Category: Cancer

Hot Flush Treatment has Anti-breast Cancer Activity, Study Finds

Photo by engin akyurt on Unsplash

A drug mimicking the hormone progesterone has anti-cancer activity when used together with conventional anti-oestrogen treatment for women with breast cancer, a new Cambridge-led trial has found.

In the two-week window that we looked at, adding a progestin made the anti-oestrogen treatment more effective at slowing tumour growth. What was particularly pleasing to see was that even the lower dose had the desired effectRebecca Burrell

A low dose of megestrol acetate (a synthetic version of progesterone) has already been proven as a treatment to help patients manage hot flushes associated with anti-oestrogen breast cancer therapies, and so could help them continue taking their treatment. The PIONEER trial has now shown that the addition of low dose megestrol to such treatment may also have a direct anti-cancer effect.

Around three-quarters of all breast cancers are ER-positive. This means the tumours are abundant in a molecule known as an oestrogen receptor, ‘feeding’ on the oestrogen circulating in the body. These women are usually offered anti-oestrogens, medication that reduces level of oestrogen and hence deprives the cancer of oestrogen and inhibits its growth. However, reducing oestrogen levels can bring on menopause-like symptoms, including hot flushes, joint and muscle pain, and potential bone loss.

In the PIONEER trial, post-menopausal women with ER-positive cancers were treated with an anti-oestrogen with or without the progesterone mimic, megestrol. After two weeks of treatment, those that received the combination saw a greater decrease in tumour growth rates compared to those treated with an anti-oestrogen only.

Although further work is required in larger patient cohorts and over a longer period of time to confirm the findings, researchers at the University of Cambridge say the trial suggests that megestrol could help improve the lives of thousands of women for whom anti-oestrogen medication causes uncomfortable side-effects and can lead to some women stopping taking the medication.

PIONEER was led by Dr Richard Baird from the Department of Oncology at the University of Cambridge and Honorary Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust (CUH). He said: “On the whole, anti-oestrogens are very good treatments compared to some chemotherapies. They’re gentler and are well tolerated, so patients often take them for many years. But some patients experience side effects that affect their quality of life. If you’re taking something long term, even seemingly relatively minor side effects can have a big impact.”

Some ER-positive breast cancer patients also have high levels of another molecule, known as progesterone receptor (PR). This group of patients also respond better to the anti-oestrogen hormone therapy.

To explain why, Professor Jason Carroll and colleagues at the Cancer Research UK Cambridge Institute used cell cultures and mouse models to show that the hormone progesterone stops ER-positive cancer cells from dividing by indirectly blocking ER. This results in slower growth of the tumour. When mice treated with anti-oestrogen hormone therapy were also given progesterone, the tumours grew even more slowly.

Professor Carroll, who co-leads the Precision Breast Cancer Institute and is a Fellow of Clare College, Cambridge, said: “These were very promising lab-based results, but we needed to show that this was also the case in patients. There’s been concern that taking hormone replacement therapy – which primarily consists of oestrogen and synthetic versions of progesterone (called progestins) – might encourage tumour growth. Although we no longer think this is the case, there’s still been residual concern around the use of progesterone and progestins in breast cancer.”

To see whether targeting the progesterone receptor in combination with an anti-oestrogen could slow tumour growth in patients, Dr Baird and Professor Carroll designed the PIONEER trial, which tested adding megestrol, a progestin, to the standard anti-oestrogen treatment letrozole.

A total of 198 patients were recruited at ten UK hospitals, including Addenbrooke’s Hospital in Cambridge, and randomised into one of three groups: one group received only letrozole; one group received letrozole alongside 40mg of megestrol daily; and the third group received letrozole plus a much higher daily dose of megestrol, 160mg. In this ‘window of opportunity’ trial, treatment was given for two weeks prior to surgery to remove the tumour. The percentage of actively growing tumour cells was assessed at the start of the trial and then again before surgery.

In findings published today in Nature Cancer, the team showed that adding megestrol boosted the ability of letrozole to block tumour growth, with comparable effects at both the 40mg and 160mg doses.

Joint first author Dr Rebecca Burrell from the Cancer Research UK Cambridge Institute and CUH said: “In the two-week window that we looked at, adding a progestin made the anti-oestrogen treatment more effective at slowing tumour growth. What was particularly pleasing to see was that even the lower dose had the desired effect.

“Although the higher dose of progesterone is licenced as an anti-cancer treatment, over the long term it can have side effects including weight gain and high blood pressure. But just a quarter of the dose was as effective, and this would come with fewer side effects. We know from previous trials that a low dose of progesterone is effective at treating hot flushes for patients on anti-oestrogen therapy. This could reduce the likelihood of patients stopping their medication, and so help improve breast cancer outcomes. Megestrol – the drug we used – is off-patent, making it a cost-effective option.”

Because women in the trial were only given megestrol for a short period of time, follow-up studies will be needed to confirm whether the drug would have the same beneficial effects with reduced side-effects over a longer period of time.

The research was funded by Anticancer Fund, with additional support from Cancer Research UK, Addenbrooke’s Charitable Trust and the National Institute for Health and Care Research Cambridge Biomedical Research Centre.

