Announcing the new book by DermNet NZ

Download a FREE sample chapter

DOWNLOAD NOW

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

Related information

Make a donation

Donate Today

Help us to update and maintain DermNet New Zealand

Submit your images

We are expanding our image library

Contact us

History of DermNet NZ

Watch Dr Amanda Oakley presenting 'The History Of DermNet NZ' at The International Society Of Teledermatology.

Subscribe to our mailing list

* indicates required
DermNet NZ Newsletter