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New data from the JAVELIN Bladder 100 Phase III study show that bavencio (avelumab) reached the primary endpoint of its overall survival rate (overall survival) in the planned midterm analysis, which was previously untreated for locally advanced or metastatic urethra cancer (UC).
Merck revealed that the drug showed a statistically significant improvement in overall survival in each common primary population: all random groups of patients and patients with PD-L1-positive tumors.
In addition to the successful results, the safety of human anti-PD-L1 antibodies in this trial is consistent with that of JAVELIN's single-drug clinical development program.
Currently, combined chemotherapy is the standard of first-line treatment for patients with advanced diseases, but unfortunately, complete remission after first-line chemotherapy is not common, with most patients experiencing disease progression within nine months of the start of treatment.
Last year, the drug disappointed in the JAVELIN Gastric 100 Phase III study, which evaluated Bavencio's role in localized late-stage or metastasis HER2-negative gastric or gastroesoesic junction (GEJ) cancer.
Chris Boshoff, Pfizer's chief development officer for oncology, said the drug was "the first immunotherapy to demonstrate in clinical trials that its overall survival rate as a first-line treatment for patients with advanced urethroid skin cancer has improved significantly statistically."latest positive data from the JAVELIN Clinical Development Program provide evidence for Bavencio's treatment of genitourinary cancer, and we look forward to discussing these results with health authorities," he continued. The
UC accounts for about 90 percent of all bladder cancer and has a five-year survival rate of only 5 percent at the time of metastasis. With the development of subtypes, subtypes become more and more difficult to treat and spread to all layers of the bladder wall, which means that there is an urgent need for other treatment options that can improve overall survival. (cyy123.com)