MSD’s immunotherapy Keytruda has been granted an expanded label to include the treatment of certain patients with locally advanced cutaneous squamous cell carcinoma (cSCC), the second most common form of non-melanoma skin cancer.
The approval is based on data from the second interim analysis of the Phase II KEYNOTE-629 trial, which enrolled patients with recurrent or metastatic cSCC or locally advanced cSCC. It excluded patients with autoimmune disease or a medical condition that required immunosuppression.
In this trial, Keytruda (pembrolizumab) demonstrated an objective response rate (ORR) of 50%, including a complete response (CR) rate of 17% and a partial response (PR) rate of 33% in patients with locally advanced cSCC.
Among patients who responded to Keytruda treatment, 81% had a duration of response (DoR) of six months or longer while 37% had a DoR of 12 months or over.
“This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community,” said Vicki Goodman, vice president, clinical research, Merck Research Laboratories.
“Keytruda has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation. This expanded indication reinforces the role of Keytruda in this cancer type, which is the second most common form of non-melanoma skin cancer,” she added.