FDA Approves Expanded Indication for Keytruda in Recurrent or Metastatic cSCC


The Food and Drug Administration has approved pembrolizumab for the treatment of patients with a locally advanced form of skin cancer.

The FDA has approved an extended indication for pembrolizumab (Keytruda) for patients with recurrent or metastatic, or locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation, according to Merck, the manufacturer of the immunotherapy agent.

“This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. 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,” said Vicki Goodman, MD, vice president, clinical research, Merck Research Laboratories, in a press release. “This expanded indication reinforces the role of Keytruda in this cancer type, which is the second most common form of non-melanoma skin cancer.”

The approval was based off findings from the multicenter, multi-cohort, non-randomized, open label, phase 2 KEYNOTE-629 trial (NCT03284424). The study assessed patients with recurrent or metastatic, or locally advanced cSCC, excluding patients with autoimmune disease or medical conditions requiring immunosuppression.

The patients treated with pembrolizumab demonstrated an overall response rate (ORR) of 50%, which included 17% complete and 33% partial response rates. In a range of follow-up times spanning from 1.0 to 17.2 months, (the average follow-up time was 13.4 months), 81% of patients had a duration of response (DOR) greater than 6 months while 37% reported a DOR greater than 12 months.

The median duration of exposure to pembrolizumab was 6.9 months for the 159 patients enrolled in the trial.

Adverse events (AEs) among the patients with recurrent or metastatic, or locally advanced cSCC were comparable to those reported in the 2,799 patients who were administered pembrolizumab as a single agent to treat their melanoma or non-small cell lung cancer.

Potentially fatal or severe immune-mediated AEs included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. For more severe AEs, it may be appropriate to administer corticosteroids in place of pembrolizumab, according to the release. Grade 3 to 4 laboratory abnormalities that appeared at a higher incidence included lymphopenia (10%) and decreased sodium (10%).


FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC). News release. Merck. July 6, 2021. Accessed July 6, 2021. https://www.merck.com/news/fda-approves-expanded-indication-for-mercks-keytruda-pembrolizumab-in-locally-advanced-cutaneous-squamous-cell-carcinoma-cscc/

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