Personalised and precise cancer treatments underpin the focus of care at the future Cambridge Cancer Research Hospital. The specialist facility planned for the Cambridge Biomedical Campus will bring together world-leading researchers from the University of Cambridge and its Cancer Research UK Cambridge Centre and clinical excellence from Addenbrooke’s Hospital under one roof in a brand-new NHS hospital.

Reference

Burrell, RA & Kumar, S, et al. Evaluating progesterone receptor agonist megestrol plus letrozole for women with early-stage estrogen-receptor-positive breast cancer: the window-of-opportunity, randomized, phase 2b, PIONEER trial. Nature Cancer; 5 Jan 2026: DOI: 10.1038/s43018-025-01087-X

Republished from University of Cambridge under a Creative Commons licence.

Read the original article.

Cipla Partners with ImmunoACT to Launch New CAR-T Cell Therapy for Blood Cancers in Africa

SAG Leukaemia. Credit: Scientific Animations CC0

Cipla Limited (BSE: 500087; NSE: CIPLA; and hereafter referred to as “Cipla”), through its subsidiary Medpro Pharmaceutica, has entered into an exclusive license and supply agreement with Immunoadoptive Cell Therapy Private Limited (ImmunoACT). Under this partnership, Cipla will commercialise talicabtagene autoleucel, India’s first indigenously developed CAR-T cell therapy, in the Republic of South Africa, Algeria, and Morocco.

Talicabtagene autoleucel (the product) is an autologous (of a patient’s own blood sample) anti-CD19 CAR-T indicated for the treatment of patients with relapsed or refractory B-cell Non-Hodgkin’s Lymphoma (B-NHL) and B-cell Acute Lymphoblastic Leukaemia (B-ALL) who have failed standard lines of therapy. Administered to over 500 patients in India, the therapy has demonstrated high efficacy, durable responses, and a well‑tolerated safety profile, leading to reduced ancillary healthcare costs.

As part of this collaboration, ImmunoACT will manufacture the product and Cipla will commercialise in the licensed African territories, thereby expanding access of this revolutionary new treatment to markets currently with unmet needs. 

Commenting on the partnership, Achin Gupta, Managing Director and Global CEO Designate, Cipla Limited, said, “Our collaboration with ImmunoACT reinforces Cipla’s vision of leveraging cutting-edge science to deliver transformative and affordable treatments, especially for patients with critical healthcare needs. By introducing CAR-T therapy in Africa, we aim to bring world-class innovation closer to patients and strengthen our commitment to accessible healthcare in the region.”

Adding on, Paul Miller, Chief Executive Officer of Cipla Africa, said, “We are proud to be at the forefront of efforts to bring CAR-T cell therapy to Africa. This collaboration not only advances our oncology portfolio but also reinforces Cipla’s mission of making next-generation therapies accessible to patients worldwide.”

Dr. Rahul Purwar, ImmunoACT’s Founder & Chairman and a professor of the Indian Institute of Technology (IIT), Bombay, said, “Our mission has always been to innovate and make cell & gene therapies accessible and affordable, addressing the significant unmet medical needs across the globe. This strategic partnership with Cipla seeks to accelerate our endeavours; ensuring that patients with B-cell cancers have a fighting chance at a durable remission, with our CAR-T platform.”   

About CAR-T cell therapy:

CAR T-cell therapy is a groundbreaking form of immunotherapy that uses a patient’s own immune cells to fight the disease. Doctors collect immune cells (T cells) from the patient, reprogram them to identify and destroy cancer cells, and then return them to the body, enabling a targeted and personalized approach to treatment.

About Cipla

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Sep’25), 2nd Largest in the pharma prescription market in South Africa (IQVIA MAT Aug’25), and 4th largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Aug’25). For over nine decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.

About ImmunoACT

As pioneers of India’s first fully integrated CAR-T cell therapy platform, ImmunoACT (Immunoadoptive Cell Therapy Private Limited), develops and manufactures accessible, affordable cutting-edge gene-modified cell therapies for blood cancers and solid tumours. With NexCAR19™, India’s first CAR_T cell therapy (developed in collaboration with the Indian Institute of Technology, Bombay and Tata Memorial Centre) commercially approved in India having unprecedentedly transformed the treatment landscape in refractory/relapsed B-cell malignancies, ImmunoACT also has a robust pipeline including a clinical-stage BCMA-directed CAR-T for multiple myeloma, and solid tumour CAR-Ts under development. The company is accelerating its mission to expand global access to life-saving cell and gene therapies through strategic partnerships.

Electrotherapy may be a Promising New Glioblastoma Treatment

Photo by Anna Shvets

Electrotherapy using injectable nanoparticles delivered directly into the tumour could pave the way for new treatment options for glioblastoma, according to a new study from Lund University in Sweden.

Glioblastoma is the most common and most aggressive form of brain tumour among adults. Even with intensive treatment, the average survival period is 15 months. The tumour has a high genetic variation with multiple mutations, which often makes it resistant to radiation therapy, chemotherapy and many targeted drugs. The prognosis for glioblastoma has not improved over the past few decades despite extensive research.

Electrotherapy – a new treatment method

Electrotherapy offers another strategy to combat solid tumours. Using short, strong electric pulses (irreversible electroporation), non-reversible pores are created in the cancer cells leading to their death. The body’s immune system is simultaneously stimulated. The problem is that surgery is required to place the stiff metal electrodes that are necessary for the treatment. In sensitive tissue, in the brain for example, this often entails a very difficult procedure, which has led to strict criteria regarding which patients can be treated. Johan Bengzon is a researcher in glioblastoma and adjunct professor at Lund University, and consultant in neurosurgery at the Skåne University Hospital. He regularly treats patients with glioblastoma and is frustrated by the limited treatment options.

