New Hope For Patients Battling Muscle-Invasive Bladder Cancer
- The nearly 200,000 Americans currently living with muscle-invasive bladder cancer (MIBC) may soon have better treatment options, thanks to new research presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium, a major medical meeting where cancer experts share the latest research and treatments.
- Data from the KEYNOTE-B15 clinical trial, presented at the symposium, show that combining Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) before and after surgery may better control cancer and help patients live longer.
- For patients, this means a stronger chance of shrinking tumors, lowering the risk of recurrence, and improving long-term survival.
- This new treatment approach could change how MIBC is cared for by giving patients a more effective and more personalized option — even for people who cannot receive the current standard chemotherapy approach with cisplatin. Cisplatin can damage the kidneys and hearing, so patients with kidney problems or hearing loss often cannot use it.
The data, shared at a major scientific meeting called the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, held in San Francisco in February 2026, point to what leading experts are calling the biggest advance in bladder cancer treatment in 20 years.
Read More- Shrink or eliminate tumors before surgery
- Reduce the risk that cancer comes back
- Improve long-term survival
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For nearly 25 years, most people with MICB have been treated with cisplatin-based chemotherapy before surgery. While this approach has helped some patients live longer, progress has been slow, and many patients have continued to face heightened risk of cancer recurrence.
“It hasn’t been that long since bladder cancer was almost an orphan disease, with cisplatin being the most important [therapy] in the entire modern history of bladder cancer,” Dr. Elizabeth Wulff, a medical oncologist at the University of Kansas Health System, tells SurvivorNet. “And the data that has come out of this trial is truly practice-changing because of its impact on disease-free survival.”
“Enfortumab vedotin and pembrolizumab has been a treatment available to patients with advanced bladder cancer for a few years,” Dr. Wulff explains. “Following [the trial] EV-302, it was shown to be a practice-changing treatment for advanced disease.”
A Move To Earlier-Stage Disease
What makes these data particularly compelling is the consistency of benefit across disease states. In metastatic disease, the combination improved survival.
Now, in earlier-stage muscle-invasive bladder cancer, it is showing the ability to both improve cancer control and extend survival.
“We’ve taken something that has improved survival as well as cancer control for patients with metastatic disease and now moved it into the curative intent setting with incredible success,” Dr. Wulff explains.
This change — from treatments that focus on comfort [palliative care] to treatments that aim to cure the disease — is an important turning point.
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Historically, many of the most effective systemic therapies in oncology were first developed for advanced disease, with gradual movement into earlier lines of treatment.
“The data most recently presented has shown that enfortumab vedotin and pembrolizumab reduces the risk of recurrence and improves overall survival,” Dr. Wulff added.
When asked if the new treatment could replace cisplatin, Dr. Wulff said the new findings are “immediately actionable and practice-changing.”
What Do These Updates Mean For Patients?
While many experts view the new data as practice-changing, not everyone is ready to immediately replace cisplatin-based chemotherapy.
In a separate interview with SurvivorNet, Dr. Sarah Psutka, a urologic oncologist at Fred Hutchinson Cancer Center, emphasizes the importance of interpreting these findings in the context of current clinical practice.
She notes that the trial compared Padcev plus Keytruda before surgery to neoadjuvant chemotherapy [chemo before surgery] alone — without additional cancer treatment.
“This was a study comparing treatment around the time of surgery,” she explains. “But in modern practice, many patients (particularly those with residual disease) are considered for additional therapy after surgery.”
However, only a few patients in the chemotherapy group received additional treatment afterward, which makes it unclear if this group represents the care patients usually get today.
At the same time, the investigational arm involved a more intensive approach, with treatment given both before surgery and for up to a year afterward. “This is a lot more therapy,” Dr. Psutka notes.
Another caveat, Dr. Psutka explains, is that cisplatin is not an option for many patients. Because bladder cancer predominantly affects older individuals, often with comorbidities, up to half of patients are ineligible for cisplatin due to kidney function, neuropathy [damage to nerves], or other factors.
The availability of Padcev plus Keytruda in both cisplatin-eligible and ineligible populations represents an important advance. However, Dr. Psutka cautions that further research is needed.
Redefining Care In Bladder Cancer
The phase III KEYNOTE-B15 trial tested a new drug combination, Padcev plus Keytruda, in people with muscle-invasive bladder cancer (MIBC) who were preparing for bladder surgery. The study compared this combination to the usual chemotherapy approach.
The results are very encouraging as patients who received Padcev and Keytruda were more likely to have their tumors completely disappear before surgery, and they lived longer without the cancer returning. Overall survival was also better, meaning fewer patients died compared with standard chemotherapy.
This is especially exciting because it’s the first time a treatment without traditional chemotherapy has shown better results than the standard approach before surgery for MIBC, offering new hope for patients facing this aggressive form of bladder cancer.
Understanding Bladder Cancer Treatment
Bladder cancer can be treated in various ways, but your doctor will consider several factors to determine the best treatment. Where the cancer is inside your body and if it has spread are some factors doctors look at before finalizing your treatment plan.
Surgery for bladder cancer often offers the best chance for a cure. There are various surgical options depending on the location of your bladder cancer.
For patients with non-muscle invasive bladder cancer, treatment will most likely consist of transurethral resection of visible bladder tumor (TURBT). During this procedure, the surgeon gently inserts a surgical instrument containing a camera into the urethra and pushes it upward until it reaches the bladder.
Once at the bladder, the instrument is used to remove all the tumors that the surgeon can see on camera. Most patients can leave the hospital on the same day, but some may need to stay longer, depending on the extent of tissue removal required.
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If the surgeon and pathologist determine that more tissue needs to be removed, additional surgery may be performed four to six weeks later.
Depending on the aggressiveness of your tumor, cystoscopy (a procedure to see inside the bladder and urethra) will be required to check the area once a year or as frequently as every few months for the first few years after treatment. This is combined with routine imaging of the urinary tract.
Chemotherapy is usually recommended before cystectomy, or the total or partial removal of the bladder. Giving chemotherapy prior, or “neoadjuvant,” has been shown in large trials to improve survival in bladder cancer.
Other options to treat bladder cancer may include immunotherapy or targeted therapy.
Dr. Arjun Balar on immunotherapy for bladder cancer
Questions To Ask Your Doctor
- Am I a candidate for the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) treatment approach?
- What are the risks vs. benefits of enfortumab vedotin and pembrolizumab?
- What side effects should I be aware of?
- What can we do if side effects become too severe?
Contributing: SurvivorNet Staff
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