New real-world data, i.e. from clinical practice, further strengthen the therapeutic regimen which involves first-line platinum-based chemotherapy, followed by a maintenance phase with avelumab as standard of care for eligible patients suffering from locally advanced urothelial carcinoma or metastatic, which have not progressed after first-line chemotherapy. Merck anticipates this on the occasion of the annual Symposium on genitourinary tumors of the American Society of Clinical Oncology (Asco), scheduled in San Francisco from 25 to 27 January.
The data – explains a note – include real-world studies that confirm, as in the 'Javelin Bladder' clinical trial, a median overall survival of approximately 30 months in patients without progression after first-line chemotherapy. Further analyzes carried out on real-word data offer for the first time insights into the overall survival results obtained by proposing a therapeutic sequence which involves, for patients progressing from the 'Javelin Bladder' treatment regimen, the use of drug-conjugated antibodies ( Adc, Antibody-drug conjugate) such as enfortumab vedotin. Some preliminary data suggest that in patients who received therapy with an ADC, after the 'Javelin Bladder' regimen, the median survival from the start of first-line chemotherapy reached 40 months.
“Avelumab, in first-line maintenance treatment – states Philippe Barthélémy of the Institut de Cancérologie Strasbourg Europe, France – has become the standard of care for patients with locally advanced or metastatic bladder cancer, with a well-established efficacy and safety profile consolidated and supported by years of experience in daily clinical practice. These new analyzes add to the large body of scientific evidence demonstrating how maintenance treatment with avelumab can help prolong overall survival and potentially offer a better quality of life.” Furthermore, adds the expert, “the analysis of the real-world 'Avenance' study, currently underway, could provide new indications according to which the initial use of the 'Javelin Bladder' regimen, followed by second-line treatment with an ADC such as enfortumab vedotin could significantly improve overall patient survival outcomes. These results highlight the importance of strategic treatment sequencing to optimize patient outcomes.”
“The 'Javelin Bladder 100' study – observes Tamas Sütö, Senior Vice President and Head of Medical Unit Oncology at Merck – has helped transform the standard of care for patients with advanced bladder cancer at a time when, from decades, major progress has not been seen. By continuing to share new research on avelumab, including data on health-related quality of life, key patient populations, and treatment sequencing, we can further help clinicians make informed decisions about the treatment of each individual patient”.
Bladder cancer is the tenth most common cancer in the world, the note recalls. Over half a million new cases were diagnosed in 2020, with approximately 200,000 deaths from this disease globally. Urethral cancer, which accounts for about 90% of all bladder cancers, becomes more difficult to treat as it advances, spreading through the layers of the bladder wall. Only 25%-55% of patients receive second-line therapy after first-line chemotherapy.
Avelumab is a human monoclonal antibody against the programmed cell death receptor ligand PD-L1. By blocking the ligand-receptor interaction, between PD-L1 and PD-1, respectively, it has been shown in preclinical models to act by unlocking the suppression of the T cell-mediated anti-tumor immune response.
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