“The short distance between the hospital and the University in Lund facilitates cooperation and that’s why I contacted research colleagues to find out if injectable electrodes could be an alternative solution in electrotherapy,” says Johan Bengzon.

Said and done. The research team, with Amit Singh Yadav, Martin Hjort, and Roger Olsson at the helm, had previously used nanoparticles to form injectable and electrically conductive hydrogels to control brain signalling and heart contractions. It is aminimally invasive method in which the particles are injected using a thin syringe directly into the body. The particles break down after the treatment and thus do not need to be surgically removed. Perhaps the same technology could be used to destroy tumour cells in glioblastoma. 

“After surgical treatment, unfortunately the glioblastoma tumour often returns on the outer edge of the area operated on. By drop casting the nanoparticles into the tumour cavity after an operation, we could electrify the edges while the immune system is also activated. In animal models the procedure, due to this irreversible electroporation, led to tumours being wiped out within three days,” says Roger Olsson, professor of chemical biology and drug development at Lund University, who led the study. 

Promising results – but a long way to the patient

The prospects are good and the researchers are very hopeful for the future, even though there is a long way to go before it becomes a clinical reality. The challenge is now to test the method on larger tumours. 

“We have seen that the electrode is well received in the brain. We have not noted any problems relating to side effects and after 12 weeks the electrode disappeared by itself as it’s biodegradable. The technology combines direct tumour destruction with activation of the immune system and can be an important step towards more effective treatment of glioblastoma,” concludes Amit Singh Yadav, researcher at Lund University and first author of the study. 

Source: Lund University

Childhood Leukaemia Aggressiveness Depends on Timing of Genetic Mutation

Credit: National Cancer Institute

A team of researchers at the Icahn School of Medicine at Mount Sinai has uncovered why children with the same leukaemia-causing gene mutation can have dramatically different outcomes: it depends on when in development the mutation first occurs.  

The study, led by Elvin Wagenblast, PhD, Assistant Professor of Oncological Sciences, and Pediatrics, at the Icahn School of Medicine at Mount Sinai, was published in Cancer Discovery. It shows that leukemia beginning before birth is often more aggressive, grows faster, and is harder to treat. This adds a missing dimension to precision medicine for childhood leukaemia. 

Dr. Wagenblast and his team at the Wagenblast Lab set out to answer a central question about how a normal blood stem cell can become cancerous. They applied cutting-edge CRISPR/Cas9 genome-editing approaches in human primary blood stem cells to model different developmental stages of acute myeloid leukaemia, one of the most aggressive types of blood cancer. 

Using CRISPR technology, the team induced the NUP98::NSD1 fusion oncoprotein, a cancer-promoting protein created when two genes abnormally fuse, into human blood stem cells from multiple developmental stages, ranging from prenatal to postnatal, adolescence, and adulthood. This approach created the first humanised experimental model that tracks how the same mutation behaves differently depending on when in life it arises. 

The results were striking: stem cells produced during prenatal development transformed easily into leukaemia, creating a highly aggressive and more primitive form of leukaemia. Stem cells produced postnatally became increasingly resistant to transformation and required additional mutations to become cancerous. Prenatal-origin leukaemia stem cells, which are abnormal blood stem cells that arise before birth and can cause certain childhood leukaemias, were more dormant (quiescent) and relied heavily on certain energy sources specific to the cancer state, which were not seen in the leukaemias that originated later in life. Although these prenatal leukaemia stem cells were more dormant, this quiescent state makes them harder to eliminate with standard treatments, helping explain why prenatal-origin leukaemias behave more aggressively, despite identical genetics. 

By analysing single-cell gene expression data from their models, the investigators identified a prenatal gene signature that predicts whether a child’s leukaemia likely began before birth. In patients, this signature strongly correlated with significantly worse clinical outcomes. 

“This work tells us that age matters at the cellular level,” said Dr Wagenblast. “The same mutation behaves very differently depending on when it happens. Understanding this gives us a new way to identify the highest-risk patients and to tailor therapies that go beyond standard genetic classifications.” 

The team tested therapies against the most aggressive leukaemia stem cells and discovered that these cells were especially vulnerable to venetoclax, a Food and Drug Administration-approved drug already used in the clinic. Venetoclax-based combinations, including with standard chemotherapy, significantly reduced aggressiveness in the experimental models. 

“These findings give clinicians mechanistic support to use venetoclax combinations in NUP98-rearranged acute myeloid leukaemia, particularly in younger patients whose disease likely started before birth,” said Dr Wagenblast. 

Understanding when leukaemia begins may help doctors choose more effective therapies earlier, reducing trial-and-error approaches and preventing resistance and relapse later on. 

Conceptually, the study shifts how scientists understand childhood cancer. The developmental timing of the first mutation is not a minor detail. It fundamentally shapes disease biology, treatment resistance, and relapse risk. 

The research opens the door to new diagnostic tools that can identify prenatal-origin leukaemias, venetoclax-based combination therapies that more precisely target vulnerable leukaemia stem cells, and clinical trials that incorporate developmental timing into risk assessment. 

