New Drug Combination Outperforms Standard Chemotherapy for Bladder Cancer, Trial Finds

A major phase 3 trial published in the New England Journal of Medicine has found that combining enfortumab vedotin and pembrolizumab produces better outcomes than cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer.

The New England Journal of Medicine has posted results from the KEYNOTE-B15/EV-304 trial, a phase 3 study testing whether a newer two-drug combination could replace cisplatin-based chemotherapy — long the standard treatment — for patients with muscle-invasive bladder cancer (cancer that has grown into the muscle wall of the bladder). The trial compared enfortumab vedotin, an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, paired with pembrolizumab, an immunotherapy drug that helps the immune system attack tumours.

The NEJM also published an accompanying editorial asking directly whether these results mark “the end of the cisplatin era” in muscle-invasive bladder cancer — a question that reflects how seriously the oncology community is taking the findings.

Bladder cancer is one of the more common cancers in the UK. Muscle-invasive disease is the more serious form, where tumour cells have spread beyond the inner lining into the bladder wall, making it harder to treat and more likely to spread further.

Cisplatin-based chemotherapy has been the backbone of treatment for decades. But not every patient tolerates it well, and researchers have been searching for regimens that are both more effective and better tolerated.

The trial is described as phase 3, meaning it involved a large patient group in a controlled comparison — the standard required before findings can inform clinical guidelines. The results and editorial are available through the NEJM for clinicians and researchers.

For patients in Kent with concerns about bladder cancer symptoms — which can include blood in the urine, needing to urinate more often than usual, or pain when urinating — the NHS advises contacting your GP in the first instance. For urgent concerns, NHS 111 is available around the clock.

Key information

• Speak to your GP if you notice blood in your urine or changes in your bladder habits
• NHS 111 is available 24 hours a day for urgent health concerns that are not emergencies
• In an emergency, call 999