Keytruda (pembrolizumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved November 2018

Specific Treatments:

hepatocellular carcinoma

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General Information

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD 1)-blocking, humanized monoclonal antibody. 

Keytruda is specifically indicated for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. 

Keytruda is supplied as a solution for intravenous administration. The recommended dose of Keytruda for hepatocellular carcinoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Clinical Results

FDA Approval

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

The FDA approval of Keytruda for patients with hepatocellular carcinoma who have been previously treated with sorafenib was based on KEYNOTE 224, a single-arm, multicenter trial enrolling 104 patients with hepatocellular carcinoma. Patients were required to have disease progression on or after sorafenib or were intolerant to sorafenib, have measurable disease, and Child-Pugh Class A liver impairment. Patients received Keytruda 200 mg intravenously every 3 weeks until unacceptable toxicity, investigator-assessed confirmed disease progression (based on repeat scan at least 4 weeks from the initial scan showing progression), or completion of 24 months of Keytruda. The major efficacy outcome measure was confirmed overall response rate, as assessed by independent central review (ICR) according to RECIST 1.1 (modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ). The confirmed ICR-assessed overall response rate was 17%, with one complete response and 17 partial responses. Response durations ranged from 3.1 to 16.7 months; 89% of responders had response durations of 6 months or longer and 56% had response durations of 12 months or longer.

Side Effects

Adverse effects associated with the use of Keytruda may include, but are not limited to, the following:

fatigue

musculoskeletal pain

decreased appetite

pruritus

diarrhea

nausea

rash

pyrexia

cough

dyspnea

constipation

pain

abdominal pain

Mechanism of Action

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD 1)-blocking, humanized monoclonal IgG4 kappa 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. 

Additional Information

For additional information regarding Keytruda or hepatocellular carcinoma, please visit https://www.keytruda.com/