Against bladder cancer
New drug reduces mortality from bladder cancer by 30%
Svetlana Maslova, Hi-tech+
British scientists presented the results of the third phase of clinical trials of the new drug. The tumor response rate to treatment was 40.6%, while for chemotherapy for bladder cancer it was 17.9%. An experimental therapy based on enfortumab was previously approved in the USA due to the promising results of the second phase. Within a few months, the drug should become available to Europeans as well.
Article by Powles et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma is published in the New England Journal of Medicine – VM.
Currently, bladder cancer is treated with chemotherapy and immunotherapy, but both methods have their drawbacks. Every year, more than half a million new cases of bladder cancer and high mortality are registered in the world, so new treatment options are urgently needed.
In the third phase of clinical trials, scientists evaluated the effectiveness of the drug enfortumab from the class of drugs ADC – conjugates "antibody-drug". Enfortumab was developed by Astellas Pharma and Seagen and was previously approved for emergency use by the American FDA regulator after the results of the second phase of trials, which demonstrated a rapid decrease in tumor volume during treatment.
The final phase of the trials included 608 patients with metastatic and locally advanced urothelial carcinoma, the most common type of bladder cancer (about 90% of all cases). The participants represented 19 countries. Previously, they were treated with platinum–based chemotherapy and immunotherapy - PD-L1 immune checkpoint inhibitors. Now the experimental treatment was compared in effectiveness with chemotherapy (301 and 307 people in each group).
Observations showed that the mortality rate on the background of enfortumab was 30% lower, and the average survival rate was approximately 13 months.
The tumor response rate to treatment was 40.6%, while for chemotherapy only 17.9%. The average cancer progression-free survival was 5.6 months for the enfortumab group and 3.7 months for participants on chemotherapy.
"The new drug has led to a significant increase in survival in bladder cancer. This is an elusive result for this disease," commented co–author Tom Pauls. In addition, the results surpassed chemotherapy in every way, he added.
The safety of enfortumab for humans was assessed by scientists as acceptable. In both groups, side effects occurred in about 90% of participants, but were manageable, the authors explained.
The team is currently awaiting approval of enfortumab for use in the UK. They plan that the treatment will be available to patients in a few months.
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