Merck is discontinuing the Phase 3 KEYNOTE-630 trial evaluating (pembrolizumab, Keytruda) for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent Data Monitoring Committee (DMC).
The DMC stated that the study be stopped as the risk/benefit profile did not support continuing it.
The safety profile of pembrolizumab in this trial was consistent with the drug’s established safety profile.
Merck has informed study investigators and advises patients in the studies to speak to their study team and physician regarding next steps and treatment options. Data analyses for KEYNOTE-630 are ongoing, and the results will be shared with the scientific community and regulatory agencies.
“Our understanding of cancer and how it can be treated has rapidly evolved in recent years, but unmet needs remain across different types of cancer and stages of disease,” says Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, in a news release. “That is why we continue our rigorous exploration of innovative treatment approaches in cancers with high unmet need, such as non-small cell lung cancer and cutaneous squamous cell carcinoma, with the goal to help even more patients. We are extremely grateful to all of the patients, caregivers and investigators for their participation in these studies.”
KEYNOTE-630 is a randomized, double-blind Phase 3 trial evaluating pembrolizumab as adjuvant therapy in patients with high-risk locally advanced cSCC who have undergone surgery with or without positive margins and completed adjuvant radiotherapy compared to placebo. The primary endpoint is RFS, and key secondary endpoints include OS and safety. The trial enrolled an estimated 430 patients who were randomized to receive either:
Pembrolizumab (400 mg intravenously [IV] every six weeks [Q6W] for up to nine cycles) as adjuvant therapy following surgery and radiation; or Placebo (IV Q6W for up to nine cycles) as adjuvant therapy following surgery and radiation.
