On September 3, 2020 Merck and Pfizer reported that Bavencio (avelumab) is now available under the UK’s Early Access to Medicines Scheme (EAMS) giving some patients with bladder cancer the chance to receive treatment with the immunotherapy before its approval in Europe (Press release, Merck & Co, SEP 3, 2020, View Source [SID1234564494]).
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The positive scientific opinion issued by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) allows patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy to get first-line maintenance treatment with the drug.
The decision rides on data from the Phase III JAVELIN Bladder 100 study, which showed a significant 7.1-month improvement in median overall survival (OS) with Bavencio as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months versus 14.3 months.
This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population, the firms noted.
Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates, but most patients will ultimately experience disease progression within nine months of initiation of treatment and only 5% of patients with metastatic disease will live longer than five years, highlighting the need for improved treatment options.
"Bladder cancer is the eleventh most common cancer in the UK, with urothelial carcinoma being the most common type of bladder cancer, accounting for 90% of all cases. However, treatment options are limited and survival rates are poor. Therefore, we are delighted by the MHRA’s positive decision to provide early access to avelumab, as there is a significant unmet need in this therapy area for new treatment options for these patients. We believe this is a major advance in the existing standard of care and will improve patient outcomes," commented Dr Mike England, medical director, Merck UK & Ireland.
"Avelumab 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," added Dr Olivia Ashman, Oncology medical director, Pfizer UK. "It is our greatest hope that our maintenance approach can eventually become part of routine clinical practice and significantly prolong survival for these patients."
Bladder cancer caused 5,612 deaths in the UK in 2017.