

October 3, 2023

Breast cancer is the most common cancer in women in the U.S. outside of skin cancers. It accounts for about 1 in 3 of all new cancers in people assigned female at birth each year, and about 1 in 8 females in the U.S. will develop breast cancer over the course of their lifetime. There are many different types and subtypes of breast cancer that are defined by where in the breast they begin, how much they have grown or spread and how they behave. One of the more aggressive types is triple-negative breast cancer (TNBC).

What’s triple-negative breast cancer?

While some people with breast cancer may test positive for three receptors, or proteins, that make cancer grow (estrogen receptors, progesterone receptors, or overexpression of human epidermal growth factor receptor 2, known as HER2), people with TNBC test negative for all three.

In the U.S. in 2023, an estimated 297,790 patients will be diagnosed with breast cancer

~10-15%

of people with breast cancer will be diagnosed with TNBC

TNBC characteristically has a high recurrence rate within the first five years after diagnosis.

Who’s at risk for triple-negative breast cancer?

Primary risk factors for TNBC include:

Race/ethnicity: Non-Hispanic Black women are nearly two times as likely to have TNBC as non-Hispanic white women.
Age: TNBC is more common in women younger than 40.
Sex: People assigned female at birth are at higher risk for TNBC compared to people assigned male at birth.
Genetic mutations: Mutations in genes such as BRCA1 and BRCA2 are strongly associated with TNBC.

What are the signs and symptoms of breast cancer?

TNBC can have the same signs and symptoms as other common types of breast cancer.

Most breast cancers are detected before any symptoms appear through regular breast cancer screenings. The signs and symptoms of breast cancer differ from person to person, and some will never show symptoms.

However, some signs of breast cancer to watch out for include:

Swelling of all or part of a breast
Skin dimpling
Breast or nipple pain
Nipple retraction
Nipple or breast skin that’s red, dry, flaking or thickened
Nipple discharge
Swollen lymph nodes, under the arm or near the collar bone

How is breast cancer diagnosed?

If you’re experiencing symptoms, speak with your doctor, especially if you have a higher risk of having TNBC. Some screening tests include:

Mammogram: An X-ray of the breast that allows doctors to look for changes in breast tissue. Mammograms can often find breast cancer early when it’s easiest to treat.
Magnetic resonance imaging (MRI): An MRI uses radio waves and strong magnets to make detailed pictures of the inside of the breast. Doctors use MRIs along with mammograms to screen people who are considered at high risk for breast cancer.
Ultrasound: An ultrasound uses sound waves and their echoes to make computer pictures of the inside of the breast. While not typically used as a routine screening test for breast cancer, an ultrasound can be useful for looking at some breast changes such as lumps – especially when they can be felt but not seen on a mammogram.
Biopsy: After a breast cancer diagnosis is made with a biopsy, a health care provider may determine whether a patient has TNBC with an assessment of cells from that biopsy, which are checked for estrogen, progesterone and HER2 receptors, to determine the cancer subtype.

How is triple-negative breast cancer staged?

Doctors use five stages to classify triple-negative breast cancer and inform next steps in your care plan:

Stage 0

Cancers diagnosed at stage 0 are confined to the milk ducts and lobes of the breast. When diagnosed at stage 0, TNBC is considered non-invasive breast cancer, and 91% percent of people diagnosed with localized TNBC are alive five years after diagnosis.

Stage 1

Cancers diagnosed at stage 1 are small, localized and have not spread beyond one nearby lymph node. Stage 1 TNBC is still considered early stage, so 91% percent of people diagnosed with this stage of cancer are alive five years after their diagnosis. Stage 1 cancer can be classified as either stage 1A or stage 1B dependent on the size of the tumor and whether there is evidence of cancer on the nearby lymph nodes.

Stage 2

Stage 2 TNBC may have spread regionally (beyond the initial site), but not beyond the lymph nodes in the underarm area. Stage 2 cancer can be classified as either stage 2A or stage 2B dependent on the size of the tumor and whether the breast cancer has spread to the lymph nodes. For patients whose cancer has spread to regional lymph nodes, 66% percent of people diagnosed are still alive five years after their diagnosis.

Stage 3

Stage 3 TNBC has extended beyond the immediate region of the tumor and may have invaded nearby lymph nodes and muscles but has not spread to distant organs. At this stage, TNBC can be classified as stage 3A, 3B or 3C, depending on the size of the tumor and how far it has spread. Stage 3 TNBC is considered to have spread regionally, so 66% percent are still alive five years after diagnosis.

