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Endometrial cancer patients see new hope as FDA approves 'transforming' immunotherapy drug

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Endometrial cancer patients see new hope as FDA approves 'transforming' immunotherapy drug

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The U.S. Food and Drug Administration (FDA) has approved a new drug for certain adult patients with endometrial cancer.

Jemperli (dostarlimab-gxly) — made by British pharmaceutical company GSK — is intended for people with primary advanced or recurrent forms of the cancer, according to the FDA’s Aug. 1 announcement.

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It is an immunotherapy-based drug, which means it leverages the body’s immune system to attack cancer cells.

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In clinical trials, Jemperli showed an improved progression-free survival and overall survival for all patients, according to Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Florida.

“This class of drugs has been used in the second-line setting,” Slomovitz said — meaning they were only used if a first-line (primary) treatment was not effective or had intolerable side effects.

The FDA has approved a new drug for certain adult patients with endometrial cancer. (iStock)

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“Moving them to first-line [status] here will yield better outcomes.”

This is the third FDA approval this year for immunotherapy in endometrial cancer, the doctor noted.

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“This is great news for our patients,” Slomovitz told Fox News Digital.

“Endometrial cancer has become the leading cause of death over all other gynecologic cancers, including ovarian cancer.”

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Jemperli (dostarlimab-gxly) — made by British pharmaceutical company GSK — is intended for people who have primary advanced or recurrent forms of the cancer. (iStock)

Before the immunotherapy options became available, the only treatment for endometrial cancer was chemotherapy alone, Slomovitz said. 

“These results are game-changing — it is unprecedented to have three approvals in such a short period of time.”

The most common side effects of all immunotherapy drugs are gastrointestinal, endocrine and dermatologic toxicities, the doctor noted.

“These results are game-changing — it is unprecedented to have three approvals in such a short period of time.”

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“Patients should understand that adding immunotherapy to traditional chemotherapy has better results and the toxicity profile is manageable,” he added.

For doctors, Slomovitz emphasized the need to adjust quickly and make the newly approved drug a first-line treatment option for their patients.

GlaxoSmithKline (GSK) is the U.K.-based pharmaceutical company that makes Jemperli. (REUTERS/Dado Ruvic/Illustration/File Photo)

In June, the FDA approved Merck’s Keytruda (pembrolizumab) to be used in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial cancer.

“The Merck trial (pembrolizumab) showed a significant improvement in progression-free survival for all patients,” Slomovitz said.

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In that same month, AstraZeneca’s Imfinzi (durvalumab) was approved for patients with advanced or recurrent disease who have a certain biomarker.

The AstraZeneca trial also showed improved progression-free survival for all patients. 

All trials for the new cancer drugs were run through the GOG Foundation, which is the largest cooperative group for all gynecologic oncology research, Slomovitz noted. 

“The addition of immunotherapy to chemotherapy provided improvement in survival outcomes without a negative impact on quality of life,” an oncologist said. (iStock)

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In the trials, the use of immunotherapy drugs in combination with chemotherapy reduced the risk of disease progression by approximately 70% in patients whose tumors had certain biomarkers.

In other patients without that biomarker, there was still a “clinically and statistically significant improvement in time to progression, which is meaningful for our patients and has now led to FDA approvals in both biomarker settings,” Kathleen N. Moore, M.D., co-director of the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, told Fox News Digital.

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“These studies have transformed outcomes for patients with endometrial cancer and are poised to change the treatment landscape for the better into the future,” she added.

Shannon N. Westin, medical director of the Gynecologic Oncology Center at the University of Texas MD Anderson Cancer Center, said she is “thrilled” to have multiple new options for patients with advanced and recurrent endometrial cancer after years with no new therapies.

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This is the third FDA approval this year for immunotherapy in endometrial cancer, the doctor noted. “This is great news for our patients,” an oncologist told Fox News Digital. (iStock)

“We no longer have to treat everyone in the same cookie-cutter fashion, and can instead employ precision medicine to improve survival for these survivors.”

