Avelumab maintenance extends OS in advanced urothelial carcinoma
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The addition of maintenance avelumab to best supportive care extended OS for patients with previously untreated locally advanced or metastatic urothelial carcinoma, according to study results released by the agent’s manufacturer.
Urothelial carcinoma accounts for approximately 90% of bladder cancer cases. Only 5% of patients with metastatic disease survive 5 years.
Combination chemotherapy is the standard first-line treatment for those with advanced disease. Response rates typically are high, but most patients experience disease progression within 9 months of treatment initiation.
The randomized phase 3 JAVELIN Bladder 100 study included 700 patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy.
Researchers randomly assigned patients to best supportive care with or without first-line maintenance therapy with avelumab (Bavencio; EMD Serono, Pfizer), an anti-PD-L1 antibody.
OS served as the primary endpoint. Secondary endpoints included PFS, antitumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes.
Results of an interim analysis showed a statistically significant improvement in OS with avelumab among all patients, as well as those with PD-L1-positive tumors.
Avelumab exhibited a safety profile consistent with prior studies.
Complete data from the trial will be submitted for presentation at an upcoming scientific meeting. Healio will continue to follow this trial and publish more detailed results when they are available.
“Bavencio 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,” Chris Boshoff, MD, PhD, chief development officer for oncology with Pfizer Global Product Development, said in a press release. “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.”
These results represent “a major advance on the existing standard of care” and could make this treatment approach part of routine clinical practice, Luciano Rossetti, head of global research and development for EMD Serono, said in the press release.
The FDA approved avelumab in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or who experienced disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.