Next, the team plans to develop therapies that more directly target the metabolic program unique to prenatal-origin leukaemias, with the goal of selectively eliminating leukaemia stem cells while sparing healthy blood stem cells. 

Source: Mount Sinai

Tec-Dara Combo More Effective for Relapsed or Refractory Multiple Myeloma

Depiction of multiple myeloma. Credit: Scientific Animations

Patients with relapsed or refractory (R/R) multiple myeloma who received a combination of teclistamab, a bispecific monoclonal antibody, and daratumumab, a CD38-directed monoclonal antibody, were 83% more likely to be alive without disease progression compared with those who received standard second-line therapies at a median of nearly 35 months of follow-up, according to the results of a new trial presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

The trial is the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment for multiple myeloma. Based on the findings, researchers suggest the combination of teclistamab and daratumumab, known as Tec-Dara, could represent a new standard of care for R/R multiple myeloma.

“We were surprised by the efficacy data because we didn’t expect such a magnitude of benefit,” said lead study author María-Victoria Mateos, MD, PhD, physician in the haematology department and professor of medicine at the University of Salamanca in Spain. “These are the best data we’ve seen in patients with R/R multiple myeloma after one line of therapy. Patients will live longer overall and with no worsening of quality of life.”

Multiple myeloma is a cancer that causes excessive production of plasma cells, crowding out the production of other types of blood cells and harming the body’s ability to fight infections. It is most common in older adults. Patients who relapse or experience an incomplete response to initial treatment often have their cancer return after subsequent therapies, pointing to a need for improved second-line treatments.

Teclistamab is approved by the U.S. Food and Drug Administration for R/R multiple myeloma after at least four prior lines of therapy. Daratumumab is a therapy targeting the CD38 protein that has been approved for use in combination with other therapies for newly diagnosed and R/R multiple myeloma. Laboratory studies have suggested that teclistamab and daratumumab may work synergistically to eradicate cancer to a greater extent than either agent individually.

To test this hypothesis, researchers randomized 587 patients with R/R multiple myeloma to receive either Tec-Dara or standard second-line therapies. For patients in the control arm, treating physicians chose between two standard three-agent combination therapies which included daratumumab with dexamethasone plus either pomalidomide or bortezomib (known as DPd or DVd, respectively).

Study participants had a median age of 64 with a range of 25-88, and all patients were R/R after one to three prior lines of therapy. Participants remained on their assigned treatment regimen unless they experienced intolerable adverse events, and were followed for a median of nearly 35 months.

The 36-month rate of progression-free survival, the study’s primary endpoint, was achieved in 83.4% of participants who received Tec-Dara and 29.7% of those receiving DPd/DVd, a substantial improvement in favor of Tec-Dara. This benefit was consistent across subgroups of patients by age, prior treatment, tumor genetics, and other factors.

In addition to being a highly efficacious treatment for R/R multiple myeloma as early as the first relapse, researchers noted that the Tec-Dara combination could be more accessible than other second-line therapies for multiple myeloma as it could be delivered in community settings, not just academic centers.

Tec-Dara outperformed DPd/DVd in terms of the trial’s secondary efficacy endpoints as well as quality of life outcomes and had a safety profile comparable to the control arm. Patients receiving Tec-Dara were significantly more likely to achieve a complete response or better, which occurred in 81.8% of patients receiving Tec-Dara and 32.1% among the control arm. They were also more likely to test negative for minimal residual disease (MRD), a sensitive test for remaining cancer cells, with 58.4% of those in the Tec-Dara arm achieving MRD-negativity compared with 17.1% in the control arm. Overall survival was also higher in the Tec-Dara arm, with 83.3% of patients in this group being alive at 36 months compared with 65.0% in the control arm.

The results showed comparable rates of treatment-emergent adverse events, with 95.1% of patients in the Tec-Dara arm and 96.6% of those in the control arm experiencing grade 3-4 adverse events. Rates of serious adverse events and discontinuations due to adverse events were also comparable between groups, researchers reported.

The rate of infections was higher among those receiving Tec-Dara, with 96.5% of patients in this group experiencing infections compared with 84.1% in the control group. The onset of higher-grade infections decreased over time, and researchers noted that strategies for managing infections also improved over the course of the study. Low-grade cytokine release syndrome (CRS) was also common, with grade 1-2 CRS occurring in 60.1% of those receiving Tec-Dara.

One limitation of the study is that patients refractory to daratumumab were not included in the trial. However, some patients (5%) had received daratumumab as part of their first-line therapy and benefited equally from the Tec-Dara combination.

Dr. Mateos noted that future studies could help clarify how doctors might select which patients would benefit most from the Tec-Dara combination in comparison to other therapies. Trials involving other bispecific antibody combinations are also underway and could shed additional light on the optimal use of such combinations as early as the first relapse.

Source: American Society of Hematology

Why are Men More Likely to Develop Multiple Myeloma than Women?

Study identifies several clinical features involved.

Photo by Daniil Onischenko on Unsplash

Rates of multiple myeloma (MM), the second most common blood cancer in the United States, are increasing and are twice as high in men than in women. A new study published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society, provides insights that may help to explain this disparity.

