Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody.
Keytruda is specifically indicated as monotherapy for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
Keytruda is supplied as a solution for intravenous injection. The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks. Administer as an intravenous infusion over 30 minutes.
The FDA approval of Keytruda for recurrent or metastatic cutaneous squamous cell carcinoma was based on KEYNOTE-629, a multi-center, multi-cohort, non-randomized, open-label trial. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR). Patients received Keytruda 200 mg intravenously every three weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months. Keytruda demonstrated an ORR of 34%, with a complete response rate of 4% and a partial response rate of 31%. Among the 36 responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median DOR had not been reached (range, 2.7 to 13.1+ months).
Adverse effects associated with the use of Keytruda monotherapy may include, but are not limited to, the following:
Keytruda (pembrolizumab) is a programmed death receptor-1 (PD 1)-blocking antibody. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
For additional information regarding Keytruda or recurrent or metastatic cutaneous squamous cell carcinoma, please visit the Keytruda website.