Key clinical-trial evidence for pembrolizumab

Author: Anoma Ranaweera B.V. Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, December 2014.

Pembrolizumab is a highly selective humanized monoclonal antibody directed against the PD-1 receptor on T-cells. The drug blocks the PD-1 receptor, thereby preventing the formation of PD-1/PD-L1 (programme death ligand one) complexes. This mechanism causes the activation of T-cell mediated immune responses against tumour cells.

On September 4, 2014 the US Food and Drug Administration (FDA) approved pembrolizumab as a breakthrough therapy for the treatment of metastatic melanoma, based on response rates demonstrated in clinical trial data from 173 patients with melanoma in a cohort of the KEYNOTE-001 study.

KEYNOTE-001 study

Table 1 Drug-related adverse reactions in >10% of patients
Pembrolizumab 2 mg/kg every 3 weeks (n = 89)
Adverse reactionAll grades (%)Grade 3 (%)
General disorders and administration site conditions
Fatigue 47 7
Peripheral oedema 17 1
Chills 14 0
Pyrexia 11 0
Gastrointestinal disorders
Diarrhoea 20 0
Nausea 30 0
Abdominal pain 12 0
Respiratory disorders
Cough 30 1
Dyspnoea 18 2
Skin disorders
Rash 29 0
Pruritus 30 0
Vitiligo 11 0
Musculoskeletal disorders
Arthralgia 20 0
Myalgia 14 1
Back pain 12 1
Nervous system disorders
Headache 16 0
Dizziness 11 0
Liver function
Increased AST 24 2

Future directions

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