Merck, Pfizer, and 4D pharma join forces for bladder cancer clinical trial

A clinical trial collaboration between 4D pharma, Merck, and Pfizer to treat locally advanced or metastatic urothelial carcinoma (UC), also known as transitional cell carcinoma (TCC), has been announced today.

The trial will evaluate MRx0518 in combination with BAVENCIO (avelumab) – which in 2020 became the first and only immunotherapy approved by the FDA in the first-line maintenance setting for advanced UC.

The treatment intends to support patients with locally advanced or metastatic UC that has not progressed following first-line platinum-containing chemotherapy.

Starting in 2021 the trial hopes to further the positive clinical outcomes achieved by the sole use of BAVENCIO, which is co-developed and co-commercialised by Germany’s Merck and US-headquartered Pfizer. The FDA granted accelerated approval for BAVENCIO in 2017 for the treatment of adults and paediatric patients 12 years of age and older with Merkel cell carcinoma, which is a rare form of skin cancer.

Duncan Peyton, Chief Executive Officer at 4D pharma, said: “4D is able to evaluate MRx0518 in a new combination and earlier treatment setting following the promising data already generated in combination with checkpoint inhibitor pembrolizumab in refractory patients, and MRx0518 monotherapy data demonstrating single agent immuno-modulation presented last year at SITC.

“This collaboration allows us to continue to build a broad understanding of the safety and efficacy of MRx0518 across a range of solid tumours and stages of disease.”

UC is the most common type of bladder cancer, which is the tenth most prevalent form of cancer in the world. As of 2018, there were 550,000 new cases of bladder cancer and 60% of these occur in higher-income countries, according to the World Cancer Research Fund.

Will Brown