Merck, a distinguished science and technology company, has announced groundbreaking real-world data that further solidify the JAVELIN Bladder regimen as a preferred standard of care for patients with locally advanced or metastatic urothelial carcinoma (UC). The regimen involves first-line platinum-based chemotherapy followed by BAVENCIO® (avelumab) maintenance for eligible patients who do not progress on first-line chemotherapy.

The new data, to be presented at the 2024 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, showcase real-world studies confirming a median overall survival (OS) of approximately 30 months in patients who do not progress after first-line chemotherapy. These studies also provide valuable insights into treatment sequencing outcomes, including the first analysis of OS by next-line treatment, such as antibody-drug conjugates (ADC) like enfortumab vedotin after the JAVELIN Bladder regimen.

According to Philippe Barthélémy from Institut de Cancérologie Strasbourg Europe, France, "Avelumab in the first-line maintenance setting is a standard of care for patients with locally advanced or metastatic bladder cancer." The new analyses contribute to the substantial body of evidence supporting the efficacy and safety of avelumab maintenance treatment, emphasizing its potential to extend overall survival while enhancing the quality of life for patients.

The ongoing exploratory analysis of the real-world AVENANCE study suggests that strategic treatment sequencing, starting with the JAVELIN Bladder regimen followed by a second-line antibody-drug conjugate like enfortumab vedotin, could significantly improve overall survival outcomes for patients.

Real-world insights from the AVENANCE study in France reveal that BAVENCIO first-line maintenance treatment, following platinum-based chemotherapy, is associated with a median OS of 21.3 months. Subsequent therapies, including second-line ADC and platinum-based chemotherapy, demonstrate varying outcomes, with median OS ranging from 16.7 to 40.8 months.

Additionally, long-term efficacy analyses of the JAVELIN Bladder regimen show a consistent median OS of at least 30 months in patients who do not progress on first-line platinum-based chemotherapy. Data from U.S. and Italy real-world studies further support the positive impact of BAVENCIO first-line maintenance on overall survival.

Patient-reported outcomes from JAVELIN Bladder 100 and exploratory subgroup analyses, such as high BMI, provide additional insights into the real-world effectiveness and safety of BAVENCIO maintenance therapy. These findings contribute to Merck's ongoing commitment to advancing the standard of care for patients with advanced bladder cancer and guiding informed treatment decisions for clinicians.