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“The addition of immunotherapy to chemotherapy provided improvement in survival outcomes without a negative impact on quality of life,” she went on. 

“This is the ideal scenario.”

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Fox News Digital reached out to GSK for comment.

Health

Blood test flags digestive disease risk years before symptoms appear

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Blood test flags digestive disease risk years before symptoms appear

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A simple blood test may detect Crohn’s disease years before symptoms appear, according to a new study reported by SWNS.

Canadian researchers say the discovery could enable earlier diagnosis and potential prevention of the chronic inflammatory bowel disease (IBD).

The test measures the immune system’s response to flagellin, a protein found in gut bacteria. Researchers found that this response is elevated in some people years before Crohn’s develops.

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The findings, published in Clinical Gastroenterology and Hepatology, highlight the “interplay” between gut bacteria and immune system responses as a key step in the disease’s development, per the SWNS report.

Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that causes persistent digestive symptoms, pain and fatigue, significantly affecting quality of life. Its incidence among children has doubled since 1995, according to official figures.

Crohn’s disease is a type of inflammatory bowel disease (IBD) that causes swelling and irritation of the tissues, called inflammation, in the digestive tract.  (iStock)

The presence of flagellin antibodies long before symptoms appear suggests that the immune reaction may help trigger the disease, according to research leader Dr. Ken Croitoru, clinician-scientist and professor of medicine and immunology at the University of Toronto. 

A better understanding of this early process could lead to improved prediction, prevention and treatment, the expert said.

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“We haven’t cured anybody yet, and we need to do better.”

“With all the advanced biologic therapy we have today, patients’ responses are partial at best,” Croitoru told SWNS. “We haven’t cured anybody yet, and we need to do better.”

MISUNDERSTOOD ILLNESS LEAVES MILLIONS EXHAUSTED, WITH MOST CASES UNDIAGNOSED

“We wanted to know: Do people who are at risk, who are healthy now, have these antibodies against flagellin?” he said. “We looked, we measured, and yes indeed, at least some of them did.”

This new research is part of the Genetic, Environmental and Microbial (GEM) Project, which has followed more than 5,000 healthy first-degree relatives of people with Crohn’s disease worldwide since 2008. The project collects genetic, biological and environmental data to better understand how the disease develops.

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The presence of flagellin antibodies long before symptoms appear suggests that the immune reaction may help trigger the disease, according to the lead researcher. (iStock)

The study followed 381 first-degree relatives of Crohn’s patients, 77 of whom later developed the disease. Of those, more than 30% had elevated antibody responses.

The responses were strongest in siblings, underscoring the role of shared environmental exposure, researchers said.

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So far, 130 of the study participants have developed Crohn’s, giving researchers a rare opportunity to study its earliest stages. The average time from blood sample collection to diagnosis was nearly 2-½ years.

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Previous GEM research showed that an inflammatory immune response targeting gut bacteria can appear long before the disease develops. 

The study followed 381 first-degree relatives of Crohn’s patients, 77 of whom later developed the disease. (iStock)

In healthy people, gut bacteria coexist peacefully and play an essential role in digestive health — but in Crohn’s patients, the immune system appears to mount an abnormal response against the microbes, experts say.

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The Canadian team also confirmed that this pre-disease immune response was associated with intestinal inflammation and gut barrier dysfunction, both hallmarks of Crohn’s disease. 

The study did have some limitations, including that it did not include experiments to show exactly how the immune response might lead to Crohn’s disease.  (iStock)

Research team member Dr. Sun-Ho Lee, a gastroenterologist, commented that this new study supports the idea of designing a flagellin-directed vaccine for certain high-risk individuals to prevent the disease, according to SWNS.

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The study did have some limitations, including that it did not include experiments to show exactly how the immune response might lead to Crohn’s disease. 

