Merck shares positive results for Keytruda in phase 3 bladder cancer study
31 Jan 2024
Phase 3Clinical ResultASCO
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Source: PMLiVE
Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage study of Keytruda (pembrolizumab) in a subset of bladder cancer patients.
The phase 3 AMBASSADOR/KEYNOTE-123 trial has been evaluating the anti-PD-1 therapy as an adjuvant treatment for high-risk patients with localised muscle-invasive urothelial carcinoma and locally advanced resectable urothelial carcinoma.
According to the results presented at this year's American Society of Clinical Oncology Genitourinary Cancers Symposium, Keytruda demonstrated a statistically significant and clinically meaningful improvement in one of the study’s dual primary endpoints of disease-free survival (DFS) after a median follow-up of 22.3 months, reducing the risk of disease recurrence or death by 31% versus observation in these patients after surgery.
The trial’s second dual primary endpoint of overall survival did not reach statistical significance at the time of the pre-specified interim analysis and will continue to be followed as data mature, Merck said.
Approximately 83,000 people in the US are expected to be diagnosed with bladder cancer this year, with muscle-invasive bladder cancer accounting for up to 25% of new cases.
Muscle-invasive bladder cancer is a form of the disease that has spread into the deep muscle of the bladder wall, while locally advanced urothelial cancer is a cancer that begins in the urothelial cells and has spread to nearby tissue or lymph nodes.
Despite surgery, up to 50% of patients with muscle-invasive bladder cancer experience recurrence within 12 months.
Dr Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said: “This phase 3 data marks the first time Keytruda has shown a clinically meaningful improvement in DFS as adjuvant therapy in urothelial carcinoma.
“Results from this pivotal study support Keytruda as a potential new adjuvant option for these patients and demonstrate the expanding role of Keytruda into earlier stages of resectable muscle-invasive bladder cancer.”
The therapy already holds approvals to treat a wide variety of cancers, including specific cases of locally advanced or metastatic urothelial carcinoma and non-muscle-invasive bladder cancer.
There are also currently more than 1,600 trials studying Keytruda, including the phase 3 KEYNOTE-564 study that has been evaluating the therapy in a subset of kidney cancer patients.
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