To investigate the sex difference in MM, researchers analyzed data on 850 patients with newly diagnosed MM enrolled in the Integrative Molecular And Genetic Epidemiology (IMAGE) study at the University of Alabama at Birmingham.

Compared with female patients, male patients were more likely to have advanced (International Staging System stage III) disease at the time of diagnosis. Males were also more likely to have high myeloma load—serum monoclonal protein (an abnormal protein produced by cancerous blood cells), more organ failure (especially kidney failure), and bone damage. Men were less likely than women to have low bone mineral density, and myeloma-defining features tended to differ between the two sexes. These differences were apparent even after taking numerous factors into account – including race, age, body mass index, education, income, smoking, and alcohol use.

Analyses suggested that certain chromosomal abnormalities that lead to initiation of myeloma occurring more often in younger males may help to explain some of the differences seen in this study.

“This research suggests that sex-specific mechanisms promote multiple myeloma pathogenesis, which may account for the excess risk seen in men,” said lead author Krystle L. Ong, PhD, of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham. “These findings may be used to improve risk stratification, diagnosis, and tailored treatments for both men and women with newly diagnosed multiple myeloma or related early precursor conditions.”

Source: Wiley

‘Wondrous’ Drug to Treat Aggressive Leukaemia Gets UK Approval

Killer T cells surround a cancer cell. Credit: Alex Ritter, Jennifer Lippincott Schwartz and Gillian Griffiths, National Institutes of Health (CC BY 2.0).

Adult patients with an aggressive form of leukaemia will be able to receive a breakthrough immunotherapy, which was invented by University College London researchers, on the NHS within weeks following approval for use by the UK’s National Institute for Health and Care Excellence (NICE).

The CAR T-cell therapy – known as ‘obe-cel’ and marketed as Aucatzyl – involves taking a patient’s immune cells and reprogramming them in a lab to identify and target their cancer, before returning them to the body as ‘living medicine’.

Obe-cel is a second-generation CAR T cell therapy invented by scientists from the UCL Cancer Institute, led by Dr Martin Pule, and has delivered promising results in treating patients with acute lymphoblastic leukaemia (ALL), an aggressive blood cancer.

The therapy has reduced immune toxicity and persists for longer in blood cancer patients, overcoming two common limitations of earlier CAR T cell therapies. Aucatzyl was taken through clinical trials and is manufactured by UCL spinout business Autolus, which was set up with the help of UCL Business, the commercialisation company of UCL.

The development of CAR T cell therapy has had long-standing support from the National Institute for Health and Care Research (NIHR) UCLH Biomedical Research Centre (BRC).

NHS England today announced that the personalised therapy would be available on the NHS within weeks through specialist centres.

Dr Claire Roddie, one of the team who developed the treatment from UCL Cancer Institute and UCLH consultant haematologist, said: “I am delighted to hear of NICE’s decision. Many more patients now stand to benefit from CAR-T cell therapy on the NHS. 

“We have been working on proving the safety and efficacy of this drug since 2017 and it has brought together clinical and research teams from UCL and UCLH, with support from government and arm’s-length bodies like the NIHR and the BRC as well as the pharmaceutical industry.

“The many, many people involved in this work can feel immensely proud of this achievement which will help save the lives of many more patients.”

Eligible patients will receive two doses of CAR-T therapy intravenously, ten days apart, with the treatment being delivered at specialist CAR-T centres across the country.

The treatment will be available to people aged 26 and over with B-cell acute lymphoblastic leukaemia which has returned or not responded to previous treatment. 

It is estimated that it could be administered to around 50 patients each year in England.

In a clinical trial, 77% of patients saw their cancer enter remission after treatment with obe-cel, with half of those showing no signs of detectable cancer after three and a half years. 

The treatment – which has been researched, developed and manufactured in the UK – was also found to have lower toxicity and was less likely to cause serious side effects than other CAR (chimeric antigen receptor) T-cell therapies.

Dr Anne Lane, UCL Business CEO, said: “This cutting-edge personalised immunotherapy has been on a 10-year journey starting with research by clinical academics in UCL’s Cancer Institute who, with the support of UCL Business, established Autolus, a spinout company dedicated to developing, trialling and bringing AUCATZYL® to market. That journey has required vision, tenacity and over £800m. Today that has hugely paid off and will benefit people across the UK. It’s an inspiring demonstration of what can be achieved when university academics, NHS hospitals and investors work together.”

Professor Peter Johnson, NHS National Clinical Director for Cancer, said: “This cutting-edge therapy has shown real promise in trials and could give patients with this aggressive form of leukaemia a chance to live free from cancer for longer – and, for some, it could offer the hope of a cure.

“This ‘living medicine’ boosts a patient’s own immune system and then guides T-cells towards the cancer to kill it – it is fantastic to have another pioneering option available on the NHS, adding to our range of CAR-T therapies which are helping people with blood cancers live longer, healthier lives.”

Harry, a 19-year-old student from Harrogate, was treated with obe-cel for B-cell ALL as part of a clinical trial in 2024. He said: “I feel so lucky to have had access to such a wondrous treatment. Not only did it work better than my doctors thought it would, it worked without many of the horrible side effects you can get from other treatments.

“I think it’s brilliant obe-cel is now available on the NHS for people over the age of 26. The biggest thing it offers is hope. When you’re facing a situation like mine, hope is the most valuable thing you can have.”

