Immunotherapy shown to be effective against metastatic bladder cancer

  • Clinical research carried out as a phase I study shows that immunotherapy is safe and effective in reducing the size of bladder cancer metastases, leading to future phase II and III clinical trials.
  • 43% of patients with a metastatic bladder tumor positive for the PD-L1 biomarker responded to treatment and metastases were reduced.

Barcelona, November 27, 2014. A multicenter study*, in which the Vall d’Hebron Institute of Oncology (VHIO) was the only research institute from Spain to participate, reports promising results of a phase I clinical trial using immunotherapy to treat metastatic bladder cancer. Cristina Cruz, oncologist and clinical researcher of VHIO’s Early Clinical Drug Development Group participated in this study, published today in the scientific journal Nature. Results show that immunotherapy effectively reduces the size of metastatic bladder tumors, for which there are few therapeutic options available and with limited efficacy. These latest findings therefore represent a source of hope for this tumor type with a typically poor prognosis.

Bladder tumors are more common in men than women, with an incidence of 39 cases per 100,000 population, ranking as the tumor type with the fourth-highest incidence in men and the fifth-highest incidence in the general population. Bladder tumors are closely linked to tobacco consumption and usually have a poor prognosis, with relatively few treatment options available. Any improvement in the treatment and survival of these patients is therefore an important step forward.

Immunotherapy: a broad-spectrum treatment

A previous study had determined that the PD-L1 protein is found in a wide variety of tumors and helps tumor cells dodge immune system surveillance. The original idea for this study was based on this finding, and centered on administering immunotherapy aimed at blocking PD-L1, which is found in 30% of metastatic bladder tumors, in order to outsmart tumor cell trickery of the immune system. “This protein blocks the patients´ immune response and renders it incapable of fighting cancer cells,” explains Cristina Cruz. The results of this clinical trial with an anti-PD-L1 agent confirm this approach and show that the administration of immunotherapy restores the immune response of patients, reducing the size of the tumor in 43% of treated patients with tumors positive for the PD-L1 protein.

In view of these findings, it was decided to enlarge the study group and also administer the immunotherapy agent to patients with metastatic bladder cancer with or without the presence of the PD-L1 biomarker. “The results supported the idea that immune response could be manipulated to achieve an objective reduction in tumor size in patients with advanced bladder cancer and few treatment options. The next step was to test the agent irrespective of PD-L1 marker presence,” affirms Cristina Cruz. The results evidenced that the drug also achieved an 11% response rate in the group of patients with bladder cancer without PD-L1 protein expression (PD-L1-). “For cancers with few treatment options such as bladder cancer, immunotherapy is opening up possible therapeutic avenues,” says Josep Tabernero, Principal Investigator of the study and Director of VHIO. He continues, “In our clinical trials we are starting to see very promising results that support novel immunotherapeutic strategies. Our findings are showing that immunotherapy really works and that it is poised to impact the way we will treat cancer in the future”.

Immunotherapy: a firm contender in dismantling cancer´s armory

Immunotherapy is based on using cancer patients’ own immune systems to fight cancer cells. Over recent years, immunotherapy has been shown to be effective against metastatic melanoma. Later came the more unexpected finding that it is effective against some lung and kidney tumors. This consequently spurred the cancer research community to investigate responses in other tumors types. Now, this research has shown that immunotherapy is also effective against metastatic bladder cancer, thus opening the door to potential new therapeutic options and treatment strategies.

In view of these results, a phase III trial has been designed that will soon be initiated in several Spanish hospitals.


* The Angeles Clinic and Research Institute; Pinnacle Oncology/Hematology; Carolina BioOncology Institute; Vanderbilt-Ingram Cancer Center; Institut Gustave Roussy; Comprehensive Cancer Centers of Nevada; Sarah Cannon Research Institute; Virginia Oncology Associates; New York Oncology Hematology, P.C.; Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School; Beth Israel Deaconess Medical Center; Massachusetts General Hospital; Institut Claudius Regaud; Yale Cancer Center; St. Barts Hospital and The London NHS Trust; Vall d’Hebron Institute of Oncology; Centre Léon-Bérard; Moffitt Cancer Center; Stanford University Cancer Institute; Johns Hopkins University School of Medicine.

Media contact:

Amanda Wren • Vall d’Hebron Institute of Oncology (VHIO) Communications Manager • Tel. +34 695 207 886

Margarida Mas • Vall d’Hebron Institute of Oncology (VHIO) Scientific Communication • Tel. +34 626 523 034

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