The phase 3 AMBASSADOR trial (also known as KEYNOTE-123) met its primary endpoint of improved disease-free survival (DFS; time from randomization to reoccurrence of tumor or death) for patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma who were treated with Keytruda (pembrolizumab versus observation after patients underwent surgery.
“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,” Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories said in a recent press release. “These positive results highlight the potential of Keytruda to prevent recurrence after surgery for patients with localized muscle-invasive or locally advanced urothelial carcinoma.”
Bladder cancer will affect about 82,290 individuals within the Unites States in 2023, according to the news release. About 50% if individuals with bladder cancer will experience a reccurrence of the cancer within the span of 12 months.
Keytruda, a monoclonal antibody, helps to detect and fight off cancer cells. The drug blocks the PD-1 protein, which can slow down the immune system. The immune system can better work to find and fight cancer once PD-1 is turned off.
AMBASSADOR is a phase 3 trial that involves patients with non-muscle-invasive, muscle-invasive and metastatic bladder cancer. Both overall survival (time from treatment until death of any cause) and DFS were observed within this trial in patients with both PD-L1 positive and PD-L1—negative disease.
A total of 702 patients were involved in the study. Participants were randomly assigned to be in one of two groups: one to receive Keytruda through an IV every three weeks for up to 18 cycles, while the other group underwent observation and received no treatment.
Keytruda is being investigated in earlier disease cancer status, as finding cancer at an earlier stage may benefit long-term survival. Twenty-five studies are being conducted for Keytruda within different cancer types, according to Merck.
The AMBASSADOR trial, conducted by Merck and sponsored by the U.S National Cancer Institute (NCI), will continue to evaluate overall survival, with the results will be announced in an upcoming meeting.
Keytruda is being investigated alone and with other medications for various stages of bladder cancer. These stages of bladder cancer include non-muscle-invasive, muscle-invasive and metastatic. Two more studies, KEYNOTE-B15 and KEYNOTE-905, are being conducted to gain further knowledge on Keytruda.
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