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Immunotherapy May Boost Bladder Cancer Survival

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From the WebMD Archives

Is maintenance therapy with an immunotherapy drug a good idea for patients with advanced bladder cancer whose cancer doesn’t get worse – or progress -- after initial chemotherapy?

Yes, and furthermore this approach offers "a new first-line standard of care for advanced urothelial cancer," said Thomas Powles, MD, professor of genitourinary oncology and director of the Barts Cancer Centre in London, UK.

Powles was discussing "first-line maintenance therapy" with avelumab (Bavencio) from a clinical trial called the JAVELIN Bladder 100 Trial.

Results from this trial were presented at the 2020 annual meeting of the American Society of Clinical Oncology, held virtually because the coronavirus pandemic. ASCO chief medical officer Richard Schilsky, MD, PhD, highlighted the results as "practice-changing."

The trial involved 700 patients whose cancer had not progressed after at least four cycles of chemotherapy. Maintenance therapy with avelumab improved overall survival by 7.1 months when compared with supportive care alone.

The median overall survival was 21.4 months for avelumab plus supportive care vs 14.3 months for supportive care alone.

An expert not involved with the study was impressed with the outcome.

"The data are encouraging and we look forward to FDA review, and hopefully approval [in this setting]," said Padmanee Sharma, MD, PhD, a genitourinary medical oncologist at the University of Texas MD Anderson Cancer Center in Houston.

Avelumab, like a number of other immune checkpoint inhibitors, is already approved for use in advanced bladder cancer as a second-line treatment when chemotherapy doesn’t work.

"Instead of Waiting for Cancer to Return"

Powles said that about 65% to 75% of patients with advanced bladder cancer have disease control with first-line chemotherapy, but that progression-free survival and overall survival are "short" because the cancer becomes resistant to the chemotherapy.

Many patients do not receive second-line treatment with immunotherapy and only a "minority" achieve benefit, he added.

"Instead of waiting for the cancer to return," which it will do "quickly," Powles suggested that maintenance with immunotherapy should become the standard of care.

"Our findings should give hope to many patients with advanced urothelial cancer who face a very challenging and difficult condition," coauthor Petros Grivas, MD, PhD, clinical director of the Genitourinary Cancers Program at the Seattle Cancer Care Alliance (SCCA), said in a statement.

"People with advanced urothelial cancer generally have a poor prognosis, and most experience cancer progression (growth) within 8 months after initiation of first-line chemotherapy," he said.

"We are very excited with these results, which indicate that immunotherapy with avelumab first-line maintenance could offer a new treatment option that helps patients live longer. Even if this is likely not a complete cure and may cause potential side effects in some patients, the significant prolongation of overall survival is clearly a remarkable improvement, while many treated patients may not experience significant side effects from this approach," he said.

The most frequent side effects were urinary tract infection, anemia, blood in urine, fatigue, and back pain.

Sharma said she would like to see more detailed data related to the number of chemotherapy cycles administered (the range was 4 to 6) and information on the amount of time between the end of chemo to the start of avelumab. Powles said that his international team has not looked at number of cycles and outcome, nor the time from completion of chemotherapy and randomization. "They are both valid questions for the future," he said.

The study was funded by Pfizer. Powles and many of the coauthors have financial relationships with Pfizer and other pharmaceuticals. Sharma has disclosed no relevant financial relationships.

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