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:

primary mediastinal B-cell lymphoma

Therapeutic Areas

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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 adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.

Keytruda is supplied as a solution for intravenous administration. The recommended dose of Keytruda in adults 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.
The recommended dose of Keytruda in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or 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 confirmatory trials.

The approval of Keytruda for PMBCL was based on data from the KEYNOTE-170 study, a multicenter, open-label, single-arm trial that included 53 patients with relapsed or refractory PMBCL. Patients were treated with Keytruda 200mg IV every 3 weeks until unacceptable toxicity or documented disease progression, or for up to 24 months for patients who did not progress; efficacy was based on overall response rate (ORR) and duration of response. Results showed that for the 24 responders, the median time to first objective response (complete or partial response) was 2.8 months (range: 2.1 to 8.5 months); median follow-up time was 9.7 months. The ORR was 45% (11% complete response, 34% partial response) while median duration of response was not reached (range: 1.1+ months to 19.2+ months).

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 primary mediastinal B-cell lymphoma, please visit https://www.keytruda.com/