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FDA approves ovarian cancer treatment

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The FDA has approved a new treatment for ovarian cancer in adults with platinum-resistant disease after one to three earlier systemic treatments.

The approval covers Lifyorli, also known as relacorilant, in combination with the chemotherapy nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients must have received one to three prior systemic treatment regimens, with at least one including bevacizumab.

Lifyorli, developed by Corcept Therapeutics, is the first FDA-approved selective glucocorticoid receptor antagonist. This type of drug blocks the effects of cortisol, a stress hormone that can help tumours resist chemotherapy.

Joseph Belanoff, Corcept’s chief executive officer, said: “It is a privilege to bring forward a new treatment for patients who historically have had few options.

“We have worked for years to demonstrate the potential of cortisol modulation in oncology.

“Today’s approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment.

“We extend our deep appreciation to the patients and healthcare providers who participated in the clinical trials that made this approval possible.”

Approval was based on the ROSELLA trial, which enrolled 381 patients with platinum-resistant ovarian cancer who had received one to three prior lines of therapy, with at least one including bevacizumab.

Patients were randomised one to one to receive either Lifyorli plus nab-paclitaxel or nab-paclitaxel alone. No biomarker selection was required.

The trial met its dual primary endpoints of progression-free and overall survival.

Patients treated with Lifyorli plus nab-paclitaxel saw a 35 per cent reduction in the risk of death compared with patients treated with nab-paclitaxel alone, with median overall survival of 16.0 months compared with 11.9 months, a difference of 4.1 months.

Patients who received Lifyorli plus nab-paclitaxel also saw a 30 per cent reduction in the risk of disease progression compared with patients treated with nab-paclitaxel alone.

The safety of Lifyorli was assessed in a pooled analysis of patients from ROSELLA and the drug’s phase 2 trial.

The prescribing information includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity.

The most common adverse reactions in more than 20 per cent of patients, including laboratory abnormalities, were decreased haemoglobin, decreased neutrophils, fatigue, nausea, diarrhoea, decreased platelets, rash and decreased appetite.

Serious adverse reactions occurred in 35 per cent of patients who received Lifyorli in combination with nab-paclitaxel.

Rob Coleman, of Texas Oncology and special adviser to the president of the GOG Foundation, said: “Data demonstrate that Lifyorli plus nab-paclitaxel provides a clinically meaningful benefit in overall survival for patients with platinum-resistant ovarian cancer and is well tolerated.

“Lifyorli is positioned to become a new standard-of-care treatment.

“Having a new treatment for this advanced, recurrent disease will provide clinicians with a compelling option to help patients with this extremely difficult-to-treat cancer.”

Sarah DeFeo, chief programme officer at Ovarian Cancer Research Alliance, added: “The FDA’s approval of Lifyorli in combination with nab-paclitaxel is welcome news to all of us in the ovarian cancer community.

“We are grateful to everyone who participated in the clinical trials, their families and the physicians who helped advance this urgently needed treatment option for patients with platinum-resistant ovarian cancer.”

Insight

Early PET scan could chemo response in aggressive breast cancer – study

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An early PET scan after one cycle of chemotherapy may help predict how aggressive breast cancer responds to treatment, a study suggests.

Research led by The Institute of Cancer Research, London and King’s College London suggests that an early scan taken after one cycle of chemotherapy could help predict how well a patient’s cancer will respond to treatment.

The study focused on patients with triple-negative breast cancer (TNBC), an aggressive form of the disease in which cancer cells lack receptors for the hormones oestrogen and progesterone, as well as the HER2 protein.

Patients with TNBC are usually treated with chemotherapy prior to surgery. While many respond well, residual disease at surgery, typically around six months later, is associated with a significantly poorer prognosis. Identifying people sooner who are unlikely to respond remains a major clinical challenge.

The research explored whether using PET imaging shortly after treatment begins, rather than relying only on MRI scans later in the treatment process, could provide earlier insight into how a patient’s cancer is responding. Twenty-two patients were recruited, with fourteen undergoing FDG-PET scans before treatment and after the first cycle of chemotherapy.

The findings, published in Clinical Cancer Research, showed that changes seen on PET scans after just one cycle of chemotherapy were strongly associated with subsequent response, including whether there was no detectable cancer, known as a complete response, by the end of treatment. Importantly, early PET response showed stronger associations with treatment outcomes than standard mid-treatment MRI scans in this study.

Being able to identify patients who are not responding well at an early stage could allow clinicians to adjust treatment sooner or consider alternative approaches. These findings may also support future strategies to better tailor treatment intensity to individual patients.

The study also compared two types of PET tracers, FDG and FLT, to determine which was most suitable. While both met the study’s technical criteria, FDG-PET was selected for further evaluation due to its better image quality, greater consistency and wider use in clinical practice.

The research also explored how imaging changes after just one cycle of chemotherapy relate to the body’s immune response to treatment. Biopsies taken before and after the first cycle of chemotherapy showed that an increase in immune cells within the tumour was strongly associated with both early PET changes and improved treatment outcomes.

The researchers emphasise that these findings now need to be validated in larger studies. Future work will aim to confirm these results in broader patient groups and explore more accessible imaging approaches, such as ultrasound, alongside PET and MRI.

