Outcomes4Me Secures $21M in Funding Learn more >>

First major bladder cancer treatment breakthrough in 25 years

April 23, 2026

DNA test sequence for research and science

There’s encouraging news for people diagnosed with muscle-invasive bladder cancer (MIBC). New research presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium showed that a combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) may help patients live longer and reduce the risk of the cancer returning, which is outperforming the current standard chemotherapy approach.

For patients who are eligible for cisplatin-based chemotherapy and radical cystectomy (bladder removal surgery), this could represent a major step forward in treatment.

What did the study look at?

Researchers studied 808 patients with localized MIBC. These patients were randomly assigned to receive one of two treatment approaches before surgery:

  • Enfortumab vedotin + pembrolizumab (EV+P)
  • Cisplatin + gemcitabine (the current standard chemotherapy combination)

Both groups received 4 cycles of treatment before surgery. After surgery:

  • Patients in the EV+P group continued treatment with the combination therapy.
  • Patients in the cisplatin + gemcitabine group were monitored without additional treatment.

The goal was to see which treatment was better at delaying recurrence, preventing progression, and improving survival.

The results were significant

Patients who received EV+P had better outcomes across several important measures compared with those who received chemotherapy.

Longer event-free survival

One of the most important findings was improved event-free survival, meaning patients went longer without the cancer coming back, progressing, or causing serious complications.

At 24 months, the event-free survival rates were:

  • 79.4% for patients receiving EV+P
  • 66.2% for patients receiving cisplatin + gemcitabine

This means patients receiving the newer combination were significantly more likely to remain free of disease-related events two years after treatment.

Improved overall survival

The study also found that overall survival was higher in the EV + P group.

At 24 months, overall survival rates were:

  • 86.9% with EV+P
  • 81.3% with cisplatin + gemcitabine

While the difference may seem modest, improvements in overall survival are especially meaningful in MIBC, where recurrence risk can be high.

Higher rates of complete response

Another exciting finding was the pathological complete response rate, which measures how many patients had no evidence of cancer left in the bladder tissue after treatment and surgery.

The complete response rates were:

  • 55.8% with EV+P
  • 32.5% with cisplatin + gemcitabine

Among patients who underwent surgery, the response rates were even higher:

  • 64.4% with EV+P
  • 36.3% with cisplatin + gemcitabine

This suggests the newer combination may be much more effective at eliminating cancer before surgery.

Why this is such an important milestone

For nearly 25 years, cisplatin-based chemotherapy has been the standard treatment before surgery for MIBC.

That is a major breakthrough. It means that this combination therapy may offer patients a better chance of avoiding recurrence and improving long-term survival.

Understanding the side effects

As with any cancer treatment, side effects are an important part of the conversation.

Patients receiving EV + P  were more likely to experience:

  • Itching
  • Diarrhea
  • Hair loss
  • Rash
  • Peripheral neuropathy
  • Skin reactions

Patients receiving cisplatin + gemcitabine more often experienced:

  • Low white blood cell counts
  • Low platelets
  • Anemia
  • Nausea

Surgical side effects were similar between both groups, meaning the new treatment didn’t appear to make surgery riskier.

What this means for patients

These findings could change how MIBC is treated. Medical oncologist Dr. Elizabeth Plimack explains that EV+P has “really dramatic effects on clearing the bladder of MIBC,” and many centers are now using this approach, especially in clinical trials. “This is a rapidly changing field, and it’s important for patients to talk with their medical oncologist about the newest treatments and clinical trials that could be right for them,” she adds.

To learn more about the latest treatment options in bladder cancer care, watch the full webinar discussion with Dr. Elizabeth Plimack.

More Articles