Stage 4

Stage 4 TNBC, also known as metastatic breast cancer, has spread distantly to other areas or organs of the body, such as the brain, bones, lung or liver. This stage is not curable but is usually treatable, and current advances in research and medical technology mean that more people are living longer by managing the disease as a chronic illness. Twelve percent of patients diagnosed at this stage survive five years post-diagnosis.

Being diagnosed with TNBC can be scary. By speaking with your care team, you can better understand your options and the best path forward.

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Innovation

Macrocyclic peptides: the next wave of drug discovery

Merck scientists say the “Goldilocks” chemical modality could lead to new ways to impact disease

September 14, 2023

Small molecules, generally taken as pills, make up nearly 90% of medicines used today. It’s hard to think of a world without them. The use of small molecules has been critical in expanding the reach of and access to medicines around the world.

But it’s challenging for small molecules to impact the large featureless surfaces of protein-protein interactions, which govern a wide range of biological processes in our bodies. To target these interactions, scientists have turned to large molecule biologic therapies, like monoclonal antibodies, which — taken by infusion or injection — have been critical in advancing the treatment of many diseases, including some cancers and autoimmune disorders.

Over a decade ago, Merck scientists began investigating a way to engineer a new type of medicine combining the ease-of-administration of a small molecule with the potency and target specificity of an antibody.

Macrocyclic peptides have shown promise in achieving this balance.

“Macrocyclic peptides allow us to cast a wider net on the protein interactions we want to drug, providing a vast and untapped opportunity to access a wider range of targets and potentially new ways to treat different diseases,” said Dani Schultz, director of chemistry, Merck Research Laboratories.

Not too big, not too small: the “Goldilocks” modality

Macrocyclic peptides have been called the “Goldilocks” chemical modality because their intermediate size combines the favorable properties of both small molecules and biologics¹. And thanks to their unique ring shape, macrocyclic peptides can cover more surface area to potentially disrupt protein-protein interactions more so than traditional, linear-shaped peptide therapies.

“The design and invention of macrocyclic peptides is notoriously complicated,” said David Thaisrivongs, director of chemistry in Merck Research Laboratories.

“Similarly, scaling production up for a macrocyclic peptide small molecule, with four to five times the size and complexity of a typical small molecule, represented a bold endeavor.”

David Thaisrivongs
Director of chemistry, Merck Research Laboratories

For Merck, this work started by screening large libraries of cyclic peptides using messenger RNA display technology. This led to the identification of cyclic peptide leads that were optimized using 3-dimensional protein structure-based design and advanced computational techniques. Further molecular iterations and refinements improved the absorption, potency, and stability of the first candidate.

“A diverse, interdisciplinary team of skilled and determined people from across our chemistry organization has dedicated substantial efforts to advancing this science,” said Thaisrivongs.

A peptide renaissance

These macrocyclic peptide discovery efforts may one day allow us to treat diseases that have long evaded traditional small molecule approaches or improve access to medicines previously available only as an injectable.

“Macrocyclic peptides are a new modality and we’re still in the early stages of understanding their potential to impact disease and patient care,” said Schultz.

“There’s no playbook here, we’re innovating and developing new techniques on how to optimize and synthesize macrocyclic peptides — it’s really thrilling for me as a scientist because the potential is huge.”

Dani Schultz
Director of chemistry, Merck Research Laboratories

[1] Beyond 20 in the 21st century: strengths, opportunities, and challenges of non-canonical amino acids in peptide drug discovery. Jennifer L. Hickey; A Dan Sindhikara; B Susan L. Zultanski and Danielle M. Schultz

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Innovation

How we’re collaborating to address antimicrobial resistance – and why we can’t do it alone

Shared commitments like the AMR Action Fund are vital to make progress against this public health threat

September 8, 2023

Antibiotics have transformed health care and saved countless lives. But rising levels of antimicrobial resistance (AMR) can make current antibiotics less effective. There’s no simple solution to the complex problem of AMR, but we’re committed to investing our expertise and resources alongside our partners to get antibiotics to those who need them most. Lives are at risk, and the time to act is now.

Through this groundbreaking partnership of over 20 leading pharmaceutical companies, philanthropies and organizations, we aim to bridge the gap between the innovative early antibiotic pipeline and patients. True to our legacy of preventing and treating infectious diseases, we’re proud of our commitment to invest $100 million over 10 years in the AMR Action Fund. The fund’s collective goal is to bring two to four novel antibiotics to patients and physicians by 2030.

As of early 2023, the AMR Action Fund has invested in five small biotech companies advancing research for new medicines to fight some of the most dangerous bacteria as determined by the U.S. Centers for Disease Control and Prevention and the World Health Organization.

