What the trial was testing
The EV-301 enrolled 608 patients with bladder cancer. The study was sponsored by Astellas Pharma Global Development, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People receiving enfortumab vedotin lived a median of 12.9 months compared to 9 months with chemotherapy.
The New England journal of medicine · 2021 · NCT03474107
These findings — that people lived nearly 4 months longer than those on standard chemotherapy — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 608 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with bladder cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Enfortumab vedotin is FDA-approved for advanced bladder cancer that has gotten worse after other treatments. If you've already tried platinum-based chemotherapy and immunotherapy, ask your doctor whether this treatment might be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open bladder cancer trials
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.
HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC