New data released from the Phase III JAVELIN Bladder 100 study in previously untreated locally advanced or metastatic urothelial carcinoma (UC) has shown that Bavencio (avelumab) met its primary endpoint of overall survival (OS) at a planned interim analysis.

Merck revealed that the drug demonstrated a statistically significant improvement in OS in each of the co-primary populations: all randomised patients and patients with PD-L1–positive tumours.

Further to the successful results, the safety profile for the human anti-PD-L1 antibody in the trial was consistent with that in the JAVELIN monotherapy clinical development program.

Combination chemotherapy is currently the first-line standard of care for patients with advanced disease, but unfortunately complete responses following first-line chemotherapy are uncommon, and most patients will experience disease progression within nine months after treatment initiation.

Last year the drug disappointed in the Phase III JAVELIN Gastric 100 study, which evaluated Bavencio in locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer.

The drug is the “first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma,” said Chris Boshoff, chief development officer, Oncology at Pfizer.

He continued, “These latest positive data from the JAVELIN clinical development program add to the body of evidence for Bavencio in the treatment of genitourinary cancers, and we look forward to discussing these results with health authorities.”

UC accounts for about 90% of all bladder cancer, which when metastatic has a five-year survival rate of just 5%. The subtype becomes harder to treat as it advances, spreading through the layers of the bladder wall, meaning there is an urgent need for additional treatment options that improve overall survival.