Here are five reasons collaborative efforts are key to addressing AMR:

01.

New antibiotics are urgently needed; however, there are relatively few in development.

The future of antibiotic innovation is at serious risk. Major scientific, regulatory and economic challenges discourage innovation in antibiotics, resulting in a decline in the number of companies conducting antimicrobial R&D. Recognizing there’s no one-size-fits-all solution to the problem, our company and others have suggested a series of policy reforms across several regions of the world. However, time is running out. We need collaboration from policymakers to help antibiotic innovation flourish for decades to come.

02.

Once new antibiotics are approved, they need to be used responsibly.

At Merck, we’re making significant investments to support antimicrobial stewardship (AMS), a broad term for the implementation of evidence-based policies to slow resistance to current antimicrobials. Our investments and partnerships help hospitals around the world develop and implement patient-centered AMS programs that are customized locally based on factors like epidemiology, clinical setting and resource availability to support the responsible prescribing and use of antimicrobials. We also provide significant grant funding to support a wide range of AMS initiatives and collaborations.

Some of our global contributions to AMS include:

Supporting the development of several AMS Centers of Excellence throughout the world.
Helping public health leaders effectively monitor and address emerging AMR infections, promote AMS and customize accepted AMS strategies to meet local needs.
Providing significant grant-funding for numerous investigator-initiated AMS research projects.

03.

Tracking resistance trends and using data to help doctors prescribe the right medicines remains critical.

Our company has been tracking global resistance trends for over 20 years. This data helps doctors prescribe the right medicines. One of the largest and longest-running AMR surveillance programs, our Study for Monitoring Antimicrobial Resistance Trends (SMART) program has collected nearly 500,000 Gram-Negative bacterial isolates from around 220 sites in more than 60 countries since 2002.

We’re also a partner of the AMR Register, a first-ever online platform that allows pharmaceutical companies to securely share data on infection-causing pathogens with researchers, national governments and multilateral organizations working to fight AMR.

04.

AMR extends beyond human health.

The challenge of AMR is multifaceted, and a One Health approach to creating policies is critical to attain optimal health for people, animals and the environment.

When it comes to animal health, vaccines can help minimize the need for antibiotics. Merck Animal Health is one of the largest manufacturers of animal health vaccines, supplying over 102 billion doses each year.

Protecting the environment through responsible manufacturing is another key component of the One Health approach. We work with our partners in the AMR Industry Alliance to inform science-based manufacturing standards to help ensure scrutiny of industry manufacturing supply chains.

05.

The time to act against AMR is now.

With collaboration across the scientific community and policymakers, AMR is preventable.

We all have a role to play as we prepare for the next health crisis. We must act now to put measures in place to ensure we have the antibiotics we need.

“AMR is not a future problem — it’s here now, threatening human, animal and environmental health as we know it. We must take swift, collaborative action to help reduce the risk of AMR before it’s too late,” said Jennifer Zachary, executive vice president and general counsel at Merck and member of the Global Leaders Group on AMR.

To learn more about the investments that the AMR Action Fund is making to help ensure patients and physicians have access to effective antimicrobials –- now and in the future –- please visit their website.

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Patients

Progress in ovarian cancer research starts with patients

Reflecting on the history of clinical research and our inspiration to continue innovating for ovarian cancer patients

August 24, 2023

This article was written by Dr. Scot Ebbinghaus, VP, clinical research.

A history of groundbreaking research

More than sixty years ago, in 1958, British chemist and X-ray crystallographer Dr. Rosalind Franklin died following a two-year fight with ovarian cancer. She was only 37 years old. Her pioneering research provided the key to deciphering the structure and function of DNA — and ultimately the blueprint for life.

In 1962 her collaborators, James Watson, Francis Crick and Maurice Wilkins, were awarded the Nobel Prize for their “discoveries concerning the molecular structure of nucleic acids and its significance for information transfer in living material.” Dr. Franklin’s untimely death denied her the acclaim of this prestigious scientific award (the Nobel Committee does not award the prize posthumously), but her role in this fundamental discovery has been well-documented and is now widely recognized.

Dr. Franklin’s story of a life cut short by ovarian cancer remains all too common. In the U.S., ovarian cancer accounts for more deaths than any other cancer of the female reproductive system.

Even today, advanced ovarian cancer remains one of the most difficult cancers to treat.

Only about one-third of patients with metastatic ovarian cancer survive five years after diagnosis. By contrast, when the cancer is caught early, the odds of surviving at least five years after diagnosis are much better. Unfortunately, only a small percentage of women are diagnosed at an early stage.

