by Ernie Mundell

A cancer drug duo more than doubled the survival of people battling the most common form of advanced bladder cancer, trial results show.

Patients who took a combo of meds called EV+P—enfortumab vedotin and pembrolizumab (Keytruda)—had an average of 31.5 months survival, compared to just over 16 months for those on standard chemotherapy, researchers reported March 7 in the New England Journal of Medicine.

"This is revolutionary for patients," said study co-investigator Dr. Jean Hoffman-Censits. She directs the Upper Tract Urothelial Cancer Multidisciplinary Clinic at the Johns Hopkins Greenberg Bladder Cancer Institute in Baltimore.

"It's a practice-changing study, where we're nearly doubling the overall survival for patients with locally advanced and metastatic urothelial cancer," she said in a Hopkins news release.

Urothelial tumors are the most common form of bladder cancer. According to the American Cancer Society, more than 83,000 new cases of bladder cancer are diagnosed each year and the illness kills almost 17,000 people annually.

The new trial was funded by drug maker Astellas Pharma US. It involved 886 patients with advanced urothelial cancers enrolled from cancer centers in 25 countries. Patients averaged 69 years of age and about three-quarters were men (bladder cancer is much more common in men).

During three-week cycles, patients received either the intravenous EV+P regimen or standard chemotherapy (gemcitabine and either cisplatin or carboplatin). Treatment lasted 17 months.

Besides the doubling of overall survival times, there was also a near-doubling of "progression-free survival"—the amount of time a patient lives without his or her cancer progressing. Patients on EV+P had a progression-free survival averaging 12.5 months, compared to 6.3 months for people on standard chemo.

Onerous side effects occurred less frequent among folks getting EV+P, as well: About 60% of people receiving the newer combo had side effects, compared to just under 70% of those on the older regimen.

While Keytruda has long been FDA-approved to fight a myriad of cancers, enfortumab vedotin (Padcev) only received agency approval for use in urothelial cancers in December.

The drug is an "an antibody-drug conjugate," where an anticancer drug is attached to a monoclonal antibody, which then seeks and destroys tumor cells.

Speaking in a Hopkins news release, Hoffman-Censits said "we're also expanding the patient population who can get treated with this very active therapy because many are not candidates for or could not tolerate the prior standard chemotherapy, which can be incredibly toxic."

More information: Find out more about bladder cancer at the National Cancer Institute.

Thomas Powles et al, Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer, New England Journal of Medicine (2024). DOI: 10.1056/NEJMoa2312117

Journal information: New England Journal of Medicine 

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