Connect with us

Cancer

Treatment for breast cancer-related hot flashes sees positive trial results

Published

on

A treatment for breast cancer-related vasomotor symptoms (VMS) – known as hot flashes – has seen positive Phase 3 trial results in women with breast cancer or at high risk of developing breast cancer.

The Phase 3 study investigated the treatment, called elinzanetant, as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy.

According to Bayer, which developed the treatment, elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe hot flashes compared to placebo.

The study also met secondary endpoints, Bayer said, demonstrating reductions in severity of symptoms and frequency reduction, along with improvements of sleep disturbances and menopause-related quality of life at week 12 compared to placebo.

“Elinzanetant has consistently demonstrated positive results across all four Phase III clinical trials that assessed the efficacy and safety for the treatment moderate to severe vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy,” said Dr. Christian Rommel, head of R&D at Bayer.

“Importantly, OASIS 4 is the first pivotal international study to assess the safety and efficacy of a non-hormonal treatment approach for women with or at high risk of breast cancer who are suffering from VMS caused by adjuvant endocrine therapy, reaffirming our commitment at Bayer to advancing innovative treatments for the different needs of women and their health.”

“For women undergoing endocrine therapy against breast cancer, menopausal symptoms like VMS and sleep disturbances are very common and can significantly affect quality of life, potentially impacting treatment adherence,” said Dr. Fatima Cardoso, principal investigator of OASIS 4, from Lisbon, Portugal.

“The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.”

Based on the positive results from the Phase 3 clinical development programme, Bayer has confirmed it has submitted applications for marketing authorisations in the US, EU and other markets around the world.

News

Swab-based endometrial cancer test wins place in German national guideline

Published

on

WID-easy, the only non-invasive triage test for endometrial cancer in routine use in a European public health system, has been cited in Germany’s highest-tier clinical guidance; a marker that non-invasive detection is reaching clinical maturity.

The vaginal-swab test designed to spare women unnecessary invasive procedures has been referenced in the updated German S3 Guideline on Endometrial Cancer, its maker Sola Diagnostics has announced.

The Austria-based women’s-health diagnostics company behind the WID-easy Test, said the test now features in the recommendations-supporting background text of the guideline’s latest version (v4.0, May 2026; AWMF 032-034OL), in Section 4.3.

The S3 designation is the highest evidence- and consensus-based tier in the German clinical guideline system, broadly comparable in standing to NICE guidance in the UK, and is widely drawn on in clinical practice, reimbursement and liability assessments.

In Section 4.3, the guideline cites four peer-reviewed validation studies of the WID-easy Test and credits it with a sensitivity of more than 95 per cent and a negative predictive value of at least 99.7 per cent.

It describes a fall in invasive workup from 19 to two dilatation-and-curettage (D&C) procedures per cancer detected when compared with transvaginal ultrasound alone, assuming a realistic 3.4 per cent cancer prevalence in women with postmenopausal bleeding, and states that the test has the potential to improve the diagnostic workup of women with peri- and post-menopausal bleeding by cutting the rate of invasive procedures.

A growing burden, an imperfect standard

Endometrial cancer is the most common gynaecological cancer in high-income countries, and its incidence is rising, driven by ageing populations and increasing obesity, making it one of the fastest-growing cancer burdens in women’s health.

A number of groups are now developing non-invasive tests for earlier detection. The current standard, transvaginal ultrasound, is an imperfect triage tool: it misses serous carcinomas and performs especially poorly in black women, a group with disproportionately high endometrial-cancer mortality.

WID-easy has been validated prospectively across multiple cohorts, including a dedicated cohort of black women in Ghana (Ken-Amoah et al., 2025).

Adopted in routine care

WID-easy is the only endometrial-cancer triage test in Europe with real-world adoption in a public health system. It is UKCA-marked and in use across NHS pilot sites in England and Scotland, and is delivered through commercial laboratory partners across the DACH region of Austria, Germany and Switzerland. Its UK pivotal study, EASY-CARE, is funded by a competitively awarded NIHR i4i grant.

The postmenopausal bleeding pathway has been singled out for change across three UK Government strategy documents published in 2026 — the National Cancer Plan for England (DHSC), the renewed Women’s Health Strategy for England (DHSC) and the National HealthTech Access Programme (NICE).

The NICE initiative names speeding up access to better tools for detecting endometrial cancer in women with unexplained bleeding as one of only four priority areas.

WID-easy is the only non-invasive endometrial-cancer triage test that is UKCA-marked and commercially available for NHS use today, with no competing molecular test yet on the market.

“Seeing WID-easy referenced in a guideline of this standing confirms that the science behind non-invasive endometrial cancer detection has reached clinical maturity,” said Prof Martin Widschwendter, founder and member of the scientific advisory board at Sola Diagnostics.

“Our goal has always been to spare women unnecessary invasive procedures without missing the cancers that matter — and to do so equitably, across all populations.”

The WID-easy Test detects and triages endometrial cancer from a vaginal swab using DNA methylation. It is built on the WID-qEC biomarker, exclusively licensed from University College London Business and complemented by Sola’s own patent portfolio. The same methylation platform underpins a pipeline of further tests in cervical, ovarian and breast cancer.

Continue Reading

Adolescent health

HPV vaxx ‘almost eliminates’ risk of death in young women – study

Published

on

The HPV vaccine has cut the risk of dying from cervical cancer before age 30 to almost zero among those vaccinated at 12 or 13, research suggests.

The first study of its kind found that deaths have fallen sharply since school-age girls began being offered the jab in 2008, with around 200 lives saved in England so far.

Between 2020 and 2024, no cervical cancer deaths were recorded among women aged 20 to 24, the first time this had happened over a five-year period.

Without vaccination, around 23 deaths would have been expected.

Professor Peter Sasieni, lead researcher at Queen Mary University of London, said: “It’s incredible to think that a single jab can almost eliminate a particular type of cancer.”

Around 3,300 people are diagnosed with cervical cancer each year in the UK, making it the 14th most common cancer among women.

Human papillomavirus, or HPV, is thought to cause 99 per cent of cervical cancer cases. The virus is spread through close skin-to-skin contact.

Most HPV infections clear up without causing problems, but some can cause abnormal cell changes that may lead to cancer years later.

The study’s authors expect deaths from cervical cancer to continue falling as more people receive the jab and vaccinated generations grow older.

Cancer Research UK, which funded the research, called the findings an “incredible milestone” but warned that vaccination rates in England remained below recommended levels.

Michelle Mitchell, chief executive of Cancer Research UK, said: “We know the HPV vaccine is extremely effective at stopping cervical cancer before it starts and for the first time these findings show it is saving lives.”

Professor Sasieni, who specialises in cancer epidemiology at Queen Mary University of London, described the reduction in deaths since the vaccine was introduced as the “tip of the iceberg”.

Cancer epidemiology examines patterns of cancer and how the disease affects different groups of people.

He said: “As vaccinated generations grow older, we’ll see many more lives saved from cervical cancer.

“New research shows just how vital it is to keep HPV vaccination levels high so more people are protected.”

The UK government has pledged to eliminate cervical cancer as a public health problem by 2040.

However, the latest figures show vaccination rates have fallen below recommended levels.

UK Health Security Agency data shows that 76 per cent of girls in England were vaccinated by the age of 15 in 2024-25, well below the 90 per cent level the World Health Organization says is needed to eliminate cervical cancer.

Mitchell said: “It’s essential that the UK Government and health systems urgently address this with targeted action to reach communities where uptake is the lowest.”

Continue Reading

Diagnosis

Vaccine could prevent some people from developing ovarian cancer

Published

on

A vaccine trial will test whether an mRNA jab can help stop precancerous cells developing into bowel and ovarian cancer in people with Lynch syndrome.

The first stage is due to launch this summer and will assess whether the jab can train the immune system to recognise and eliminate precancerous cells before cancer develops.

Around 175,000 people in England have Lynch syndrome, but only five per cent, or around 10,000 people, know they have it.

The inherited condition increases the risk of developing bowel cancer by 80 per cent and is linked to around 1,100 bowel cancer cases each year.

Lynch syndrome is also linked to a far higher risk of bowel, womb and ovarian cancer, alongside other types including stomach, pancreatic, kidney and skin cancer.

While the syndrome does not directly cause cancer, the genetic changes can lead to more abnormal cells developing, which then multiply and increase the risk of cancers such as bowel, prostate and endometrial cancer.

It is caused by an alteration in a mismatch repair gene. Carriers do not have any symptoms.

The new Intercept-Lynch trial is part of a scientific collaboration between the University of Oxford and Moderna, while Cancer Research UK has backed the vaccine’s development.

Once patients receive the new mRNA-4194 jab, experts will analyse their immune responses, assess the best dose and check whether the jab is safe.

The second phase of the study will include multiple centres across the UK, including Oxford, and is expected to begin in 2027.

The aim of the trial is to train the immune system with a vaccine to recognise abnormalities and stop them developing into cancer.

Professor David Church, Cancer Research UK senior cancer research fellow in the University of Oxford’s centre for human genetics and lead investigator of the trial, said: “People with Lynch syndrome are at risk of cancers over their entire lives.

“So, it’s very common, for instance, a woman to have a first cancer of her womb, and then some years later have a bowel cancer, or vice versa.

“The targets we’ve chosen for the vaccine were chosen based on their sharedness across multiple cancer types in Lynch syndrome, so we think they should provide broad protection, if the vaccine works.”

In people with Lynch syndrome, mutations can build up, making the cells containing them more likely to turn into cancerous cells.

However, those mutations can be made visible to the immune system and, with enough stimulation, the immune system can attack the abnormal cells and stop cancer from forming.

Professor Church said the mRNA jab acts as “an instruction manual” for the body to attack precancerous cells.

He added that, as with many vaccines, patients may need a booster jab at some stage.

On whether similar approaches could help prevent cancers not caused by Lynch syndrome, Professor Church said: “In terms of proof of principle that we can train the immune system to recognise these cancer-associated alterations and enhance the immune response against them to prevent these pre-cancers or prevent the progression of pre-cancer to cancer, that proof of principle should give us insights that are generalisable.”

David Berman, chief development officer at Moderna, said: “By applying mRNA technology earlier in the patient journey, we aim to harness the immune system when it can have the greatest impact.

“We are proud to bring this innovation to the UK, building on our long-standing collaboration with leading UK institutions to advance mRNA research and development.”

Continue Reading

Trending

Copyright © 2025 Aspect Health Media Ltd. All Rights Reserved.