It is estimated that:

In 2023, 19,710 women in the U.S. will be diagnosed with ovarian cancer and about 13,270 will die from the disease.
About half of all women in the U.S. who are diagnosed with ovarian cancer are 63 years or older.

Ovarian cancer more often causes signs and symptoms when the disease has spread, but can also cause nonspecific signs and symptoms in the early stages. Ovarian cancer is generally diagnosed after it has spread to other parts of the body.

The most common symptoms of ovarian cancer include:

Bloating
Pelvic pain
Trouble eating or feeling full quickly
Always feeling like you have to urinate, or having to urinate often

These symptoms are also commonly caused by non-cancerous diseases and by other cancers. When they are caused by ovarian cancer, they tend to be persistent and a change from normal.

Helping advance ovarian cancer research

There remains a reason for optimism. The pace of change in cancer treatment has increased dramatically in recent years. Advances in research have given us a deeper understanding of how to target the disease, paving the way for new developments.

At Merck, we’re focused on translating breakthrough science into oncology therapeutics. We recognize that no two patients or cancers are the same, and multiple approaches — therapeutic regimens and mechanisms of action — will be needed to outpace this disease. That’s why we have worked rigorously to expand and diversify our own internal research programs.

There’s still work to be done, but we believe strongly in our potential to transform the way certain cancers are treated. And, we’re constantly inspired to work harder by stories like Dr. Rosalind Franklin’s.

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Health awareness

Endometrial cancer: Understanding the signs and symptoms

Learn more about how you can detect endometrial cancer

August 10, 2023

As we age, it’s important to recognize changes in the body. Irregular periods, postmenopausal bleeding, abnormal discharge, changes to bladder or bowel habits – these shifts can seem like a part of getting older. But for some, these changes can signal a more serious issue, as many mirror the symptoms of gynecologic cancers.

What is endometrial cancer?

Endometrial cancer is the most common cancer of the female reproductive organs in the U.S. It occurs when cancerous cells form in the tissues of the endometrium or inner lining of the uterus.

How can I learn if I’m at risk for endometrial cancer?

While age, family history and lifestyle choices impact the risk of endometrial cancer, conditions that affect the body’s estrogen levels can also play a role. For example:

Hormone replacement therapy for menopause often includes an increase of estrogen to manage menopausal symptoms.
Polycystic ovarian syndrome (PCOS) usually creates higher estrogen levels.
Estrogen modulators may cause the uterine lining to grow.
Certain comorbidities, including obesity and type 2 diabetes, have been linked as risk factors for endometrial cancer. For example, in people with obesity, fat tissue can convert certain hormones into estrogen, which increase the levels in the body.

Studies show Black women are more likely to be diagnosed with endometrial cancer than white women.

What to watch out for:

Abnormal vaginal bleeding
Pelvic pain
Irregular menstrual cycles
Pain during intercourse
Postmenopausal bleeding
Abnormal vaginal discharge
Changes to bowel or bladder habits

How is endometrial cancer diagnosed?

If you’re experiencing any of these symptoms, talk to your doctor about getting screened. Tests to diagnose it may include:

Endometrial biopsy: A thin, flexible tube is inserted into the uterus to collect a tissue sample from the endometrium.
Dilation and curettage: The cervix is dilated to collect tissue from the inner lining of the uterus.
Hysteroscopy: An instrument with a light and lens for viewing is inserted into the uterus to look for abnormal areas.
Ultrasound: A probe is inserted into the vagina to produce images that are used to assess the pelvic organs, including the uterus.

Being diagnosed with endometrial cancer can be scary. But by speaking with your doctor, you can better understand your options and build the best path forward.

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Innovation

Our Q2 2023 earnings report

August 1, 2023

Merck’s (NYSE: MRK) Q2 2023 results reflect sustained underlying growth. Our company announced Q2 worldwide sales of $15.0 billion, an increase of 3% from Q2 2022.

“We continue to make great progress as we advance our broad and deep pipeline, raise the bar of innovation, and bring forward leading-edge science to save and improve lives around the world,” said Rob Davis, chairman and chief executive officer, Merck. “We delivered robust underlying growth during the second quarter and are well positioned to achieve strong full-year results. I am proud of our talented, diverse and dedicated global team that continues to focus on creating value for patients and all our stakeholders now and well into the future.”

Merck anticipates full-year 2023 worldwide sales to be between $58.6 billion and $59.6 billion. Take a look at the infographic below for more details on Q2 2023 results.

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