Health Minister Ashley Dalton said: “This pioneering treatment is excellent news for patients and their families, demonstrating how the NHS is at the forefront of medical innovation.

“Our 10 Year Health Plan is about harnessing our world-leading life sciences sector to deliver treatments like this – innovative therapies that save lives.

“By supporting new treatments with fewer side effects and shorter hospital stays, we’re building an NHS fit for the future whilst cementing the UK’s position as a global leader in medical research.”

Fiona Bride, interim Chief Commercial Officer and Director of Medicines Value & Access at NHS England, said: “This is a success story that’s made in Britain, and shows how collaboratively we can bring to life the ambition of the 10 Year Health Plan, showcasing how the UK’s competitive edge in life sciences can translate to better outcomes and treatments for NHS patients.

“The journey of obe-cel from scientific research in a UK university to a safe, clinically and cost-effective treatment set to be delivered through the NHS specialist CAR-T network is a remarkable one and I am grateful to colleagues who have played their part along the way.”  

Acute lymphoblastic leukaemia is an aggressive cancer in the blood and bone marrow, with around 800 people being diagnosed in the UK every year, around half of which are in adults.

Data shows patients with aggressive forms of the cancer receiving chemotherapy, the current routine standard of care, live for just 10 months on average after treatment.

The therapy will be fast tracked to patients more quickly than the standard 90-day implementation period thanks to interim funding from the NHS’s Cancer Drugs Fund.

Source: University College London

Diagnostic Breast MRI may be Unnecessary for Some Patients with Early-stage Breast Cancer

Adding breast magnetic resonance imaging (MRI) to a diagnostic mammogram did not reduce five-year cancer recurrence rates for patients with stage I/II hormone receptor (HR)-negative breast cancer, according to researchers at The University of Texas MD Anderson Cancer Center. 

The Phase III Alliance A011104/ACRIN6694 trial found that five-year locoregional recurrence rates were 6.8% in patients who received an MRI as part of a diagnostic work-up and 4.3% in those who did not. These data were presented today at the San Antonio Breast Cancer Symposium (SABCS) by principal investigator Isabelle Bedrosian, MD, professor of Breast Surgical Oncology (Abstract GS2-07).

“We have long assumed that finding more breast cancer on an MRI and removing it with surgery would help lower the chance of a patient’s cancer coming back,” Bedrosian said. “When you look at our findings alongside earlier trials, the message is clear: adding MRI before surgery doesn’t improve results for patients – and may not have to be used as a standard part of the diagnostic process.”

No additional MRI benefit in this group

The trial enrolled 319 patients between 2014 and 2018 with newly diagnosed stage I or II HR-negative breast cancer. These patients were eligible for lumpectomy and did not have germline BRCA1/2 mutations, bilateral breast cancer or a history of prior breast cancer. All patients had undergone diagnostic mammography with or without ultrasound prior to trial enrolment.  Patients were randomly assigned to undergo additional imaging by breast MRI (161 patients) or to receive no further imaging (158 patients).

Not only did breast MRI not impact five-year recurrence rates, but there were also not significant differences between groups for five-year distant recurrence-free survival nor overall survival. 

A small subset of patients with tumour subtypes (HR- HER2+ and HR-HER2-) and those over the age of 50 at diagnosis also showed no benefit to MRI.

Pre-op MRI not finding anything important

Breast MRI is a common part of the diagnostic evaluation because it can reveal cancer that mammography might not detect. However, the evidence that it improves surgical outcomes for patients has been limited.

“We believe the reason MRI did not reduce recurrence rates may be twofold,” Bedrosian said. “It is possible that MRI didn’t uncover many lesions that mammography hadn’t already found, or perhaps identifying and surgically removing those additional lesions was not important to reducing risk of the cancer coming back. It’s possible that in the group that did not receive MRI, radiation and chemotherapy effectively treated the occult areas of disease”. 

Experts are now analysing how often breast MRI identified additional lesions in the trial population to better understand why breast MRI did not impact oncologic outcomes.

Study limitations 

Limitations included that most patients involved in the trial had breast cancer that hadn’t spread to their lymph nodes, which may partly explain why recurrence rates were low overall. Despite being open to women of all ages, the study enrolled mostly older women who may have been less likely to benefit from breast MRI. 

SA Has Relatively High Anal Cancer Rates, but We Rarely Screen for It

People living with HIV are at an increased risk of developing anal cancer, particularly if they have compromised immune systems. Photo by Lorenzo Turroni on Unsplash

By Elna Schütz

South Africa has the world’s largest population of people living with HIV, which both heightens the risk of anal cancers and their severity. However, neither the collection of data nor the efforts for prevention and screening are in line with the likely impact. Experts say significant change is needed.

“Almost everyone has an anus,” Dr Daniel Surridge, a colorectal surgeon at Joburg Colorectal, says with a smile. He is one of a group of specialists trying to draw attention to arguably one of the most neglected areas in cancer.

“We’re quite a weird niche group who talk about bums all day, but most people are really in denial that they have an anus,” jokes Dr Tim Forgan, another colorectal surgeon, working in the private and public sector in Cape Town.

“It’s such an essential part of your daily life and you need your anus,” adds Dr Mark Faesen, specialist gynaecologist with the Clinical HIV Research Unit (CHRU), who runs an anal cancer screening clinic at Helen Joseph Hospital in Johannesburg, as far as we know, the only one in the country.

