Merck has announced that its Phase III AMBASSADOR trial evaluating urothelial carcinoma drug Keytruda has hit one of its two primary endpoints.

The endpoint of disease-free survival (DFS) for the adjuvant treatment of patients with localised muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma was met as part of the Phase III trial (NCT03244384).

The company has said that Keytruda (pembrolizumab) showed ‘statistically significant’ and ‘clinically meaningful’ improvement in the patients, increasing rates of DFS post-surgery.

Marjorie Green, senior vice president of Merck Research Laboratories said: “Up to half of patients with bladder cancer who undergo surgery will experience recurrence within a year, underscoring the need for new treatment options in the adjuvant setting.”

“These positive results highlight the potential of Keytruda to prevent recurrence after surgery for patients with localised muscle-invasive or locally advanced urothelial carcinoma.”

The trial is financially sponsored by the US National Cancer Institute (NCI) whilst the Alliance for Clinical Trials in Oncology designed and led the study. Additionally, Merck provided funding through a cooperative research agreement between itself and NCI.

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By GlobalData

Merck has said it has created an extensive development program for Keytruda as a therapy on its own and alongside other anti-cancer therapies across the spectrum of bladder cancers.

According to GlobalData, by January 2023, commercial sponsors dominated the clinical trial development in bladder cancer overall, with the US emerging as the key country for conducting Phase III trials in bladder cancer.

Global sales for Keytruda are expected to increase from over $17.18bn in 2021 to $33.42bn by 2028.

Global data is the parent company of Clinical Trials Arena.