New York, NY (May 14, 2020) - A clinical trial led by Mount Sinai researchers has showed for the first time that combining chemotherapy and immunotherapy can slow down metastatic bladder cancer. The trial also showed that immunotherapy alone may be an option for a subset of patients with metastatic bladder cancer if their tumor expresses a high level of a protein called PD-L1 according to the study, published in The Lancet in May.
This randomized, Phase 3 clinical trial, named IMvigor130, measured 1,213 patients' response to chemotherapy--either gemcitabine plus cisplatin or gemcitabine plus carboplatin--and the immunotherapy drug atezolizumab versus chemotherapy alone or atezolizumab alone.
"This is the first study to show that combining chemotherapy and immunotherapy significantly delays progression of metastatic bladder cancer compared with chemotherapy alone, and the first randomized study to contextualize the use of immunotherapy alone as a first-line treatment option for patients with metastatic bladder cancer based on expression of the PD-L1 protein," said lead author Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and Professor of Medicine at the Icahn School of Medicine at Mount Sinai.
The trial data has already changed whether doctors use immunotherapy or chemotherapy alone for a subset of patients by screening patients to see the level of PD-L1 present in their tumors. The trial may support using the combination of chemotherapy with immunotherapy as a standard treatment for metastatic bladder cancer once final results are available.
This trial was sponsored by F. Hoffmann-La Roche and Genentech.
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Link to journal article when embargo lifts: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736