The stigma surrounding this particular body part, unfortunately, does no one any favours when it comes to cancer awareness and treatment.

A tricky hidden cancer

Anal cancers occur in the last few centimetres towards the external opening of the rectum. They can be associated with rectal, colon, or genital issues.

Professor Michael Herbst, health specialist consultant for the Cancer Association of South Africa, explains that the vast majority of these cancers are anal squamous cell carcinomas, meaning they develop in the skin cells of the anal canal.

Most anal cancers are caused by Human Papillomavirus (HPV), a virus that also causes most cases of cervical cancer.

“Patients and doctors often misdiagnose those early symptoms as haemorrhoids,” Herbst says, explaining that the disease is asymptomatic at first. Later, it may present with itching, discharge, bleeding or a palpable lump.

Ideally, a diagnosis is made of a pre-malignant lesion, which is a fairly flat, slightly dark growth. This can be found through a rectal exam or smear. A biopsy under anaesthesia may be needed to confirm the diagnosis.

Premalignant lesions can be treated topically if caught early. Otherwise, the skin may have to be surgically removed, which is often a difficult and risky surgery in this part of the body.

Once a lesion has progressed to cancer, treatment involves high doses of chemotherapy and radiation, which Surridge says is intense and only treats about half of patients effectively. “The rest go to a surgery where you have to remove the anus along with the rectum and put in a permanent colostomy bag,” he says.

In comparison to the rectal and colon cancers that Surridge sees in his work, he describes anal cancers as less predictable and more aggressive, with painful consequences. “It’s going to hurt like hell,” he says. “It stinks like you’re rotting from the inside, so no one wants to come near you.”

Anal cancers are also particularly resistant to chemotherapy, Surridge says, and run the risk of spreading through the lymph system, leading to a dismal outcome, possibly leading to death.

People living with HIV are at an increased risk of developing anal cancer, especially if they have compromised immune systems.

Faesen says that internationally, in the general population, the incidence of anal cancer is around 2 per 100 000 people per year. “If you’re HIV positive long enough, so over the age of 45, the risk is 20 to 40 per 100 000 per year,” he says. For men who have sex with men, the incidence can be as high as 60 or 130 per 100 000.

Those with HPV and patients with immune systems not working as well as they should, such as those who have received an organ transplant, are at risk. Furthermore, groups who engage in high-risk sexual activities, like men who have anal sex with multiple male partners, should be aware of the risk. However, sexual orientation and anal sex do not directly lead to an increase in anal cancer risk.

Rare but not that rare

Anal cancer may be considered a rare cancer, but the few local experts on it see it as a concerning cancer because of South Africa’s high number of people who are at increased risk.

“Anal cancer is strangely common in South Africa. It’s not extremely common, but it is reasonably common,” says Forgan.

The National Cancer Registry’s latest numbers, from 2023, has the cancer reported in around 300 women and 220 men, making up less than 0,7% of reported cancers. A recent analysis of the registry’s numbers found that the cancer’s incidence has significantly increased between 1994 and 2021. The paper found that younger black women and older white women were most likely to get the cancer. A study at the University of the Witwatersrand in 2023 found that three-quarters of their anal cancer cohort were female and 80% were HIV positive.

“We don’t actually know the true incidence in South Africa,” says Dr James Pattinson, Head of Colorectal Surgery at Chris Hani Baragwanath Academic Hospital, explaining that the disease is likely under-reported. Anecdotally, he says the cancer seems common in Gauteng. He says his unit alone sees around 100 new cases of anal cancer a year, making up around 30% of new reported colorectal cancers.

Surridge says it is getting more common, and “it is certainly raging through Gauteng”.

The challenges

The doctors agree that the reported numbers are likely lower than the real prevalence and that many cases could be avoided or caught early with intervention. A key factor is the lack of education and patient hesitancy to get tested. “The natural stigma and embarrassment associated with anal conditions cause patients to wait until the condition is severe before seeking medical help,” Pattinson says.

“The lack of awareness doesn’t stop at the door of the Department of Health,” Faesen says. He laments that few healthcare workers are well-informed about this cancer. This leads to misdiagnoses and problems being missed. This is aggravated by financial and resource constraints. But, he says, this is not a “blame game”, since the greater awareness of anal cancer is fairly new.

For instance, the International Anal Neoplasia Society’s consensus guidelines for anal cancer screening were only released in early 2024. Faesen explains that while cervical cancer screening was popularised internationally around the 1960s, it was only a study published in the New England Journal of Medicine in 2022 that found that treating lesions substantially lowers the risk of anal cancer, that heightened the interest in screening.

In that study, of over 4 000 people, progression to anal cancer was more than 50% lower in people who received treatment for precancerous lesions than in people who did not. The study provided a compelling rationale for increased screening, since it is only through finding precancerous lesions in the first place that they can be treated and progression to cancer be prevented.

Reaching the level of common-place awareness for anal screening that there is around cervical pap smears is still a while away. “It took 50 to 60 years to get there, but we’ve just started,” Faesen says. “We are at the absolute beginning of anal cancer awareness.” He does however note that the incidence of anal cancer in some South African populations is already much higher than that of cervical cancer when routine screening for that was started.

