Doctors are hailing a new combination of treatments that spares patients with aggressive bladder cancer the need for life-changing surgery to remove their entire bladder, while dramatically reducing the risk of the disease returning.
Bladder cancer is the ninth most common cancer in the world, with approximately 614,298 new cases diagnosed globally in 2022 – a 7.1% increase from 2020. In the UK alone, nearly 11,000 cases are diagnosed each year. Men are disproportionately affected, accounting for more than three-quarters of both new cases and deaths worldwide. The standard treatment for advanced or aggressive forms has long been radical cystectomy, the surgical removal of the bladder, which leaves patients reliant on alternative methods to pass urine for the rest of their lives – often through a urostomy bag.
The artist Tracey Emin, diagnosed with an aggressive squamous cell carcinoma of the bladder in 2020, underwent extensive surgery that removed her bladder, urethra, lymph nodes, part of her intestine and half of her vagina. She has spoken openly about the challenges of living with a urostomy bag, describing it as “quite a disadvantage for lots of reasons” and something “most people would want to keep a secret”. Her experience underscores the profound physical and psychological burden that radical surgery imposes.
Now, a phase-two trial led by the Institute of Cancer Research (ICR) in London has shown that adding the immunotherapy drug durvalumab to a regimen of chemotherapy and radiotherapy can spare patients that operation while keeping the cancer at bay. Results presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago found that cancer did not return in 46 out of 54 patients – or 85% – after one year. By contrast, previous trials using chemotherapy and radiotherapy alone prevented recurrence in only 60% of patients.
The key to this breakthrough lies in how durvalumab works. The drug is a PD-L1 inhibitor, a type of immunotherapy that blocks a protein cancer cells use to hide from the immune system. Normally, PD-L1 on the surface of tumour cells binds to PD-1 receptors on immune T-cells, effectively turning off the body’s natural attack. Durvalumab latches onto the PD-L1 protein, preventing that disguise and “switching on” the immune system so it can recognise, target and destroy the cancer. In this trial, durvalumab was administered alongside chemoradiotherapy, a combination that appears to amplify the immune response and eliminate tumours more effectively than either approach alone.
The RAD-IO trial, funded by AstraZeneca and the University of Birmingham, enrolled patients with muscle-invasive bladder cancer (MIBC) – a stage where the tumour has penetrated the bladder wall and risk of spread is high. The primary aim was to see whether the addition of immunotherapy could allow patients to avoid radical cystectomy. Preliminary safety data from the same trial, also presented at ASCO, indicated that the combination was feasible and tolerable, with side effects consistent with the known profiles of each drug. The efficacy results met pre-set criteria for further evaluation, showing “very high” bladder preservation and survival rates compared with historical controls.
Professor Nick James, professor of prostate and bladder cancer research at the ICR, said: “In 2012, my team showed that adding a low-cost chemotherapy drug to radiation provides good long-term benefit to bladder cancer patients. Now, we’ve shown that with the addition of immunotherapy, the combination of treatments has an even bigger improvement in outcomes – fewer cancers come back. Importantly, we’ve shown that it’s possible to achieve these outcomes without surgically removing the bladder. Keeping the bladder means people can avoid major, life-changing surgery and maintain more of their normal daily function and independence. I expect this approach to be practice-changing – offering bladder cancer patients improved outcomes whilst preserving their quality of life.”
Professor Kristian Helin, chief executive of the ICR, said the results represented “a significant step forward for people with aggressive bladder cancer”. He added: “By adding immunotherapy to chemotherapy and radiotherapy, we may be able to spare patients the physical and psychological burden of having their bladder removed entirely – and after one year, we’re already seeing a meaningful reduction in the risk of the cancer returning.”
Durvalumab – marketed as Imfinzi – has already been approved in other bladder cancer settings. The phase-three NIAGARA trial, which investigated durvalumab in combination with neoadjuvant chemotherapy (gemcitabine and cisplatin) followed by adjuvant durvalumab, showed a 25% reduction in the risk of death compared with chemotherapy alone, leading to FDA approval for that regimen as a new standard of care for muscle-invasive disease. Separately, the POTOMAC trial found that durvalumab combined with Bacillus Calmette-Guérin (BCG) reduced the risk of recurrence, progression or death by 32% in high-risk, non-muscle-invasive bladder cancer – earning FDA approval in May 2026 as the first new therapy for that patient group in more than three decades.
Michelle Mitchell, chief executive of Cancer Research UK, who was not involved in the study, said: “Radical surgery can cause serious side effects for bladder cancer patients. Finding kinder ways to treat the disease is incredibly important, and this trial has done exactly that. Further research will be needed at a larger scale to know for sure, but these results have the potential to be life-changing for some bladder cancer patients. Breakthroughs just like this are essential to ensure people affected by cancer can live not just longer lives, but better lives.”