Sheeba Irshad, professor of cancer immunology at King’s College London and lead of the Breast Cancer Now KCL Research Unit, said:

“In patients who had PET scans both before treatment and after the first cycle, we found that this early scan could predict whether they were likely to achieve a complete response by the end of treatment. These findings highlight the potential of early imaging to guide treatment decisions, and now need to be validated in larger, modern clinical trials.”

Andrew Tutt, professor of breast oncology at The Institute of Cancer Research, London, said:

“Research that helps us determine early who is already benefitting from standard neoadjuvant chemotherapy and who might benefit from clinical trials to find better treatments is vital. This study shows that FDG-PET may have great value in this regard. We hope to be able to design studies that further investigate and validate these findings.”

The study was supported by funding from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, Breast Cancer Now, Cancer Research UK, and Guy’s and St Thomas’ Charity.

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Cancer

Women unaware of gynaecological cancers

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Only one per cent of women can name all five gynaecological cancers, new research suggests, as 21 women in the UK die every day of the diseases.

The report also found that 31 per cent of women have put off or avoided seeking medical advice for gynaecological symptoms.

It also found that 43 per cent of women invited for cervical screening said barriers had put them off attending, while 18 per cent of respondents aged 25 to 34 who had been invited had never attended.

The five main gynaecological cancers are womb, also called uterine, ovarian, cervical, vulval and vaginal cancer.

The Lady Garden Foundation said that, while progress has been made since the UK government’s 2022 Women’s Health Strategy aimed to improve gynaecological cancer care, significant challenges remain.

John Butler, medical director and trustee at the Lady Garden Foundation, said: “The fact that only one per cent of the population can name the diseases that directly affect half of us underscores a significant awareness gap, impacting individuals’ ability to recognise vital signs and symptoms or seek timely medical help.

“Addressing this isn’t just about awareness; it’s a critical public health priority. Our collective efforts are essential to ensure the latest commitments announced by this government translate into tangible change that saves lives.”

The report said key reasons for delaying medical advice included difficulty making appointments, embarrassment and, for cervical screening, fear of pain or previous bad experiences.

Women also reported challenges within healthcare interactions, including feeling “not taken seriously”, “dismissed” or “not believed” when seeking gynaecological advice.

Jenny Halpern Prince, chief executive and charity co-founder, said: “We frequently hear reports of women feeling ‘not taken seriously,’ ‘dismissed,’ or ‘not believed’ when seeking gynaecological advice.

“These experiences highlight crucial areas where we can improve patient support and trust within our healthcare system, ensuring women receive the empathetic and effective care they need.”

The Lady Garden Foundation said it aims to increase awareness of both the charity and the five gynaecological cancers.

It also aims to serve as a primary entry point for reliable, stigma-free information, helping people understand their bodies, recognise symptoms and overcome barriers to accessing care.

Its Silent No More Garden was unveiled at the RHS Chelsea Flower Show 2026. Designed by Darren Hawkes, the garden serves as a national call to action, using five sculptures to spark conversations, break long-standing taboos and encourage open dialogue about symptoms and preventative care.

Butler said: “Continued focus and collaborative action are essential to progress.

“The ongoing commitment from the government, alongside societal efforts to break down taboos surrounding gynaecological health, are crucial.

“The Lady Garden Foundation is dedicated to being a beacon of information and support, empowering women with the knowledge they need. We urge everyone to learn the signs, speak up, and help us save lives.”

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Fertility

AI could transform ovarian care through personalisation, study finds

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AI could transform ovarian care by personalising cancer and fertility treatment, but more clinical validation is needed before routine use.

A systematic review and meta-analysis found AI models showed high diagnostic accuracy for ovarian cancer when combining data such as ultrasound scans and blood test results.

Across 81 studies, AI models correctly identified ovarian cancer in around nine out of 10 cases, with pooled rates of 89 to 94 per cent.

They were also highly accurate at ruling out ovarian cancer when it was not present, with specificity of 85 to 91 per cent.

The analysis also found that explainable AI tools could predict complete surgical cytoreduction in advanced ovarian cancer.

Complete surgical cytoreduction means removing all visible cancer during surgery, which can be an important goal in treatment planning.

The tools achieved a pooled AUC of 0.87. AUC is a measure of how well a model distinguishes between different outcomes, with higher scores showing stronger performance.

In reproductive medicine, AI algorithms helped physicians optimise ovarian stimulation protocols and predict follicular growth during IVF.

Ovarian stimulation is the use of hormones to encourage the ovaries to produce eggs, while follicles are the small sacs in the ovaries where eggs develop.

The review found AI could reliably model ovarian response in IVF with a pooled AUC of 0.81.

However, researchers said challenges remain in translating promising research findings into routine clinical practice.

They identified substantial variation across studies, driven by retrospective study designs, variable AI systems and a lack of standardised validation.

Only 22 per cent of analysed studies reported prospective, multicentre external validation, where models are tested forward in time across multiple healthcare settings.

The authors called for rigorous validation to help close the gap between research and routine clinical practice, alongside standardised methodological and reporting frameworks, smooth integration with clinical workflow and robust governance to support responsible and ethical AI use.

They concluded: “Artificial intelligence is a transformative force in the management of ovarian conditions.

“In gynaecologic oncology, AI enhances every phase of care, from early detection and accurate diagnosis to prognostic stratification and surgical planning.”

In reproductive medicine, AI personalises ovarian stimulation and refines the diagnosis of heterogenous endocrine disorders such as PCOS.

PCOS, or polycystic ovary syndrome, is a hormonal condition that can affect periods, skin, weight and fertility.

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