What to do

The lack of screening for anal cancer is one clear issue that needs to be addressed. “Hopefully, we can demonstrate with more and more screening that there is a need for it,” Faesen says. He hopes that this will catch the problem before it progresses to a serious disease in more patients.

However, Pattinson notes that screening in other countries has been historically focused on high-risk populations such as men who have sex with men. “This is obviously not feasible in South Africa, as high-risk individuals are the millions of people living with HIV.”

Screening could potentially be focused on certain sites, like HIV-specific clinics or doctors who particularly work with HPV and cervical screening. Expanding screenings for high-risk groups to include anal would not be incredibly expensive but would add an extra burden on staff, Forgan says. “And it’s a very easy thing to screen for. You just have a look.”

There is also a preventative solution, the HPV vaccine. A two-strain form of this vaccine is already offered to girls aged 9 to 12 years old by the Department of Health. This does not cover other strains and is mostly focused on cervical cancer.

Surridge says that focusing on vaccinating only girls means boys aren’t protected, and creates a possible lag in protection against anal cancer. He says the vaccine, ideally one with more strains, if possible, should be given to as many people as possible.

“If you’re in a higher risk group, like those (who are) immuno-suppressed, with HIV, or solid organ transplant recipients, you should be vaccinated,” Forgan says. “Then you wouldn’t need a screening programme, per se, because you had prevented it from happening.”

Beyond this, increasing education around the disease and eventually instituting local guidelines would be crucial.

The National Department of Health did not respond to questions from Spotlight about their plans relating to anal cancer.

Republished from Spotlight under a Creative Commons licence.

Read the original article.

Targeted Radiation During Surgery Reduces Pancreatic Cancer Recurrence

Image of a what is targeted with radiation. Red represents the pancreatic tumor, which is contacting with a major nearby artery. Yellow represents the Baltimore Triangle, which is now targeted in all patients, in addition to red volume. Credit: Amol Narang, M.D.

Using targeted radiation during surgery – referred to as intraoperative radiation – to eliminate pancreatic cancer cells that have spread to areas around the pancreas, investigators at Johns Hopkins have been able to reduce the recurrence rate around the pancreas to 5%. This is believed to be the lowest ever reported for this population of patients, according to a preliminary study by the team from the Johns Hopkins Kimmel Cancer Center.

The study was presented at the American Society for Radiation Oncology annual meeting in September 2025.

The study enrolled 20 patients with borderline resectable or locally advanced pancreatic cancer. Patients received presurgical chemotherapy and radiation targeted to shrink the tumours away from the blood vessels. Then, during surgery to remove their tumours, patients received another dose of precisely targeted radiation using a robotic device that carries small radioactive beads inserted through catheters. The device enabled the team to pinpoint a triangular area near the pancreas, where recurrences commonly occur. Only one of the 20 patients experienced a recurrence around the pancreas at the 24-month mark – a major achievement for a cancer that, until recently, had lagged behind other cancers in treatment success.

By the time most pancreatic cancers are diagnosed, the tumours have spread to affect important blood vessels around the pancreas. Historically, patients with pancreatic cancers whose blood vessels were affected could not undergo surgical removal of their tumours. But in the past decade, clinicians at the Johns Hopkins Kimmel Cancer Center’s Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care have pioneered new approaches that use chemotherapy and radiation to shrink the tumours away from blood vessels, enabling more patients to undergo surgical removal of their tumours.

However, many of these patients continued to experience tumor recurrences, and Amol Narang, M.D., associate professor of radiation oncology and molecular radiation sciences, and his colleagues sought to determine why.

The team learned that the pancreatic cancer cells were spreading along nerves near the pancreas to a fatty, nerve-dense triangular area just above the pancreas, which Narang calls the “Baltimore triangle.” When he and his colleagues started targeting the Baltimore triangle with radiation before surgery to kill these stray cancer cells, pancreatic cancer recurrence rates in their patients dropped from 47% to 12% at two years post-surgery. Yet, in the 12% who experienced recurrences around the pancreas, the recurrences continued to occur in the Baltimore triangle.

To further lower recurrence rates, Narang and his colleagues decided to deliver an additional round of Baltimore triangle-targeted radiation to patients during surgery after removal of the pancreatic tumour. He explained that, during the surgery, surgeons remove a part of the duodenum, next to the pancreas, making it easier to access the Baltimore triangle without risking harm to surrounding organs. The combination of radiation targeted to the Baltimore Triangle prior to surgery as well as intraoperative radiation to the triangle during surgery allowed Narang to deliver ablative doses of radiation to this region.

“The combination of intraoperative radiation and targeting the Baltimore triangle has gotten us to a 5% recurrence rate, which is the lowest-ever reported recurrence rate around the pancreas for this population of patients to our knowledge. But I think we can drop to 0% in our next study,” Narang says. “We must do whatever we can to prevent recurrences from happening, because when pancreatic cancer comes back, it is often incurable. These results give us hope, though, that this can be done for a cancer where even decade ago, most thought this wasn’t possible.”

The only recurrence in the study occurred in the part of the Baltimore triangle that the team had difficulty reaching during the intraoperative treatment. Currently, the team is developing strategies to target this hard-to-reach part of the triangle, with the hopes of reducing recurrences to zero. Once they’ve mastered that refined approach, they would like to team up with other cancer centres across the US to run a larger clinical trial to confirm their results. 

Source: Johns Hopkins Medicine