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Keytruda (pembrolizumab)

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

Company:

Approval Status:

Approved May 2017

Specific Treatments:

microsatellite instability-high or mismatch repair deficient solid tumors and colorectal cancer

Therapeutic Areas

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 unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or  colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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 the confirmatory trials.

The FDA approval of Keytruda for adult and pediatric patients who have unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, as well as for patients with MSI-H or dMMR colorectal cancer following progression on a fluoropyrimidine, oxaliplatin and irinotecan was based on data from 149 patients with MSI-H or dMMR cancers enrolled across five single-arm clinical trials. Ninety patients had colorectal cancer (CRC) and the remaining 59 patients had one of 14 other tumor types. The objective response rate (ORR) with Keytruda was 39.6 percent, including 11 (7.4 percent) complete responses (CRs) and 48 (32.2 percent) partial responses (PRs). The ORR was 36 percent in patients with CRC and 46 percent in patients with other tumor types. The median duration of response was not yet reached (range, 1.6+ months to 22.7+ months). Among patients who responded to Keytruda, 78 percent had responses that lasted for at least six 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 microsatellite instability-high or mismatch repair deficient solid tumors and colorectal cancer, please visit https://www.keytruda.com/

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