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Oct 5, 2020 /--- According to a Phase III clinical trial led by Queen Mary College and Bartz Cancer Centre, University of London, an immunotherapy drug called "avelumab" has been shown to significantly improve survival rates in patients with the most common type of bladder cancer, known as urethra cancer.
this is the first time immunotherapy has brought a survival advantage to bladder cancer patients, potentially benefiting thousands of patients each year.
study was published in the September 24, 2020 issue of the journal NEJM under the title "Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma."
the dual mechanism of Avelumab, pictured from Annals of Oncology, 2017, doi:10.1093/annonc/mdx170.
clinical trial found that avelumab, an anti-PD-L1 antibody, reduced the risk of death from bladder cancer by 31% and extended the medium survival of advanced bladder cancer by more than seven months.
about 550,000 new cases of bladder cancer are diagnosed each year (10,200 of them in the UK), making it the world's 10th most common cancer.
clinical trial focuses on groups of bladder cancer patients (advanced or stage 4) where cancer has spread beyond the bladder, a late-stage disease that is difficult to treat and kills more than 200,000 people worldwide each year.
chemotherapy is currently the initial standard method for treating this advanced cancer.
after chemotherapy, patients are regularly examined because the cancer tends to return quickly.
when it relapses, it is difficult to treat and clinical results are poor.
The Phase III global trial, called JAVELIN Bladder 100, funded by Pfizer and Merck KGaA of Germany, assessed the efficacy of the immunotherapy drug avelumab in patients with locally advanced or metastatic urethra cancer who did not progress after chemotherapy treatment.
then, 700 patients from more than 200 locations around the world were assigned to two treatment groups after completing chemotherapy--- one group received only regular check-ups (standard care) and the other received avelumab treatment outside of standard care.
treatment with avelumab, the risk of death was reduced by 31%, with a medium total survival of 21.4 months and a medium total survival of 14.3 months for patients who were not treated with the drug.
side effects met the expectations of immunotherapy, with 11 percent of patients stopping avelumab treatment due to treatment problems.
The first-line treatment of metastatic bladder cancer has a survival advantage," said Thomas Powles, author of the paper and professor of urological oncology at Queen Mary College, University of London.
we have observed that avelumab significantly reduces the risk of death and brings significant overall survival benefits, highlighting the potential of this immunotherapy to change patient practice.
highlight the potential benefits of using avelumab for maintenance therapy after chemotherapy to prolong life.
, the early-stage drug program (EAMS) is an option for bladder cancer patients who have benefited from chemotherapy, which meets the standards of the Javelin Bladder clinical trial.
in the UK, avelumab will now be available to patients with advanced/metastatic urethra skin cancer through the EAMS programme.
. In the United States, the U.S. Food and Drug Administration (FDA) has approved avelumab for the maintenance of treatment for patients with localized advanced or metastatic urinary tract cancer who have not progressed after treatment with first-line platinum-containing chemotherapy, based on the results of the JAVELIN Bladder 100 clinical trial.
avelumab is an immunotherapy drug that is an immuno-checkpoint inhibitor that blocks a protein called PD-L1 on the surface of tumor cells.
when PD-L1 is active, it helps cancer evade the immune system.
by blocking PD-L1, the immune system can more easily identify and kill cancer.
(bioon.com) Reference: 1. Thomas Powles et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. NEJM, 2020, doi:10.1056/NEJMoa2002788.2.Avelumab for Advanced or Metast Urothelial Carcinoma improves in advanced bladder cancer patients.