Keytruda (pembrolizumab)

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

Company:

Approval Status:

Approved June 2018

Specific Treatments:

recurrent or metastatic cervical cancer

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General Information

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

Keytruda is specifically indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Keytruda is supplied as a solution for intravenous administration. The recommended dose of Keytruda for cervical cancer 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 was 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 efficacy of Keytruda was investigated in 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort (Cohort E) in KEYNOTE-158, a multicenter, non-randomized, open-label, multi-cohort trial. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. Patients received Keytruda 200 mg intravenously every 3 weeks until unacceptable toxicity or documented disease progression. Patients without disease progression could be treated for up to 24 months. Assessment of tumor status was performed every 9 weeks for the first 12 months, and every 12 weeks thereafter. The major efficacy outcome measures were ORR according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by blinded independent central review, and duration of response. Among the 98 patients, approval was based on 77 (79%) patients who had tumors that expressed PD-L1 with a CPS ≥1 and who had received at least one line of chemotherapy for metastatic disease. PD-L1 status was determined using the PD-L1 IHC 22C3 pharmDx Kit. With a median follow-up time of 11.7 months, the ORR in 77 patients was 14.3%, including 2.6% complete responses and 11.7% partial responses. The estimated median response duration based on 11 patients with a response by independent review was not reached; 91% had a response duration of greater than or equal to 6 months. No responses were observed in patients whose tumors did not have PD-L1 expression (CPS ˂1).

Side Effects

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

fatigue

pain

pyrexia

peripheral edema

musculoskeletal pain

diarrhea/colitis

abdominal pain

nausea

vomiting

constipation

decreased appetite

hemorrhage

UTI

infections

rash

hypothyroidism

headache

dyspnea

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 recurrent or metastatic cervical cancer, please visit https://www.keytruda.com/