IN Europe, immunotherapy can also be used for early forms of bladder cancer, and not just for metastatic ones. The European Commission has in fact given the green light for the use of the drug nivolumab for adult patients with muscle-invasive urothelial carcinoma at high risk of relapse after complete removal. “Although early diagnosis allowed for surgical removal of the tumor, about half of patients with muscle-invasive urothelial carcinoma relapse due to the few effective and safe treatment options that can prevent relapses,” he said. Fred Witjes, professor of urology oncology at the Radboud Institute for Molecular Life Sciences: “With the approval of nivolumab, doctors now have an immunotherapy option to offer. This decision will potentially revolutionize the treatment of muscle-invasive urothelial carcinoma of a specific type of patient in the European Union ”.
I study
The decision is based on results from the CheckMate -274 study (published in the New England Journal of Medicine as of June 2021), in which nivolumab demonstrated a statistically significant and clinically relevant improvement in disease-free survival compared to placebo. In particular, data were considered regarding patients whose tumors exhibited marker PD-L1 expression (≥1%), which showed a 47% reduction in the risk of relapse or death with nivolumab compared to placebo. Median disease-free survival was not reached in patients treated with immunotherapy, while it was 8.41 months in the comparator arm.
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Urothelial carcinoma and the impact on quality of life
Urothelial carcinoma accounts for approximately 90% of bladder cancer cases and is the 10th most common cancer in the world. It can also occur in other parts of the urinary tract, such as the ureters and renal pelvis. Most urothelial cancers are diagnosed early, but the rates of disease recurrence and progression are high. In patients whose recurrence presents as metastatic cancer, the prognosis is poor, and overall survival is approximately 12-14 months. “In addition to the physical and psychological impact of the surgery, patients must also manage the fear of the tumor returning”, recalled Alex Filicevas, executive director of the World Bladder Cancer Patient Coalition: “We are satisfied with the approval of a new treatment adjuvant which may reduce the risk of relapse. Undergoing surgical removal of the bladder due to muscle-invasive bladder cancer is a life-altering experience, which makes the published data even more important, namely that nivolumab has maintained quality of life compared to placebo ” .
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Immunotherapy for early cancers
Nivolumab is currently approved in the European Union for the adjuvant (post-surgical) treatment of three different types of cancers: melanoma, esophageal or gastroesophageal junction cancer, and now also urothelial cancer. “We are driven by the goal of advancing new treatment options that can help change the perspectives of cancer patients, with both early stage and metastatic disease,” said Dana Walker, MD, MSCE, vice president, head of Bristol Myers Squibb genitourinary cancer development program: “The approval of nivolumab gives us the opportunity to introduce a new standard of post-surgery care for certain patients with urothelial cancer, backed by experience as the first company to supply Immune checkpoint for European Union patients in the adjuvant setting of melanoma and esophageal tumors. We want to collaborate with European stakeholders – he concludes – to make nivolumab available as soon as possible for eligible patients “.