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As a result, the researchers could not determine the biological steps linking the immune reaction to the onset of the illness. “Further validation and mechanistic studies are underway,” they noted.

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Simple daily habit may help ease depression more than medication, researchers say

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Simple daily habit may help ease depression more than medication, researchers say

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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).

A new study suggests that exercise can treat depression just as effectively as therapy and antidepressants.

A Cochrane review looked at 73 randomized controlled trials involving nearly 5,000 adults with a depression diagnosis. The studies compared exercise with either other active treatments — such as therapy or medication — or with “inactive interventions,” like being placed on a wait list or in a control group.

The London-based team discovered that exercise may be “moderately effective” compared to no therapy in reducing depression symptoms, according to a press release.

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EXERCISE AFFECTS THE HEART IN A HIDDEN, POWERFUL WAY BY REWIRING NERVES, STUDY FINDS

“There is probably little to no difference in depressive symptoms between people undertaking exercise and those receiving psychological therapy,” the authors noted in a study discussion on Cochrane’s website, and “there may be little to no difference in depressive symptoms between people doing exercise and those taking antidepressants.”

The analysis discovered that exercise may be “moderately effective” compared to no therapy in reducing depression symptoms. (iStock)

The review found that light- to moderate-intensity exercise was more beneficial for easing depression symptoms than vigorous exercise.

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No single type of physical activity stood out as the best, but mixed programs that included resistance training appeared to be “more effective” than just aerobic exercise. 

Some forms of exercise, like yoga and stretching, were not included in the analysis, but are areas to be further researched, the review noted.

Mixed exercise programs and resistance training appeared to be “more effective” in easing depression symptoms than just aerobic exercise. (iStock)

Professor Andrew Clegg, lead author of the review, wrote in a statement that exercise “appears to be a safe and accessible option for helping to manage symptoms of depression.”

“This suggests that exercise works well for some people, but not for everyone, and finding approaches that individuals are willing and able to maintain is important,” he said.

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Study limitations and risks

The researchers noted that there was a high risk of bias in some of the studies included in the review, and noted that the long-term effects of exercise on depression symptoms remain uncertain.

COMMON SPICE MAY BEAT DEPRESSION AND BOOST SEXUAL HEALTH, DOCTOR SAYS

Clegg noted that “larger, high-quality studies” are needed to determine which types of exercise work best and whether the benefits last over time.

The comparison between exercise and other treatments and how they benefit people’s quality of life were also “inconsistent and uncertain.”

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“Adverse events from exercise were not common,” the researchers mentioned. “The small number of participants who experienced them usually reported muscle and joint problems or worsening of depression.”

About 21 million U.S. adults had at least one major depressive episode in a recent year — equivalent to roughly 8.3% of all U.S. adults, according to the National Institutes of Health. (iStock)

“Future research should focus on improving the quality of the studies, working out which characteristics of exercise are effective for different people, and ensuring different types of people are included in the studies so that health equity issues can be considered,” they went on.

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About 21 million U.S. adults had at least one major depressive episode in a recent year — equivalent to roughly 8.3% of all U.S. adults, according to the National Institute of Mental Health.

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Depression symptoms include feelings of sadness, hopelessness, anxiety, guilt or irritability, as well as loss of interest or pleasure in hobbies and activities. Fatigue, poor concentration, sleep disturbances, appetite changes and social withdrawal are also red flags, in addition to thoughts about dying or suicidal ideations. 

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The condition is most often treated by antidepressant medications and psychological therapies, such as talk therapy. Anyone who needs help should consult their doctor.

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4 Mistakes People Make When Starting a GLP-1 That Can Stall Weight Loss—Plus How to Maximize Your Results

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4 Mistakes People Make When Starting a GLP-1 That Can Stall Weight Loss—Plus How to Maximize Your Results


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4 Mistakes People Make When Starting a GLP-1 That Can Stall Weight Loss | Woman’s World




















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