Merck details win for Keytruda in bladder cancer after surgery

Merck's Keytruda, a PD-1 inhibitor, has shown positive results in a phase III trial for the treatment of bladder cancer after surgery. Keytruda demonstrated a 31% reduction in the risk of disease recurrence or death compared to the control arm in high-risk patients with localized muscle-invasive bladder cancer. The median time that patients were alive and disease-free was more than doubled, from 14 months in the control arm to 29 months with Keytruda.

These results are part of the AMBASSADOR trial, which is ongoing and will continue to assess the effects of Keytruda on overall survival. If the AMBASSADOR results eventually lead to FDA approval, Keytruda would be able to cover a broader spectrum of bladder cancer patients. In 2020, the drug was approved to treat certain patients with non-muscle invasive bladder cancer, and more recently, the FDA endorsed the drug, along with Padcev, as a first-line treatment for advanced bladder cancer.

Despite radical surgery, up to half of patients with muscle-invasive bladder cancer still experience high rates of cancer recurrence. The current data show the promise of using Keytruda after surgery for certain high-risk patients, according to Andrea Apolo, M.D., a principal investigator at the Center for Cancer Research of the National Cancer Institute. The study's results were consistent with Keytruda's established safety profile, and no new signals of adverse events were observed.